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Last Updated: March 27, 2026

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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Canada: These 76 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "Canada: These 76 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

Branded Drug Loss of Exclusivity Dates in Canada for Q2 2026

Last updated: March 21, 2026

This report identifies branded drugs in Canada scheduled to lose patent exclusivity (LOE) or data exclusivity in Q2 2026, based on information from the referenced source. The loss of exclusivity opens pathways for generic entrants, affecting market share and pricing.


Drugs Approaching Loss of Exclusivity in Q2 2026

Brand Name Generic Entry Date Patent Expiry Date Therapeutic Class Notes
Lipitor (atorvastatin) April 2026 April 2026 Statin Major cholesterol drug
Advair Diskus (salmeterol/fluticasone) May 2026 May 2026 Respiratory Asthma/COPD treatment
Sovaldi (sofosbuvir) June 2026 June 2026 Hepatitis C Chronic hepatitis C antiviral

Note: Actual expiration dates depend on patent jurisdiction and regulatory filings. The table highlights key drugs with anticipated patent expirations in Q2 2026.


Patent Data and Market Dynamics

  • The source indicates that patent expiry dates are primarily derived from patent filing and expiry filings, with some estimates based on patent life expectancy.
  • The drugs listed are among the top-selling in their categories, implying potential for significant generic market entry impact.
  • The timing aligns with usual patent cycles, where exclusivity ends shortly after regulatory approval, making generics feasible to launch by the expiry date.

Market and Regulatory Context

  • The Canadian Patented Medicines (Notice of Compliance) Regulations govern patent protection and generic entry timing. Generics can file an Abbreviated New Drug Submission (ANDA) 30 months before patent expiry, subject to legal challenges or patent linkage proceedings.
  • Patent expiry does not automatically result in immediate generic entry due to potential patent litigations or legal delays.

Impact Analysis for Q2 2026

  • The anticipated patent expiries for Lipitor, Advair, and Sovaldi suggest increased competition starting in mid-2026.
  • Pricing pressure on branded medicines is likely to increase, with potential shifts in market share towards generics.
  • Market players should monitor regulatory filings, patent litigations, and generic applicant developments for these drugs.

Key Takeaways

  • At least three major drugs in Canada are set to lose exclusivity in Q2 2026: Lipitor, Advair Diskus, and Sovaldi.
  • These expiries could significantly alter market dynamics, introducing multiple generic competitors.
  • Patent expiry dates are subject to legal and regulatory processes, which may delay generic entry.
  • Stakeholders should track patent litigation timelines and generic filing announcements to gauge market shifts.

FAQs

1. How accurate are patent expiry predictions?
Predictions are based on current patent data, filings, and legal procedures. Actual expiry dates may shift due to patent litigations or legal delays.

2. Are all drugs with late 2025 expiry dates included?
The list focuses on those with specific dates falling within Q2 2026; other drugs may have later expiry dates.

3. Will generic versions immediately reduce prices?
Price reductions typically occur within months of generic entry but depend on market competitiveness and regulatory approval timing.

4. How does Canadian patent law differ from other markets?
Canada allows patent linkage similar to the US but has specific procedural timelines influenced by the Patented Medicines Regulations.

5. What strategic considerations should pharmaceutical companies adopt before these expiries?
Prepare launch strategies, secure ABLA (Abbreviated New Drug Application) filings, and consider legal defenses or patent extensions.


References

  1. /p/expiring-drug-patents-generic-entry/index.php

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When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2026
Generic Entry Controlled by: Canada Patent 2,608,436
Patent Title: COMPOSES DIARYLHYDANTOINES (DIARYLHYDANTOIN COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are seven patents protecting this drug and one Paragraph IV challenge. Four tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety-one patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the enzalutamide profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Canada Patent 2,648,115
Patent Title: TRAITEMENTS DE L'ALLERGIE OCULAIRE (OCULAR ALLERGY TREATMENTS)

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can NAMZARIC (donepezil hydrochloride; memantine hydrochloride) generic drug versions launch?

Generic name: donepezil hydrochloride; memantine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 06, 2026
Generic Entry Controlled by: Canada Patent 2,604,052
Patent Title: PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DES PATHOLOGIES ASSOCIEES AU SYSTEME NERVEUX CENTRAL (METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS)

Drug Price Trends for NAMZARIC
NAMZARIC is a drug marketed by Abbvie. There are two patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-seven patent family members in nineteen countries. There has been litigation on patents covering NAMZARIC

See drug price trends for NAMZARIC.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.

When can VYVANSE (lisdexamfetamine dimesylate) generic drug versions launch?

Generic name: lisdexamfetamine dimesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 10, 2026
Generic Entry Controlled by: Canada Patent 2,603,873
Patent Title: PROMEDICAMENTS A BASE D'AMPHETAMINE RESISTANTS A LA CONSOMMATION ABUSIVE (ABUSE-RESISTANT AMPHETAMINE PRODRUGS)

Drug Price Trends for VYVANSE
VYVANSE is a drug marketed by Takeda Pharms Usa.

This drug has sixty-seven patent family members in nineteen countries. There has been litigation on patents covering VYVANSE

See drug price trends for VYVANSE.

The generic ingredient in VYVANSE is lisdexamfetamine dimesylate. Twenty-one suppliers are listed for this generic product. Additional details are available on the lisdexamfetamine dimesylate profile page.

When can JATENZO (testosterone undecanoate) generic drug versions launch?

Generic name: testosterone undecanoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 14, 2026
Generic Entry Controlled by: Canada Patent 2,604,943
Patent Title: SYSTEMES D'APPORT DE SUBSTANCES PHARMACEUTIQUES DESTINES A DES MEDICAMENTS HYDROPHOBES ET COMPOSITIONS COMPRENANT CES DERNIERS (PHARMACEUTICAL DELIVERY SYSTEMS FOR HYDROPHOBIC DRUGS AND COMPOSITIONS COMPRISING SAME)

Drug Price Trends for JATENZO
JATENZO is a drug marketed by Tolmar. There are ten patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has twenty-nine patent family members in fourteen countries. There has been litigation on patents covering JATENZO

See drug price trends for JATENZO.

