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Last Updated: January 19, 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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European Patent Office: These 55 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "European Patent Office: These 55 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.
When can AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: European Patent Office Patent 1,978,944
Patent Title: FORMULATION DE CAPSULE GELATINEUSE MOLLE (SOFT-GELATIN CAPSULE FORMULATION)

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries. There has been litigation on patents covering AMITIZA

See drug price trends for AMITIZA.

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

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: European Patent Office Patent 1,989,214
Patent Title: PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS)

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Eighteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: European Patent Office Patent 2,581,381
Patent Title: Procédé de préparation d'un agoniste du récepteur A2A-adénosine et ses polymorphes (Process for preparing an A2A-adenosine receptor agonist and its polymorphs)

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Eighteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: European Patent Office Patent 1,986,626
Patent Title: TRAITEMENTS ANTIVIRAUX INTRAVEINEUX (INTRAVENOUS ANTIVIRAL TREATMENTS)

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can MACRILEN (macimorelin acetate) generic drug versions launch?

Generic name: macimorelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 18, 2026
Generic Entry Controlled by: European Patent Office Patent 1,984,744

MACRILEN is a drug marketed by Novo. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

See drug price trends for MACRILEN.

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

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: European Patent Office Patent 1,989,182

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

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

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: European Patent Office Patent 2,018,160
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 DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: European Patent Office Patent 2,428,205
Patent Title: Formulations à libération modifiée contenant des complexes médicament - résine échangeuse 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 TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: European Patent Office Patent 2,428,205
Patent Title: Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

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

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex 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 30, 2026
Generic Entry Controlled by: European Patent Office Patent 1,999,109

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: European Patent Office Patent 2,363,391

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: European Patent Office Patent 2,363,392

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 LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: European Patent Office Patent 2,004,196
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 LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: European Patent Office Patent 3,150,209
Patent Title: TRAITEMENTS D'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 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: European Patent Office Patent 1,871,347
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: European Patent Office Patent 2,319,836
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 eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred 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 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: European Patent Office Patent 2,010,189
Patent Title: DISPOSITIF OSMOTIQUE D'ADMINISTRATION D'UN MÉDICAMENT COMPRENANT UN PROMOTEUR DE LA LIBÉRATION (OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT)

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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: European Patent Office Patent 1,852,108

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

This drug has four hundred and eighty-seven patent family members in forty-five 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,023,902

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

This drug has four hundred and eighty-seven patent family members in forty-five 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,277,509

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

This drug has four hundred and eighty-seven patent family members in forty-five 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,283,819

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

This drug has four hundred and eighty-seven patent family members in forty-five 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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: European Patent Office Patent 2,073,795
Patent Title: PRÉPARATION MÉDICAMENTEUSE EMPÊCHANT 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: June 15, 2026
Generic Entry Controlled by: European Patent Office Patent 2,200,593
Patent Title: FORMULATION MÉDICAMENTEUSE 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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: European Patent Office Patent 2,692,341
Patent Title: Préparation médicamenteuse empêchant 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 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: European Patent Office Patent 2,044,043
Patent Title: 1-[2-(2, 4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE COMME COMPOSE PRESENTANT UNE ACTIVITE SUR LA SEROTONINE, 5-HT3 ET 5-HT1A POUR LE TRAITEMENT DU DEFICIT COGNITIF (1- Ý[- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT)

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. Two 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: European Patent Office Patent 2,484,346

EMBEDA is a drug marketed by Alpharma Pharms. There are nine 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 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: European Patent Office Patent 2,526,932

EMBEDA is a drug marketed by Alpharma Pharms. There are nine 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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: European Patent Office Patent 2,029,524

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

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

See drug price trends for XADAGO.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the safinamide mesylate profile page.

