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Last Updated: April 25, 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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Eurasian Patent Organization: These 16 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Eurasian Patent Organization: These 16 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 BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 18,982
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ (PHARMACEUTICAL COMPOSITIONS COMPRISING HDAC (HISTONE DEACETYLASE) INHIBITORS)

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

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

See drug price trends for BELEODAQ.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 23,400
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ (PHARMACEUTICAL FORMULATIONS COMPRISING HISTONE DEACETYLASE INHIBITORS)

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

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

See drug price trends for BELEODAQ.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,702,467
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ

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

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

See drug price trends for BELEODAQ.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,370,122
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ ИНГИБИТОРЫ ДЕАЦЕТИЛАЗЫ ГИСТОНОВ

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

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

See drug price trends for BELEODAQ.

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

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

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 03, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 14,528
Patent Title: СОСТАВЫ, СОДЕРЖАЩИЕ ПЕПТИДЫ, СТИМУЛИРУЮЩИЕ РЕЦЕПТОР ЭРИТРОПОЭТИНА И ИХ ПРИМЕНЕНИЕ (ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES)

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

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

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

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

Generic name: peginesatide acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 03, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,702,656
Patent Title: СОСТАВЫ, СОДЕРЖАЩИЕ ПЕПТИДЫ, СТИМУЛИРУЮЩИЕ РЕЦЕПТОР ЭРИТРОПОЭТИНА, И ИХ ПРИМЕНЕНИЕ

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

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

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

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 15,131
Patent Title: МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С (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 29, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,800,476
Patent Title: МАКРОЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ВИРУСА ГЕПАТИТА С

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, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 15,815
Patent Title: ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)

EPSOLAY is a drug marketed by Galderma Labs Lp. There are eleven patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has forty-five patent family members in thirteen countries.

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. One supplier is 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, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,800,512
Patent Title: ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ

EPSOLAY is a drug marketed by Galderma Labs Lp. There are eleven patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has forty-five patent family members in thirteen countries.

See drug price trends for EPSOLAY.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this API. One supplier is 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, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 30,093
Patent Title: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)

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-four 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-three 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, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,800,881
Patent Title: ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ

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-four 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-three suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 12,377
Patent Title: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-five suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,800,931
Patent Title: ТВЁРДЫЕ ПЕРОРАЛЬНЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ОДИН РАЗ В СУТКИ, СОДЕРЖАЩИЕ ПРЕГАБАЛИН, МАТРИЦЕОБРАЗУЮЩИЙ АГЕНТ И АГЕНТ НАБУХАНИЯ

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-five suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 17,290
Patent Title: КОМПОЗИЦИИ НА ОСНОВЕ ГАНАКСОЛОНА (GANAXOLONE-BASED FORMULATIONS)

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

This drug has forty-five patent family members in sixteen countries.

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 ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,801,468
Patent Title: ПРЕПАРАТЫ ГАНАКСОЛОНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ

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

This drug has forty-five patent family members in sixteen countries.

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 PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 18,545
Patent Title: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ (THERAPEUTIC COMPOSITIONS)

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 PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 24,152
Patent Title: КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ВВЕДЕНИЯ ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ РАКА КОЖИ (TOPICAL COMPOSITION FOR TREATING OR PREVENTING SKIN CANCER)

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 PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,870,063
Patent Title: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ

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 PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 16, 2025
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,201,452
Patent Title: ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ

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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 25,483
Patent Title: ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ СЕЗОННОГО ГРИППА (INTRAVENOUS METHOD FOR TREATING A SEASONAL INFLUENZA)

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

This drug has forty-two 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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,870,263
Patent Title: ВНУТРИВЕННЫЙ СПОСОБ ЛЕЧЕНИЯ ВИРУСНОЙ ИНФЕКЦИИ

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

This drug has forty-two 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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,870,430
Patent Title: ВНУТРИМЫШЕЧНЫЕ АНТИВИРУСНЫЕ СПОСОБЫ ЛЕЧЕНИЯ

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

This drug has forty-two 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 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: Eurasian Patent Organization Patent 14,716
Patent Title: α-КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ (α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)

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 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: Eurasian Patent Organization Patent 200,801,777
Patent Title: α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЁ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ ЕЁ СОДЕРЖАТ

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 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: Eurasian Patent Organization Patent 17,898
Patent Title: СТИРИЛПИРИДИНОВЫЕ ПРОИЗВОДНЫЕ И ИХ ПРИМЕНЕНИЕ ДЛЯ СВЯЗЫВАНИЯ И ВИЗУАЛИЗАЦИИ АМИЛОИДНЫХ БЛЯШЕК (STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)

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.

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: Eurasian Patent Organization Patent 200,870,389
Patent Title: СТИРИЛПИРИДИНОВЫЕ ПРОИЗВОДНЫЕ И ИХ ПРИМЕНЕНИЕ ДЛЯ СВЯЗЫВАНИЯ И ВИЗУАЛИЗАЦИИ АМИЛОИДНЫХ БЛЯШЕК

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.