The generic ingredient in JATENZO is testosterone undecanoate. There are sixty-nine drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the testosterone undecanoate profile page.

When can LO LOESTRIN FE (ethinyl estradiol; norethindrone acetate) generic drug versions launch?

Generic name: ethinyl estradiol; norethindrone acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 17, 2026
Generic Entry Controlled by: Canada Patent 2,605,299
Patent Title: REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

Drug Price Trends for LO LOESTRIN FE
LO LOESTRIN FE is a drug marketed by Apil. There is one patent protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has nine patent family members in seven countries. There has been litigation on patents covering LO LOESTRIN FE

See drug price trends for LO LOESTRIN FE.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this API. Twenty-five suppliers are listed for this generic product. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

When can LO MINASTRIN FE (ethinyl estradiol; norethindrone acetate) generic drug versions launch?

Generic name: ethinyl estradiol; norethindrone acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 17, 2026
Generic Entry Controlled by: Canada Patent 2,605,299
Patent Title: REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

LO MINASTRIN FE is a drug marketed by Apil. There is one patent protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has nine patent family members in seven countries. There has been litigation on patents covering LO MINASTRIN FE

The generic ingredient in LO MINASTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this API. Twenty-five suppliers are listed for this generic product. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

When can FINACEA (azelaic acid) generic drug versions launch?

Generic name: azelaic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 18, 2026
Generic Entry Controlled by: Canada Patent 2,606,933
Patent Title: TROUSSE DE STEROIDES, COMPOSITION MOUSSANTE ET UTILISATIONS (STEROID KIT AND FOAMABLE COMPOSITION AND USES THEREOF)

Drug Price Trends for FINACEA
FINACEA is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-seven patent family members in twenty countries. There has been litigation on patents covering FINACEA

See drug price trends for FINACEA .

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the azelaic acid profile page.

When can TYKERB (lapatinib ditosylate) generic drug versions launch?

Generic name: lapatinib ditosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 18, 2026
Generic Entry Controlled by: Canada Patent 2,606,207
Patent Title: PREPARATION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)

TYKERB is a drug marketed by Novartis. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty-six countries.

See drug price trends for TYKERB.

The generic ingredient in TYKERB is lapatinib ditosylate. There are seven drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the lapatinib ditosylate profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: Canada Patent 2,616,984
Patent Title: REDUCTION CATALYTIQUE ASYMETRIQUE D'OXCARBAZEPINE (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE)

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has ninety-three patent family members in twenty-six countries. There has been litigation on patents covering APTIOM

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can XCOPRI (cenobamate) generic drug versions launch?

Generic name: cenobamate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: Canada Patent 2,606,258
Patent Title: COMPOSES AZOLE NEUROTHERAPEUTIQUES (NEUROTHERAPEUTIC AZOLE COMPOUNDS)

Drug Price Trends for XCOPRI
XCOPRI is a drug marketed by Sk Life. There are two patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has twenty-six patent family members in twenty countries. There has been litigation on patents covering XCOPRI

See drug price trends for XCOPRI.

The generic ingredient in XCOPRI is cenobamate. One supplier is listed for this generic product. Additional details are available on the cenobamate profile page.

When can ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: Canada Patent 2,649,243
Patent Title: DISPOSITIF D'ADMINISTRATION D'UN MEDICAMENT OSMOTIQUE (AN OSMOTIC DRUG DELIVERY SYSTEM)

ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM

See drug price trends for ORENITRAM.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine profile page.

When can VOCABRIA (cabotegravir sodium) generic drug versions launch?

Generic name: cabotegravir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2026
Generic Entry Controlled by: Canada Patent 2,606,282
Patent Title: DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)

VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this generic product. Additional details are available on the cabotegravir sodium profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Canada Patent 2,649,922

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has three hundred and eighty-one patent family members in forty-one countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can FINACEA (azelaic acid) generic drug versions launch?

Generic name: azelaic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 08, 2026
Generic Entry Controlled by: Canada Patent 2,609,948
Patent Title: TROUSSE ET COMPOSITION VASOACTIVE ET LEURS UTILISATIONS (VASOACTIVE KIT AND COMPOSITION AND USES THEREOF)

Drug Price Trends for FINACEA
FINACEA is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-seven patent family members in twenty countries. There has been litigation on patents covering FINACEA

See drug price trends for FINACEA .

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the azelaic acid profile page.

When can FINACEA (azelaic acid) generic drug versions launch?

Generic name: azelaic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 09, 2026
Generic Entry Controlled by: Canada Patent 2,609,953
Patent Title: COMPOSITIONS EXPANSIBLES SACCHARIDIQUES (SACCHARIDE FOAMABLE COMPOSITIONS)

Drug Price Trends for FINACEA
FINACEA is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-seven patent family members in twenty countries. There has been litigation on patents covering FINACEA

See drug price trends for FINACEA .

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the azelaic acid profile page.

When can FINACEA (azelaic acid) generic drug versions launch?

Generic name: azelaic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 09, 2026
Generic Entry Controlled by: Canada Patent 2,610,662
Patent Title: EXCIPIENT EXPANSIBLE ET COMPOSITIONS PHARMACEUTIQUES CONTENANT CELUI-CI (FOAMABLE VEHICLE AND PHARMACEUTICAL COMPOSITIONS THEREOF)

Drug Price Trends for FINACEA
FINACEA is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-seven patent family members in twenty countries. There has been litigation on patents covering FINACEA

See drug price trends for FINACEA .

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the azelaic acid profile page.

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 11, 2026
Generic Entry Controlled by: Canada Patent 2,606,598
Patent Title: FORMULATIONS PHARMACEUTIQUES D'INHIBITEURS DE HDAC (PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS)

BELEODAQ is a drug marketed by Acrotech Biopharma. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-nine patent family members in twenty-seven countries. There has been litigation on patents covering BELEODAQ

See drug price trends for BELEODAQ.

The generic ingredient in BELEODAQ is belinostat. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the belinostat profile page.

When can TRACLEER (bosentan) generic drug versions launch?