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: European Patent Office Patent 2,474,521

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

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

See drug price trends for XADAGO.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the safinamide mesylate 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: European Patent Office Patent 2,034,968

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 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: European Patent Office Patent 2,311,439

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 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: European Patent Office Patent 3,391,878

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 VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 2,044,005
Patent Title: INHIBITEURS DE LA PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 2,327,696
Patent Title: Inhibiteurs de la prolyl hydroxylase et procédés d'utilisation (Prolyl hydroxylase inhibitors and methods of use)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 3,026,044
Patent Title: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 3,323,807
Patent Title: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 3,357,911
Patent Title: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: European Patent Office Patent 4,095,127
Patent Title: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this generic product. Additional details are available on the vadadustat 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: European Patent Office Patent 2,037,893

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

This drug has two hundred and sixty-one patent family members in forty-eight 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 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: European Patent Office Patent 2,069,374

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

This drug has three hundred and forty-six 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: European Patent Office Patent 2,457,918

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

This drug has three hundred and forty-six 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: European Patent Office Patent 3,045,466

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

This drug has three hundred and forty-six 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: European Patent Office Patent 3,363,807

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

This drug has three hundred and forty-six 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: European Patent Office Patent 2,069,374

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

This drug has four hundred and fifty-nine 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: European Patent Office Patent 2,457,918

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

This drug has four hundred and fifty-nine 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: European Patent Office Patent 3,045,466

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

This drug has four hundred and fifty-nine 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: European Patent Office Patent 3,363,807

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

This drug has four hundred and fifty-nine 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: European Patent Office Patent 2,069,374

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

This drug has three hundred and thirteen 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. One supplier is listed for this generic product. 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: European Patent Office Patent 2,457,918

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

This drug has three hundred and thirteen 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. One supplier is listed for this generic product. 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: European Patent Office Patent 3,045,466

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

This drug has three hundred and thirteen 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. One supplier is listed for this generic product. 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: European Patent Office Patent 3,363,807

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

This drug has three hundred and thirteen 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. One supplier is listed for this generic product. 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: European Patent Office Patent 2,046,318

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

This drug has sixty-eight patent family members in twenty-five 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. Thirteen suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide 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: European Patent Office Patent 2,450,035

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

This drug has sixty-eight patent family members in twenty-five 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. Thirteen 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: European Patent Office Patent 2,046,318

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

This drug has sixty-eight patent family members in twenty-five 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. Thirteen 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: European Patent Office Patent 2,450,035

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

This drug has sixty-eight patent family members in twenty-five 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. Thirteen 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: European Patent Office Patent 2,046,332

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: European Patent Office Patent 2,322,516
Patent Title: Composés intermédiaires pour la préparation d'inhibiteurs macrocycliques du virus de l'hépatite C (Intermediates for the preparation of Macrocyclic inhibitors of hepatitis c virus)

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

This drug has one hundred and forty patent family members in forty-three 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 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: European Patent Office Patent 2,937,339
Patent Title: Inhibiteurs macrocycliques du virus de l'hépatite C (Macrocylic inhibitors of hepatitis c virus)

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

This drug has one hundred and forty patent family members in forty-three 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: European Patent Office Patent 1,919,606
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 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: European Patent Office Patent 2,431,088
Patent Title: Revêtement d'oxyde métallique d'ingrédients insolubles dans l'eau (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 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: European Patent Office Patent 2,431,089
Patent Title: Revêtement d'oxyde métallique d'ingrédients insolubles dans l'eau (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 BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: European Patent Office Patent 2,056,832

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

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

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-five suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: European Patent Office Patent 2,059,246

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

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

See drug price trends for OPSUMIT.

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

When can OPSYNVI (macitentan; tadalafil) generic drug versions launch?

Generic name: macitentan; tadalafil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: European Patent Office Patent 2,059,246

OPSYNVI is a drug marketed by Actelion. There are three patents protecting this drug.

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

See drug price trends for OPSYNVI.

