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Last Updated: December 28, 2025

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 29 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "European Patent Office: These 29 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 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 VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 05, 2026
Generic Entry Controlled by: European Patent Office Patent 3,545,958
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 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 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 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-six 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. Three 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-six 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. Three 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-six 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. Three 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-six 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. Three suppliers are listed for this generic product. Additional details are available on the linagliptin 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 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 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 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 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 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 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 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. Four 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 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 Genentech Inc. 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 Genentech Inc. 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 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 2,374,800

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 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 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 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 2,120,872
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.

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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