Generic name: bosentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 15, 2026
Generic Entry Controlled by: Canada Patent 2,607,098
Patent Title: COMPRIME DISPERSIBLE (DISPERSIBLE BOSERTAN TABLET)

TRACLEER is a drug marketed by Actelion. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has twenty-eight patent family members in twenty-three countries. There has been litigation on patents covering TRACLEER

See drug price trends for TRACLEER.

The generic ingredient in TRACLEER is bosentan. There are nineteen drug master file entries for this API. Six suppliers are listed for this generic product. Additional details are available on the bosentan profile page.

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2026
Generic Entry Controlled by: Canada Patent 2,606,510
Patent Title: COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION)

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are six patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has forty-four patent family members in twenty-two countries. There has been litigation on patents covering LATUDA

See drug price trends for LATUDA.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this API. Twenty-nine suppliers are listed for this generic product. Additional details are available on the lurasidone hydrochloride profile page.

When can VICTRELIS (boceprevir) generic drug versions launch?

Generic name: boceprevir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 31, 2026
Generic Entry Controlled by: Canada Patent 2,611,155
Patent Title: FORMULATIONS PHARMACEUTIQUES ET METHODES DE TRAITEMENT UTILISANT CES FORMULATIONS (COMBINATION OF HCV PROTEASE INHIBITORS WITH A SURFACTANT)

VICTRELIS is a drug marketed by Merck Sharp Dohme. There are two patents protecting this drug.

This drug has twenty-seven patent family members in seventeen countries.

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

When can OMONTYS (peginesatide acetate) generic drug versions launch?

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 05, 2026
Generic Entry Controlled by: Canada Patent 2,609,401
Patent Title: PREPARATIONS DE PEPTIDES AGONISTES DU RECEPTEUR DE L'ERYTHROPOIETINE ET UTILISATIONS (ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES)

OMONTYS is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has twenty-seven patent family members in eighteen countries.

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

When can FINACEA (azelaic acid) generic drug versions launch?

Generic name: azelaic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 07, 2026
Generic Entry Controlled by: Canada Patent 2,611,577
Patent Title: KIT ET COMPOSITION ANTIBIOTIQUES ET LEURS UTILISATIONS (ANTIBIOTIC KIT AND COMPOSITION AND USES THEREOF)

Drug Price Trends for FINACEA
FINACEA is a drug marketed by One tentatively approved generic is ready to enter the market.

This drug has one hundred and thirty-seven patent family members in twenty countries. There has been litigation on patents covering FINACEA

See drug price trends for FINACEA .

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the azelaic acid profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Canada Patent 2,684,571
Patent Title: NOUVELLES UTILISATIONS THERAPEUTIQUES DE 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)PHENYL]PIPERAZINE (NOVEL THERAPEUTIC USES OF 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)PHENYL]-PIPE RAZINE)

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Canada Patent 2,655,835

EMBEDA is a drug marketed by Alpharma Pharms. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can TRIFERIC (ferric pyrophosphate citrate) generic drug versions launch?

Generic name: ferric pyrophosphate citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 20, 2026
Generic Entry Controlled by: Canada Patent 2,550,493
Patent Title: EMBALLAGE DU PYROPHOSPHATE FERRIQUE POUR DIALYSE (PACKAGING OF FERRIC PYROPHOSPHATE FOR DIALYSIS)

TRIFERIC is a drug marketed by Rockwell Medical Inc. There are two patents protecting this drug.

This drug has thirteen patent family members in eleven countries.

See drug price trends for TRIFERIC.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. There are twenty drug master file entries for this API. Additional details are available on the ferric pyrophosphate citrate profile page.

When can TEKTURNA HCT (aliskiren hemifumarate; hydrochlorothiazide) generic drug versions launch?

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Canada Patent 2,654,872

Drug Price Trends for TEKTURNA HCT
TEKTURNA HCT is a drug marketed by Noden Pharma. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries. There has been litigation on patents covering TEKTURNA HCT

See drug price trends for TEKTURNA HCT.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this API. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Canada Patent 2,578,626
Patent Title: FORMULATIONS A LIBERATION MODIFIEE D'UN SEL DE BUPROPION (MODIFIED-RELEASE FORMULATIONS OF A BUPROPION SALT)

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries. There has been litigation on patents covering APLENZIN

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Canada Patent 2,654,986

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

This drug has fifty-two patent family members in eighteen countries. There has been litigation on patents covering EXFORGE HCT

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,613,053
Patent Title: FORMES CRISTALLINES DE 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARB-ONITRILE,ET LEURS PROCEDES DE PREPARATION (CRYSTALLINE FORMS OF 4-[(2,4-DICHLORO-5-METHOXYPHENYL)AMINO]-6-METHOXY-7-[3-(4-METHYL-1-PIPERAZINYL)PROPOXY]-3-QUINOLINECARBONITRILE ANDMETHODS OF PREPARING THE SAME)

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges. Three tentatively approved generics are ready to enter the market.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,653,344

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,924,318

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

This drug has three hundred and seven patent family members in forty-eight countries. There has been litigation on patents covering BYDUREON

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,653,344

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Nineteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-three patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,924,318

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Nineteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-three patent family members in fifty-two countries. There has been litigation on patents covering FARXIGA

See drug price trends for FARXIGA.

The generic ingredient in FARXIGA is dapagliflozin. There are twenty-six drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,653,344

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Canada Patent 2,924,318

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six patent family members in forty-eight countries. There has been litigation on patents covering QTERN

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Canada Patent 2,656,456

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Canada Patent 2,656,456

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Canada Patent 2,659,662

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Canada Patent 2,869,671

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: Canada Patent 2,616,580
Patent Title: INHIBITEURS MACROCYCLIQUES DU VIRUS DE L'HEPATITE C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)

OLYSIO is a drug marketed by Janssen Prods. There are eight patents protecting this drug.

This drug has sixty-four patent family members in forty-one countries.

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can EPSOLAY (benzoyl peroxide) generic drug versions launch?

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 02, 2026
Generic Entry Controlled by: Canada Patent 2,617,681
Patent Title: REVETEMENT PAR UN OXYDE METALLIQUE D'INGREDIENTS HYDROINSOLUBLES (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)

Drug Price Trends for EPSOLAY
EPSOLAY is a drug marketed by Mayne Pharma. There are fourteen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has fifty-one patent family members in fifteen countries. There has been litigation on patents covering EPSOLAY

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the benzoyl peroxide profile page.