The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan; tadalafil 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: European Patent Office Patent 1,940,364

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 ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: European Patent Office Patent 2,431,025

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: European Patent Office Patent 1,940,817
Patent Title: AMPLIFICATEURS CHOLINERGIQUES DE PERMÉABILITÉ DE LA BARRIÈRE SANG-CERVEAU AMÉLIORÉE POUR LE TRAITEMENT DE MALADIES ACCOMPAGNÉES D'UNE DÉFICIENCE 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 CRESEMBA (isavuconazonium sulfate) generic drug versions launch?

Generic name: isavuconazonium sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 25, 2026
Generic Entry Controlled by: European Patent Office Patent 1,902,708
Patent Title: Compositions pharmaceutiques stabilisées et solides contenant au moins un médicament et procédé d'élaboration (Drug comprising stabilized pharmaceutical solid compositions and processes for their preparation)

Drug Price Trends for CRESEMBA
CRESEMBA is a drug marketed by Astellas. There are three patents protecting this drug.

This drug has thirty-two patent family members in nineteen countries. There has been litigation on patents covering CRESEMBA

See drug price trends for CRESEMBA.

The generic ingredient in CRESEMBA is isavuconazonium sulfate. One supplier is listed for this generic product. Additional details are available on the isavuconazonium sulfate 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: European Patent Office Patent 2,089,361

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. Additional details are available on the sotagliflozin 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: European Patent Office Patent 2,308,841

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. Additional details are available on the sotagliflozin 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: European Patent Office Patent 2,064,189

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: European Patent Office Patent 2,824,098

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 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: European Patent Office Patent 1,978,015
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: European Patent Office Patent 1,959,966
Patent Title: FORMES GALÉNIQUES DE GANAXOLONE ET PROCÉDÉS DE PREPARATION ET D'UTILISATION DE CELLES-CI (GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF)

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: European Patent Office Patent 2,089,382

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 BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: European Patent Office Patent 2,392,572

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 INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,102,224

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are five patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,102,224

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are four patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,102,224

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are four patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for INVOKANA.

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

When can ZUBSOLV (buprenorphine hydrochloride; naloxone hydrochloride) generic drug versions launch?

Generic name: buprenorphine hydrochloride; naloxone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: European Patent Office Patent 2,101,740
Patent Title: NOUVELLE COMPOSITION PHARMACEUTIQUE NON SUSCEPTIBLE D'ABUS COMPRENANT DES OPIOÏDES (NEW NON-ABUSABLE PHARMACEUTICAL COMPOSITION COMPRISING OPIOIDS)

Drug Price Trends for ZUBSOLV
ZUBSOLV is a drug marketed by Orexo Us Inc. There are ten patents protecting this drug and four Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

This drug has sixty-two patent family members in thirty-two countries. There has been litigation on patents covering ZUBSOLV

See drug price trends for ZUBSOLV.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: European Patent Office Patent 2,086,940

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

This drug has ninety-seven patent family members in thirty-nine countries.

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the bedaquiline fumarate 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: European Patent Office Patent 2,101,760
Patent Title: FORMULATIONS DE DOSES UNITAIRES ET PROCÉDÉS DE TRAITEMENT D'UNE THROMBOSE AVEC UN INHIBITEUR ORAL DU FACTEUR XA (UNIT DOSE FORMULATIONS AND METHODS OF TREATING THROMBOSIS WITH AN ORAL FACTOR XA INHIBITOR)

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 LETAIRIS (ambrisentan) generic drug versions launch?

Generic name: ambrisentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: European Patent Office Patent 2,101,777
Patent Title: COMPOSITION DE TRAITEMENT DE L'HYPERTENSION PULMONAIRE (COMPOSITION FOR TREATING A PULMONARY HYPERTENSION)

LETAIRIS is a drug marketed by Gilead. There are three patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for LETAIRIS.

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the ambrisentan profile page.

When can LETAIRIS (ambrisentan) generic drug versions launch?

Generic name: ambrisentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: European Patent Office Patent 2,952,193
Patent Title: COMPOSITION DE TRAITEMENT DE L'HYPERTENSION PULMONAIRE (COMPOSITION FOR TREATING A PULMONARY HYPERTENSION)

LETAIRIS is a drug marketed by Gilead. There are three patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for LETAIRIS.