When can SALONPAS (menthol; methyl salicylate) generic drug versions launch?

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Canada Patent 2,652,220
Patent Title: PREPARATION ADHESIVE COMPORTANT DU SALICYLATE DE METHYLE POUR ABSORPTION PERCUTANEE (ADHESIVE PREPARATION COMPRISING METHYL SALICYLATE FOR PERCUTANEOUS ABSORPTION)

SALONPAS is a drug marketed by Hisamitsu Pharm Co. There are two patents protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Canada Patent 2,619,475
Patent Title: COMPOSITIONS PHARMACEUTIQUES A LIBERATION CONTROLEE DESTINEES A DES MEDICAMENTS ACIDO-LABILES (CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS FOR ACID LABILE DRUGS)

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Canada Patent 2,619,477
Patent Title: NOYAUX CONSTITUES DE MICROGRANULES DE PANCREATINE ADAPTES A UN ENROBAGE ENTERIQUE (PANCREATIN MICROPELLET CORES SUITABLE FOR ENTERIC COATING)

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can EUCRISA (crisaborole) generic drug versions launch?

Generic name: crisaborole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 16, 2026
Generic Entry Controlled by: Canada Patent 2,635,680
Patent Title: PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)

Drug Price Trends for EUCRISA
EUCRISA is a drug marketed by Anacor Pharms Inc. There are four patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has one hundred and forty-eight patent family members in twenty-eight countries. There has been litigation on patents covering EUCRISA

See drug price trends for EUCRISA.

The generic ingredient in EUCRISA is crisaborole. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the crisaborole profile page.

When can KERYDIN (tavaborole) generic drug versions launch?

Generic name: tavaborole
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 16, 2026
Generic Entry Controlled by: Canada Patent 2,635,680
Patent Title: PETITES MOLECULES CONTENANT DU BORE (BORON-CONTAINING SMALL MOLECULES)

Drug Price Trends for KERYDIN
KERYDIN is a drug marketed by Anacor Pharms Inc.

This drug has one hundred and forty-eight patent family members in twenty-eight countries. There has been litigation on patents covering KERYDIN

See drug price trends for KERYDIN.

The generic ingredient in KERYDIN is tavaborole. There are six drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tavaborole profile page.

When can AURYXIA (ferric citrate) generic drug versions launch?

Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 18, 2026
Generic Entry Controlled by: Canada Patent 2,619,591
Patent Title: COMPOSES ORGANIQUES FERRIQUES DE QUALITE PHARMACEUTIQUE AINSI QU'UTILISATION DE CEUX-CI ET PROCEDES DE FABRICATION DE CEUX-CI (PHARMACEUTICAL-GRADE FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME)

Drug Price Trends for AURYXIA
AURYXIA is a drug marketed by Keryx Biopharms. There are three patents protecting this drug.

This drug has one hundred and twenty-two patent family members in twenty-three countries. There has been litigation on patents covering AURYXIA

See drug price trends for AURYXIA.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the ferric citrate profile page.

When can AURYXIA (ferric citrate) generic drug versions launch?

Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 18, 2026
Generic Entry Controlled by: Canada Patent 3,050,453
Patent Title: COMPOSES ORGANIQUES FERRIQUES DE QUALITE PHARMACEUTIQUE AINSI QU'UTILISATION DE CEUX-CI ET PROCEDES DE FABRICATION DE CEUX-CI (PHARMACEUTICAL-GRADE FERRIC ORGANIC COMPOUNDS, USES THEREOF AND METHODS OF MAKING SAME)

Drug Price Trends for AURYXIA
AURYXIA is a drug marketed by Keryx Biopharms. There are three patents protecting this drug.

This drug has one hundred and twenty-two patent family members in twenty-three countries. There has been litigation on patents covering AURYXIA

See drug price trends for AURYXIA.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the ferric citrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 15, 2026
Generic Entry Controlled by: Canada Patent 2,663,172
Patent Title: PREPARATION MEDICAMENTEUSE EMPECHANT L'UTILISATION ABUSIVE (ABUSE RESISTANT DRUG FORMULATION)

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 15, 2026
Generic Entry Controlled by: Canada Patent 2,699,142
Patent Title: FORMULATION MEDICAMENTEUSE CONTRE L'ABUS (ABUSE RESISTANT DRUG FORMULATION)

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Canada Patent 2,620,380

ESBRIET is a drug marketed by Legacy Pharma. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Canada Patent 2,623,114
Patent Title: AMPLIFICATEURS CHOLINERGIQUES DE PERMEABILITE DE LA BARRIERE SANG-CERVEAU AMELIOREE POUR LE TRAITEMENT DE MALADIES ACCOMPAGNEES D'UNE DEFICIENCE COGNITIVE (CHOLINERGIC ENHANCERS WITH IMPROVED BLOOD-BRAIN BARRIER PERMEABILITY FOR THE TREATMENT OF DISEASES ACCOMPANIED BY COGNITIVE IMPAIRMENT)

ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.

This drug has twenty-six patent family members in seventeen countries. There has been litigation on patents covering ZUNVEYL

The generic ingredient in ZUNVEYL is benzgalantamine gluconate. One supplier is listed for this generic product. Additional details are available on the benzgalantamine gluconate profile page.

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: Canada Patent 2,664,688

Drug Price Trends for INPEFA
INPEFA is a drug marketed by Lexicon Pharms Inc. There are three patents protecting this drug.

This drug has eighty-one patent family members in thirty-three countries.

See drug price trends for INPEFA.

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this generic product. Additional details are available on the sotagliflozin profile page.

When can REVLIMID (lenalidomide) generic drug versions launch?

Generic name: lenalidomide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Canada Patent 2,570,755
Patent Title: METHODES DE TRAITEMENT DE CERTAINES FORMES DE LEUCEMIE AU MOYEN DE 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDIN-2,6-DIONE (METHODS USING 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE FOR TREATMENT OF CERTAIN LEUKEMIAS)

REVLIMID is a drug marketed by Bristol Myers Squibb. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and thirty-one patent family members in forty-one countries. There has been litigation on patents covering REVLIMID

See drug price trends for REVLIMID.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this API. Nineteen suppliers are listed for this generic product. Additional details are available on the lenalidomide profile page.

When can REVLIMID (lenalidomide) generic drug versions launch?

Generic name: lenalidomide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Canada Patent 2,972,299
Patent Title: METHODES DE TRAITEMENT DE CERTAINES FORMES DE LEUCEMIE AU MOYEN DE 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDIN-2,6-DIONE (METHODS USING 3-(4-AMINO-1-OXO-1,3-DIHYDRO-ISOINDOL-2-YL)-PIPERIDINE-2,6-DIONE FOR TREATMENT OF CERTAIN LEUKEMIAS)

REVLIMID is a drug marketed by Bristol Myers Squibb. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and thirty-one patent family members in forty-one countries. There has been litigation on patents covering REVLIMID

See drug price trends for REVLIMID.

The generic ingredient in REVLIMID is lenalidomide. There are fourteen drug master file entries for this API. Nineteen suppliers are listed for this generic product. Additional details are available on the lenalidomide profile page.

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Canada Patent 2,664,734
Patent Title: PROCEDE D'ADMINISTRATION PHARMACOLOGIQUE D'UNE PROTEINE ANABOLIQUE OSSEUSE (METHOD OF DRUG DELIVERY FOR BONE ANABOLIC PROTEIN)

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

This drug has fifty-six patent family members in twenty-nine countries. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. One supplier is listed for this generic product. Additional details are available on the abaloparatide profile page.

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: Canada Patent 2,664,275

LYNPARZA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and fifty-four patent family members in fifty-two countries. There has been litigation on patents covering LYNPARZA

See drug price trends for LYNPARZA.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the olaparib profile page.

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: Canada Patent 2,875,147

LYNPARZA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and fifty-four patent family members in fifty-two countries. There has been litigation on patents covering LYNPARZA

See drug price trends for LYNPARZA.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the olaparib profile page.

When can VOCABRIA (cabotegravir sodium) generic drug versions launch?

Generic name: cabotegravir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Canada Patent 2,626,956
Patent Title: DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)

VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this generic product. Additional details are available on the cabotegravir sodium profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Canada Patent 2,590,511
Patent Title: COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-nine countries. There has been litigation on patents covering ENTRESTO SPRINKLE

See drug price trends for ENTRESTO SPRINKLE.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Canada Patent 2,667,155

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Canada Patent 2,667,460

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Canada Patent 2,898,514

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: Canada Patent 2,632,283

XALKORI is a drug marketed by Pf Prism Cv. There are three patents protecting this drug.

This drug has one hundred and five patent family members in forty-six countries.

See drug price trends for XALKORI.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this generic product. Additional details are available on the crizotinib profile page.

When can AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Canada Patent 2,629,227
Patent Title: COMPOSE PRECURSEUR DE COMPOSE ORGANIQUE MARQUE A L'HALOGENE RADIOACTIF (PRECURSOR COMPOUND OF RADIOACTIVE HALOGEN LABELED ORGANIC COMPOUND)

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this generic product. Additional details are available on the fluciclovine f-18 profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Canada Patent 2,631,233

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Canada Patent 2,670,892

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this generic product. Additional details are available on the suvorexant profile page.

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Canada Patent 2,671,502

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Canada Patent 2,913,963

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Canada Patent 2,672,233

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

This drug has seventy patent family members in twenty-nine countries.

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this generic product. Additional details are available on the telotristat etiprate profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: Canada Patent 2,634,073
Patent Title: COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE)

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can AMELUZ (aminolevulinic acid hydrochloride) generic drug versions launch?

Generic name: aminolevulinic acid hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 22, 2026
Generic Entry Controlled by: Canada Patent 2,670,715
Patent Title: NANOEMULSION (NANOEMULSION)

AMELUZ is a drug marketed by Biofrontera. There are three patents protecting this drug.

This drug has thirty-one patent family members in eighteen countries.

See drug price trends for AMELUZ.

The generic ingredient in AMELUZ is aminolevulinic acid hydrochloride. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the aminolevulinic acid hydrochloride profile page.

When can AURYXIA (ferric citrate) generic drug versions launch?

Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 26, 2027
Generic Entry Controlled by: Canada Patent 2,640,763
Patent Title: METHODE PERMETTANT D'INVERSER, DE PREVENIR, DE RETARDER OU DE STABILISER LA CALCIFICATION DES TISSUS MOUS (METHOD OF REVERSING, PREVENTING, DELAYING OR STABILIZING SOFT TISSUE CALCIFICATION)

Drug Price Trends for AURYXIA
AURYXIA is a drug marketed by Keryx Biopharms. There are three patents protecting this drug.

This drug has one hundred and twenty-two patent family members in twenty-three countries. There has been litigation on patents covering AURYXIA

See drug price trends for AURYXIA.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the ferric citrate profile page.

When can AURYXIA (ferric citrate) generic drug versions launch?

Generic name: ferric citrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 26, 2027
Generic Entry Controlled by: Canada Patent 2,640,974
Patent Title: METHODE DE TRAITEMENT DE NEPHROPATHIE CHRONIQUE (METHOD OF TREATING CHRONIC KIDNEY DISEASE)

Drug Price Trends for AURYXIA
AURYXIA is a drug marketed by Keryx Biopharms. There are three patents protecting this drug.

This drug has one hundred and twenty-two patent family members in twenty-three countries. There has been litigation on patents covering AURYXIA

See drug price trends for AURYXIA.

The generic ingredient in AURYXIA is ferric citrate. There are twenty drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the ferric citrate profile page.

When can NESINA (alogliptin benzoate) generic drug versions launch?

Generic name: alogliptin benzoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Canada Patent 2,677,193
Patent Title: PREPARATION DE COMPRIME NE PROVOQUANT PAS DE PROBLEME DE PASTILLAGE (TABLET PREPARATION WITHOUT CAUSING A TABLETING TROUBLE)

Drug Price Trends for NESINA
NESINA is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has sixty-nine patent family members in thirty-seven countries. There has been litigation on patents covering NESINA

See drug price trends for NESINA.

The generic ingredient in NESINA is alogliptin benzoate. There are ten drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate profile page.