The generic ingredient in LETAIRIS is ambrisentan. There are nine drug master file entries for this API. Thirteen suppliers are listed for this generic product. Additional details are available on the ambrisentan 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: European Patent Office Patent 2,091,940

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 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: European Patent Office Patent 2,589,600

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 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: European Patent Office Patent 3,176,159

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 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: European Patent Office Patent 3,808,740

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: European Patent Office Patent 2,399,571
Patent Title: Compositions thérapeutiques comprenant de l'ingénol-2-angelate (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 VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: European Patent Office Patent 1,968,601
Patent Title: SELS D'OUVREURS DES CANAUX POTASSIQUES ATP-DÉPENDANTS ET LEURS UTILISATIONS (SALTS OF POTASSIUM ATP CHANNEL OPENERS AND USES THEREOF)

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

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

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

When can VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: European Patent Office Patent 2,404,604
Patent Title: Sels d'ouverture de canal ATP du potassium et leurs utilisations (Salts of potassium ATP channel openers and uses thereof)

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

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

The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline 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: European Patent Office Patent 1,938,801
Patent Title: Nanoémulsion (Nanoemulsion)

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

This drug has twenty-nine 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 CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 16, 2027
Generic Entry Controlled by: European Patent Office Patent 1,984,009
Patent Title: COMPOSITIONS PHARMACEUTIQUES A STABILITE AMELIOREE (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY)

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate 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: European Patent Office Patent 2,079,445

PANCREAZE is a drug marketed by

This drug has thirty-nine patent family members in nineteen 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. One supplier is 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: European Patent Office Patent 2,079,445

ZENPEP is a drug marketed by

This drug has thirty-nine patent family members in nineteen 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. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can KERENDIA (finerenone) generic drug versions launch?

Generic name: finerenone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2027
Generic Entry Controlled by: European Patent Office Patent 2,132,206

Drug Price Trends for KERENDIA
KERENDIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug.

This drug has ninety-seven patent family members in forty-nine countries. There has been litigation on patents covering KERENDIA

See drug price trends for KERENDIA.

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

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 15, 2027
Generic Entry Controlled by: European Patent Office Patent 2,018,160
Patent Title: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

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

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

European Patent Office Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges

Last updated: December 27, 2025

Executive Summary

The European pharmaceutical market, distinguished by a robust branded drug sector alongside an expanding generic drug segment, presents significant opportunities amid complex regulatory landscapes. The European Patent Office (EPO) plays a pivotal role by granting patents that underpin innovative drug development, yet the transition from branded to generic markets involves navigating intricate patent law, European Medicines Agency (EMA) regulations, and market access hurdles. This comprehensive assessment explores the current market dynamics, the regulatory framework influencing drug approvals, and the opportunities and challenges facing pharmaceutical stakeholders in Europe.

  • The European pharmaceutical market is valued at approximately €200 billion in 2022, with generics accounting for over 40% of volume but only around 20% of value.
  • Patent expirations, notably post-2020, have opened windows for generic entrants, intensifying competition.
  • The EPO grants patents typically lasting 20 years, providing exclusivity that influences market timelines and entry strategies.
  • Regulatory pathways, including the EMA's centralized procedures, impact timing and approval certainty.
  • Challenges include patent litigation, pricing pressures, and evolving regulatory requirements; opportunities lie in biosimilars and innovative drug collaborations.

This piece elaborates on the intertwined roles of patent protections, regulatory pathways, market strategies, and their impacts on stakeholders aiming to optimize opportunities within Europe's diverse drug landscape.


What Is the Role of the European Patent Office in Drug Innovation and Market Exclusivity?