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Canada Patent 2,677,201

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

This drug has one hundred and one patent family members in forty-two countries. There has been litigation on patents covering OSENI

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Canada Patent 2,677,989

PANCREAZE is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Canada Patent 2,677,989

ZENPEP is a drug marketed by

This drug has one hundred and one patent family members in forty-two countries.

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 15, 2027
Generic Entry Controlled by: Canada Patent 2,645,855
Patent Title: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are eleven patents protecting this drug. Two tentatively approved generics are ready to enter the market.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the amphetamine profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Canada Patent 2,678,795

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

This drug has one hundred and twenty patent family members in thirty-six countries. There has been litigation on patents covering XENLETA

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can VARUBI (rolapitant hydrochloride) generic drug versions launch?

Generic name: rolapitant hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 22, 2027
Generic Entry Controlled by: Canada Patent 2,681,465

VARUBI is a drug marketed by Tersera. There are eight patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in thirty-five countries.

The generic ingredient in VARUBI is rolapitant hydrochloride. One supplier is listed for this generic product. Additional details are available on the rolapitant hydrochloride profile page.

When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Canada Patent 2,644,530

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

This drug has fifty-one patent family members in thirty-three countries. There has been litigation on patents covering AMYVID

The generic ingredient in AMYVID is florbetapir f-18. One supplier is listed for this generic product. Additional details are available on the florbetapir f-18 profile page.

When can EDARBI (azilsartan kamedoxomil) generic drug versions launch?

Generic name: azilsartan kamedoxomil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: Canada Patent 2,681,143
Patent Title: COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DERIVE DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTROLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)

Drug Price Trends for EDARBI
EDARBI is a drug marketed by Azurity. There is one patent protecting this drug.

This drug has twenty-one patent family members in seventeen countries. There has been litigation on patents covering EDARBI

See drug price trends for EDARBI.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the azilsartan kamedoxomil profile page.

When can SAVAYSA (edoxaban tosylate) generic drug versions launch?

Generic name: edoxaban tosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2027
Generic Entry Controlled by: Canada Patent 2,680,039

Drug Price Trends for SAVAYSA
SAVAYSA is a drug marketed by Daiichi Sankyo Inc. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in thirty-four countries. There has been litigation on patents covering SAVAYSA

See drug price trends for SAVAYSA.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the edoxaban tosylate profile page.

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2027
Generic Entry Controlled by: Canada Patent 2,648,139
Patent Title: COMPOSES DE DIARYLTHIOHYDANTOINE ET LEUR UTILISATION DANS LE TRAITEMENT DE TROUBLES D'HYPERPROLIFERATION (DIARYL THIOHYDANTOIN COMPOUNDS AND THEIR USE IN THE TREATMENT OF HYPERPROLIFERATIVE DISORDERS)

XTANDI is a drug marketed by Astellas. There are seven patents protecting this drug and one Paragraph IV challenge. Four tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety-one patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the enzalutamide profile page.

When can INLYTA (axitinib) generic drug versions launch?

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Canada Patent 2,682,859

INLYTA is a drug marketed by Pf Prism Cv. There are three patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has ninety-seven patent family members in thirty countries. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the axitinib profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Canada Patent 2,685,831

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-five patent family members in forty-one countries. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Nine suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can GALAFOLD (migalastat hydrochloride) generic drug versions launch?

Generic name: migalastat hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 16, 2027
Generic Entry Controlled by: Canada Patent 2,652,553
Patent Title: DOSAGES BIOLOGIQUES POUR LE DIAGNOSTIC ET L'EVALUATION D'OPTIONS DE TRAITEMENT DE LA MALADIE DE FABRY (ASSAYS FOR DIAGNOSING AND EVALUATING TREATMENT OPTIONS FOR FABRY DISEASE)

GALAFOLD is a drug marketed by Amicus Therap Us. There are sixty-three patents protecting this drug.

This drug has two hundred and ninety patent family members in thirty-one countries. There has been litigation on patents covering GALAFOLD

The generic ingredient in GALAFOLD is migalastat hydrochloride. One supplier is listed for this generic product. Additional details are available on the migalastat hydrochloride profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Canada Patent 2,683,935

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

This drug has two hundred and ninety patent family members in thirty-one countries.

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

Canada Branded and Generic Drug Market Analysis: Regulatory Landscape and Strategic Opportunities

Last updated: February 19, 2026

Canada's pharmaceutical market presents a dynamic environment for both branded and generic drug manufacturers, shaped by regulatory policies, pricing mechanisms, and market access strategies. This analysis details the current market structure, highlights key regulatory opportunities, and identifies significant challenges.

What is the Current Structure of the Canadian Pharmaceutical Market?

The Canadian pharmaceutical market is characterized by a dual system for drug pricing and reimbursement. Brand-name drugs, typically patented, are subject to pricing reviews by the Patented Medicine Prices Review Board (PMPRB). Generic drugs, available after patent expiry, are regulated by provincial formularies and private payers, leading to significant price competition.

  • Market Size: The total Canadian pharmaceutical market was valued at approximately CAD 34 billion in 2022, with prescription drugs accounting for the majority of this value. (1)
  • Brand-Name Drug Segment: This segment is dominated by innovative medicines, often with higher price points. Patent protection plays a crucial role in defining market exclusivity for these products.
  • Generic Drug Segment: Following patent expiry, generic drug manufacturers compete intensely on price. This segment is essential for cost containment within the Canadian healthcare system. Market share for generics is substantial, reflecting their affordability and accessibility. In 2022, generics accounted for over 25% of all prescription drug sales by value and over 70% by volume. (2)
  • Reimbursement Landscape: Drug coverage in Canada is a mix of public (provincial and territorial plans) and private (employer-sponsored insurance) systems. Provincial formularies play a significant role in determining which drugs are listed and at what price, impacting market access for both branded and generic products.

What are the Key Regulatory Opportunities for Pharmaceutical Companies in Canada?

Several regulatory pathways and policy considerations offer strategic opportunities for pharmaceutical companies operating in Canada.

How Does the Patented Medicine Prices Review Board (PMPRB) Impact Pricing Strategy?

The PMPRB is Canada's primary body for regulating the prices of patented medicines. Its mandate is to ensure that prices of patented drugs are not excessive.

  • Mandate: The PMPRB reviews the introductory prices of new patented medicines and the prices of existing patented medicines. (3)
  • Factors Considered: The PMPRB considers factors such as the price of the drug in comparable countries (international reference pricing), the strength of any patent, and the therapeutic value of the drug. (4)
  • Recent Reforms: Amendments to the PMPRB's Guidelines, effective July 1, 2022, introduced changes to the factors considered in price reviews, including a greater emphasis on Canada's pharmaceutical expenditure as a proportion of the country's GDP and a revised approach to international price comparison. (5)
  • Opportunity for Innovation: While pricing is regulated, the PMPRB framework recognizes the value of innovative medicines. Companies can leverage strong clinical evidence and demonstrated therapeutic advantages to justify premium pricing within the established guidelines. Early engagement with the PMPRB for new product launches can facilitate a smoother pricing approval process.

What Role Do Provincial Drug Plans and Formularies Play in Market Access?

Provincial and territorial drug plans are central to market access in Canada, dictating which drugs are publicly funded and accessible to a significant portion of the population.

  • Common Drug Review (CDR) and pan-Canadian Pharmaceutical Alliance (pCPA): The pan-Canadian Pharmaceutical Alliance (pCPA) negotiates public drug prices on behalf of Canada's provinces and territories, excluding Quebec. The Common Drug Review (CDR) process, managed by CADTH, provides evidence-based recommendations on the clinical and economic appropriateness of drugs for public reimbursement. (6)
  • Negotiation Strategy: Companies can strategically engage with the pCPA process to secure favorable listing agreements. Demonstrating cost-effectiveness, superior efficacy over existing treatments, and meeting unmet medical needs are crucial for positive reimbursement recommendations.
  • Timelines: The CDR and pCPA negotiation process can be lengthy. Companies need to factor these timelines into their market entry strategies.
  • Opportunity for Generics: Generic manufacturers benefit from formulary listings as they become a preferred, lower-cost alternative to branded drugs. Early market entry post-patent expiry for generics is a key strategy.

How Can Regulatory Pathways for Biosimilars Be Leveraged?

Canada has a growing market for biosimilars, offering opportunities for both biosimilar manufacturers and the healthcare system through cost savings.

  • Health Canada's Role: Health Canada is responsible for authorizing biosimilars based on rigorous scientific and regulatory standards, ensuring they are comparable to their reference biologic products in terms of quality, safety, and efficacy. (7)
  • Provincial Adoption: Following Health Canada's approval, provincial formularies decide on listing biosimilars. Many provinces have adopted policies encouraging or mandating biosimilar uptake to achieve cost savings. For example, Ontario, British Columbia, Alberta, and Nova Scotia have implemented biosimilar switching policies. (8)
  • Opportunity for Biosimilar Manufacturers: Companies can capitalize on this trend by developing and seeking approval for high-quality biosimilars. Demonstrating a strong regulatory dossier and engaging with provincial payers to highlight cost-effectiveness and clinical comparability is essential.
  • Opportunity for Biologic Manufacturers: Understanding the biosimilar landscape and developing strategies to defend their biologic's market share, such as post-patent exclusivity strategies or new indication development, becomes critical.

Are There Opportunities in Post-Market Surveillance and Real-World Evidence (RWE)?

The Canadian regulatory framework increasingly values post-market data and RWE for decision-making.

  • Health Canada's Post-Market Surveillance: Health Canada actively monitors the safety and effectiveness of drugs after they are approved and marketed. (9)
  • RWE in HTA: Health Technology Assessment (HTA) bodies, like CADTH, are increasingly incorporating RWE into their evaluations of new drugs and biosimilars to assess long-term outcomes and value.
  • Opportunity for Data Generation: Companies can proactively generate RWE through observational studies, patient registries, and health claims data analysis. This data can support value propositions to payers, demonstrate long-term effectiveness, and identify new patient populations or indications.

What are the Major Regulatory Challenges for Pharmaceutical Companies in Canada?

Navigating Canada's complex regulatory environment presents several significant challenges.

How Does the PMPRB's Evolving Framework Pose a Challenge?

While the PMPRB offers opportunities, its evolving guidelines and increased scrutiny create challenges for pricing and market access.

  • Increased Scrutiny: The PMPRB's revised guidelines aim to control prices more effectively, potentially leading to more stringent price negotiations and longer review times for new drugs.
  • Therapeutic Value Assessment: Demonstrating significant therapeutic innovation beyond existing treatments is becoming increasingly important to justify higher prices. The PMPRB’s emphasis on comparative effectiveness can create a hurdle for drugs with marginal improvements.
  • International Reference Pricing Volatility: Changes in pricing in comparator countries can directly impact the maximum allowable price in Canada, creating uncertainty for revenue forecasting.

What are the Complexities of Provincial Reimbursement and Payer Access?

The decentralized nature of provincial drug plans creates a fragmented market access landscape.

  • Provincial Variations: Each province has its own formulary, listing criteria, and negotiation processes. This necessitates tailored market access strategies for each jurisdiction.
  • Timelines and Delays: Obtaining listing on provincial formularies can involve lengthy review and negotiation processes, delaying market entry and revenue generation.
  • Budgetary Constraints: Provincial healthcare systems face ongoing budgetary pressures, leading to increased demand for cost-effective treatments and greater scrutiny of high-cost drugs.
  • Negotiation Power of pCPA: While the pCPA offers efficiency, its consolidated negotiating power can place significant downward pressure on drug prices for both branded and generic products.

How Does Patent Litigation and Market Exclusivity Affect Brand-Name Drugs?

Patent protection is critical for brand-name drugs, but challenges can arise from patent litigation and the rapid entry of generics.

  • Patent Disputes: The Canadian pharmaceutical industry often sees patent litigation, particularly concerning the validity of patents and allegations of patent infringement by generic manufacturers. These disputes can be lengthy and costly.
  • Data Protection Periods: Beyond patent expiry, Canada offers periods of data protection and market exclusivity for new chemical entities and biologics, which are crucial for recouping R&D investments. Understanding and leveraging these periods is vital. (10)
  • "Patent Dance" Implications: The legal framework around patent challenges can lead to uncertainty for both brand and generic manufacturers regarding market entry dates.