Patent System Overview in Europe

The EPO grants patents that serve as the foundational legal justification for exclusivity, incentivizing R&D investments:

Patent Aspect Details Relevance to Drugs
Duration 20 years from filing (registrations extend via supplementary protection certificates (SPCs) up to 5 additional years) Extends market exclusivity beyond initial patent term in Europe
Patent Types Invention patents, SPCs Protect active pharmaceutical ingredients, formulations, methods
Patent Filing Process Substantive examination, opposition Ensures patent quality and strategic positioning in markets

Impact on Branded Drug Development

  • Patents incentivize innovation by safeguarding novel molecules and formulations.
  • Patent protections determine key launch timelines and influence R&D investments.

Patent Expiry and Its Market Implication

  • Revenue peaks for branded drugs occur pre-expiry, after which generic competition erodes market share.
  • The EPO’s patent lifecycle management affects timing of biosimilar and generic entrants.

Assessment of the European Branded Drug Market

Market Size and Composition

Segment 2022 Estimates Key Insights
Total Market Value €200 billion Growing at approximately 3% annually
Branded Drugs Share ~60% of sales (€120 billion) Dominated by biotech and specialty drugs
Patent Protection Impact Critical for market dominance Patent expirations stimulate generics

Key Drivers

  • Increasing prevalence of chronic diseases (e.g., oncology, cardiovascular).
  • Rise of biologics and orphan drugs.
  • Investment in R&D to sustain patent portfolios amid patent cliffs.

Challenges

  • Patent litigations delaying market entry of generics.
  • Pricing pressures from healthcare payers.
  • Regulatory delays impacting launch timelines.

Assessment of the European Generic Drug Market

Market Dynamics

Statistic Details Significance
Market Volume Share Over 40% of units sold Lower price points incentivize substitution
Market Value Share ~20% of total value Margins are thinner compared to branded drugs
Top Generics by Revenue Simvastatin, Omeprazole, Atorvastatin Highly prescribed, mature segments

Market Growth Factors

  • Patent expiries of major drugs (e.g., Humira, Keytruda).
  • Policy shifts favoring generic substitution.
  • Regulatory approvals streamlined via centralized procedures.

Challenges

  • Price erosion leading to reduced profit margins.
  • Patent litigations and "patent evergreening" tactics.
  • Limited innovation in traditional generics space; focus on biosimilars for differentiation.

Regulatory Opportunities and Challenges in Europe

The EMA and Centralized Approval Pathways

Regulatory Pathway Description Impact on Market Entry
Centralized Procedure EMA approval for all EU member states Faster access, uniform standards
Mutual Recognition National agencies recognize approval decisions Flexibility, potential delays
Scientific Advice Early engagement with EMA on development Risk mitigation, smoother approvals

Opportunities from Regulatory Framework

  • Accelerated approval pathways for orphan drugs, biosimilars.
  • Use of real-world evidence (RWE) and adaptive licensing.
  • Alignment with international standards, facilitating export.

Challenges in Regulation

  • Strict requirements for biosimilars, including interchangeability.
  • Complex patent linkage and data exclusivity policies.
  • Divergence in national reimbursement policies affecting market access.

Market Entry Strategies for Branded and Generic Companies

Branded Sector

Strategy Focus Areas Challenges
Patent Portfolio Management Filing new patents, SPC extensions High R&D costs, patent litigation risks
Strategic Alliances Collaborations with biotech firms, licensing agreements Regulatory navigation, IP management
Market Segmentation Focus on orphan and specialty drugs High unmet needs and regulatory hurdles

Generic Sector

Strategy Focus Areas Challenges
Developing Biosimilars Biologics complex generics Technical complexity, regulatory hurdles
Cost-efficient Production Scale-up manufacturing, supply chain optimization Market saturation, pricing competition
Patent Litigations Defensive strategies against patent infringements Legal costs, settlement risks

Opportunities and Challenges Overview

Aspect Opportunities Challenges
Patent Expirations Entry into established markets, increased market share Patent litigation, market saturation
Biosimilar Development High growth potential, government incentives Technical complexity, regulatory approval hurdles
Policy Improvements Faster approvals, harmonized standards Stringent requirements, evolving policies
Market Expansion New therapeutic areas, unmet medical needs Competitive landscape, reimbursement policies