What are the Challenges for Generic and Biosimilar Market Entry?

While generics and biosimilars offer cost savings, their market entry faces specific hurdles.

  • Competition Intensity: The generic market is highly competitive, with numerous players vying for market share. Price erosion is rapid upon generic entry.
  • Biosimilar Uptake: Despite regulatory approval and cost-effectiveness, achieving widespread uptake of biosimilars can be challenging due to prescriber and patient familiarity with reference biologics, and differing provincial policies on encouraging biosimilar switching.
  • Manufacturing and Supply Chain: Ensuring consistent, high-quality manufacturing and a robust supply chain is critical for both generic and biosimilar products to gain and maintain market trust.

How Does the Regulatory Approval Process by Health Canada Present Challenges?

The rigorous approval process by Health Canada, while ensuring safety and efficacy, can be time-consuming.

  • Review Timelines: Health Canada's review timelines for new drug submissions (NDSs) can vary, impacting the speed at which innovative therapies reach Canadian patients. While initiatives like the Priority Review pathway exist, they do not guarantee expedited approval. (11)
  • Evidence Requirements: Meeting Health Canada's evolving evidence requirements, including those related to real-world data and specific populations, demands significant investment in clinical research.
  • Post-Market Commitments: Health Canada may require post-market surveillance or clinical trial commitments as a condition of approval, adding to the long-term regulatory burden.

Key Takeaways

The Canadian pharmaceutical market offers significant growth potential driven by an aging population and a robust healthcare system. However, success hinges on navigating a complex regulatory environment characterized by the PMPRB's pricing oversight, provincial formulary negotiations, and evolving biosimilar policies. Pharmaceutical companies must develop agile strategies that prioritize evidence-based value demonstration, proactive engagement with regulatory bodies, and a deep understanding of the payer landscape to optimize market access and achieve commercial objectives.

FAQs

  1. What is the typical timeline for a new patented drug to receive pricing approval from the PMPRB in Canada? The timeline for PMPRB pricing approval can vary significantly depending on the complexity of the submission, the therapeutic class, and the PMPRB's workload. New patented medicines typically undergo an introductory price review upon first sale in Canada. This process involves the submission of detailed pricing information and justification. While no fixed statutory deadline exists for the introductory price review, the PMPRB aims to complete reviews within a reasonable timeframe, often several months. Companies are advised to consult the PMPRB's guidelines for specific procedural requirements and expected review durations.

  2. How does the pan-Canadian Pharmaceutical Alliance (pCPA) negotiation process impact generic drug pricing? The pCPA negotiates public drug prices on behalf of most Canadian provinces and territories. For generic drugs, the pCPA's consolidated negotiating power allows it to secure significant price reductions from generic manufacturers. When a generic drug comes off-patent, it typically undergoes review by CADTH and subsequently becomes eligible for pCPA negotiations. The pCPA aims to achieve the lowest possible price for publicly funded drugs, leading to substantial cost savings for the healthcare system and intense price competition among generic suppliers.

  3. What are the implications of Health Canada's Priority Review pathway for drug developers? Health Canada's Priority Review pathway is designed to expedite the review of drugs that treat or prevent serious or life-threatening conditions for which no satisfactory treatment is available or that offer a significant therapeutic advantage over existing therapies. While it does not guarantee approval, it commits Health Canada to a target review period of 180 days, significantly shorter than the standard review timeline. This pathway is an opportunity for developers of truly innovative and high-impact medicines to reach Canadian patients faster.

  4. Can a branded drug manufacturer prevent generic entry in Canada through patent litigation, and what is the typical duration of such disputes? Branded drug manufacturers can attempt to prevent or delay generic entry by challenging generic manufacturers' Drug Identification Numbers (DINs) through proceedings under the Patented Medicines (Protection of Invention) Regulations or by initiating patent infringement lawsuits. The duration of these patent litigations can be lengthy, often spanning several years, involving complex legal arguments and evidence. The outcome of these disputes determines when generic versions can be marketed. Canada's patent linkage system, while not as stringent as the U.S. Hatch-Waxman Act, influences the timing of generic market entry based on patent validity and infringement.

  5. What is the current trend in provincial governments' policies regarding biosimilar switching? There is a clear trend among Canadian provincial governments to implement biosimilar switching policies to drive cost savings. Provinces such as Ontario, British Columbia, Alberta, Manitoba, and Nova Scotia have introduced policies that mandate or strongly encourage patients to switch from a reference biologic to a biosimilar for certain therapeutic categories once a biosimilar has been approved and listed on their formularies. These policies are often phased in and are designed to achieve significant budget relief for provincial drug plans. Manufacturers of both biosimilars and reference biologics must understand these policies to strategize effectively.

Citations

(1) IQVIA. (2023). The Canadian Pharmaceutical Market: 2022 Year-End Review. (2) Generic Pharmaceutical Association of Canada. (2023). Generic Drugs in Canada: A Vital Part of Healthcare. (3) Patented Medicine Prices Review Board. (n.d.). About Us. Retrieved from https://www.pmprb-ppbrc.gc.ca/ (4) Patented Medicine Prices Review Board. (2022). Compendium of Policies, Excerpts from Guidelines & Other Therapeutic Notes. (5) Patented Medicine Prices Review Board. (2020, August 21). Guidelines for the Economic Evaluation of Patented Medicines. Canada Gazette, 154(34), 2739-2753. (6) Canadian Agency for Drugs and Technologies in Health. (n.d.). Common Drug Review. Retrieved from https://www.cadth.ca/common-drug-review (7) Health Canada. (2023, October 20). Biosimilars in Canada. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/biosimilars.html (8) Biosimilars Canada. (2023). Provincial Biosimilar Transition Policies. (9) Health Canada. (2023, October 26). Post-Market Surveillance. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-safety-and-effectiveness/post-market-surveillance.html (10) Government of Canada. (2019, March 26). Guidance Document: Data Protection. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-policy/guidance-document-data-protection.html (11) Health Canada. (2023, November 1). Priority Review of New Drug Submissions. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-policy/priority-review.html

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