Deep Dive: Comparative Analysis of Patent Laws and Market Access

Parameter European Patent Law US Patent Law
Patent Term 20 years, extendable via SPCs 20 years, no SPC equivalent
Data Exclusivity 8+2+1 years for new drugs Often 5 years, longer for biologics
Patent Litigation Post-grant opposition, centralized review Patent Trial and Appeal Board (PTAB)
Regulatory Linkage Patent status influences marketing authorization timeline Less direct link, but patent litigation impacts market entry

Key Differences Relevant to Market Strategy

  • Europe's SPC system extends market exclusivity, influencing competition timelines.
  • Data exclusivity periods provide additional barriers to generics.
  • Litigation and opposition processes can delay or prevent market entry.

Future Outlook and Emerging Trends

Trend Implication Expected Impact
Rise of Biosimilars Increased competition in biologic markets Lower prices, expanded patient access
Digital Health Integration Precision medicine, personalized therapy Innovation opportunities, regulatory evolution
Policy Reform Harmonization efforts, pricing reforms Market stabilization, opportunities for innovation

Key Takeaways

  • The EPO’s patent framework is fundamental in safeguarding innovation but also shapes market dynamics, especially during patent cliffs.
  • Branded drug revenues are increasingly under pressure from patent expiries; strategic patent management and pipeline diversification are vital.
  • The expanding generic and biosimilar markets offer growth potential but are contested arenas requiring robust regulatory and legal strategies.
  • Regulatory pathways, including EMA central procedures and data exclusivity policies, significantly influence the timing and success of market entry.
  • Future growth hinges on biosimilar development, navigating complex patent landscapes, and leveraging policy reforms.

Frequently Asked Questions (FAQs)

1. How does the EPO’s patent system influence market exclusivity for drugs in Europe?
The EPO grants patents for up to 20 years, with extensions via supplementary protection certificates (SPCs) for up to five additional years. These patents delay generic entry, allowing branded drug companies to recoup R&D investments. As patents expire, the opportunity for generics increases, but patent litigation and opposition can extend or compromise exclusivity.

2. What are the main regulatory pathways for launching generic and biosimilar drugs in Europe?
Generic drugs typically utilize the decentralized or centralized EMA approval processes, with pathways requiring bioequivalence data. Biosimilars require demonstrating similarity to reference biologics, with specific EMA guidelines for interchangeability and extrapolation, often making their approval process more complex than small-molecule generics.

3. What challenges do companies face when introducing biosimilars in Europe?
Biosimilars face hurdles including complex manufacturing processes, demonstrating clinical similarity, establishing interchangeability standards, and navigating evolving EMA regulations. Additionally, healthcare systems may restrict substitution policies, impacting market uptake.

4. How are patent litigations and opposition procedures managed within the EU?
Post-grant opposition periods of nine months allow third parties to challenge patents. Patent litigation can occur in national courts or via specialized procedures. Managing these legal avenues is critical to defend patents or clear the path for generic entry.

5. What policy reforms could impact drug market dynamics in Europe?
Potential reforms include harmonization of pricing and reimbursement policies, adjustments to data exclusivity periods, and streamlined regulatory procedures for biosimilars. These reforms aim to foster innovation while promoting competition and affordability.


References

[1] European Patent Office (EPO). “Patent Law and Practice.” 2022.
[2] European Medicines Agency (EMA). “Guidelines on Similar Biological Medicines.” 2021.
[3] IQVIA. “European Pharmaceutical Market Reports.” 2022.
[4] European Commission. “Pharmaceutical Sector Policy and Market Dynamics.” 2021.
[5] Deloitte. “Biosimilars in Europe: Policy and Market Outlook.” 2022.


This report provides an in-depth, strategic perspective for pharmaceutical professionals evaluating opportunities and addressing challenges in Europe's branded and generic drug sectors, with an emphasis on patent and regulatory landscapes.

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