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: Eurasian Patent Organization Patent 16,221
Patent Title: ОФТАЛЬМИЧЕСКИЕ КОМПОЗИЦИИ И СПОСОБ ЛЕЧЕНИЯ АЛЛЕРГИЧЕСКИХ ЗАБОЛЕВАНИЙ ГЛАЗ (OPHTHALMIC COMPOSITIONS AND METHOD OF TREATING OCULAR ALLERGIES)

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: Eurasian Patent Organization Patent 200,870,396
Patent Title: ЛЕЧЕНИЕ АЛЛЕРГИЧЕСКИХ ЗАБОЛЕВАНИЙ ГЛАЗ

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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 16,559
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV (DPP IV INHIBITOR FORMULATIONS)

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

This drug has four hundred and sixty-two 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: Eurasian Patent Organization Patent 29,890
Patent Title: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ В ПЕРОРАЛЬНОЙ ДОЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЕ НА ОСНОВЕ ИНГИБИТОРА DPP IV (PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL COMPOSITION IN ORAL DOSAGE FORM BASED ON DPP IV INHIBITOR)

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

This drug has four hundred and sixty-two 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: Eurasian Patent Organization Patent 200,802,184
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV

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

This drug has four hundred and sixty-two 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: Eurasian Patent Organization Patent 201,100,958
Patent Title: ФАРМАЦЕВТИЧЕСКАЯ ПЕРОРАЛЬНАЯ ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА НА ОСНОВЕ ИНГИБИТОРОВ DPP IV

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

This drug has four hundred and sixty-two 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 FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 17,984
Patent Title: КРИСТАЛЛИЧЕСКИЕ БЕЗВОДНЫЕ ФОРМЫ ЛАКТАТА N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-АКРИЛАМИДА (CRYSTALLINE WATER-FREE FORMS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE LACTATE)

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

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

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,802,383
Patent Title: ПОЛИМОРФНЫЕ ФОРМЫ N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-АКРИЛАМИДА

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

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

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate 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: Eurasian Patent Organization Patent 15,287
Patent Title: 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИН В КАЧЕСТВЕ СОЕДИНЕНИЯ С СОЧЕТАНИЕМ АКТИВНОСТИ В ОТНОШЕНИИ ПОВТОРНОГО ЗАХВАТА СЕРОТОНИНА, 5-НТИ 5-НТДЛЯ ЛЕЧЕНИЯ КОГНИТИВНОГО НАРУШЕНИЯ (1- [2- (2, 4-DIMETHYLPHENYLSULFANYL) -PHENYL] PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HTAND 5-HTACTIVITY 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 sixteen 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 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: Eurasian Patent Organization Patent 17,058
Patent Title: НОВОЕ ТЕРАПЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИНА (NOVEL THERAPEUTIC USES OF 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)PHENYL]PIPERAZINE)

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 sixteen 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 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: Eurasian Patent Organization Patent 200,970,018
Patent Title: 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИН В КАЧЕСТВЕ СОЕДИНЕНИЯ С СОЧЕТАНИЕМ АКТИВНОСТИ В ОТНОШЕНИИ ПОВТОРНОГО ЗАХВАТА СЕРОТОНИНА, 5-НТ3 И 5-НТ1А ДЛЯ ЛЕЧЕНИЯ КОГНИТИВНОГО НАРУШЕНИЯ

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 sixteen 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 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: Eurasian Patent Organization Patent 200,970,870
Patent Title: НОВОЕ ТЕРАПЕВТИЧЕСКОЕ ПРИМЕНЕНИЕ 1-[2-(2,4-ДИМЕТИЛФЕНИЛСУЛЬФАНИЛ)ФЕНИЛ]ПИПЕРАЗИНА

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 sixteen 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 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: Eurasian Patent Organization Patent 17,123
Patent Title: СПОСОБ ПОЛУЧЕНИЯ 2-[4-(3- И 2-ФТОРБЕНЗИЛОКСИ)БЕНЗИЛАМИНО]ПРОПАНАМИДОВ (PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDES)

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: Eurasian Patent Organization Patent 25,326
Patent Title: ПРИМЕНЕНИЕ САФИНАМИДА И РАЛФИНАМИДА ВЫСОКОЙ СТЕПЕНИ ЧИСТОТЫ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ И БОЛЕЗНЕННЫХ СОСТОЯНИЙ В УСЛОВИЯХ, НЕ ПРЕПЯТСТВУЮЩИХ АКТИВНОСТИ ЦИТОХРОМОВ СИСТЕМЫ CYP450 И НЕ ПРОЯВЛЯЮЩИХ БЛОКИРУЮЩИХ СВОЙСТВ В ОТНОШЕНИИ HERG КАНАЛА (USE OF HIGHLY PURE SAFINAMIDE AND RALFINAMIDE FOR TREATMENT OF DISEASES AND DISEASED STATES IN CONDITIONS THAT DO NOT SUPPRESS ACTIVITY OF CYP450 SYSTEM CYTOCHROMES AND DO NOT MANIFEST BLOCKING PROPERTIES IN RESPECT OF HERG CHANNEL)

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: Eurasian Patent Organization Patent 200,970,028
Patent Title: СПОСОБ ПОЛУЧЕНИЯ 2-[4-(3- И 2-ФТОРБЕНЗИЛОКСИ)БЕНЗИЛАМИНО]ПРОПАНАМИДОВ

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: Eurasian Patent Organization Patent 201,101,308
Patent Title: ПРИМЕНЕНИЕ РАЛФИНАМИДА ДЛЯ ЛЕЧЕНИЯ БИПОЛЯРНОГО РАССТРОЙСТВА

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.

Market Analysis and Financial Projection

The Eurasian Patent Organization (EAPO) has introduced significant regulatory changes impacting both branded and generic drug markets across its eight member states (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Azerbaijan). Below is an analysis of market dynamics, regulatory opportunities, and challenges:


EAPO Pharmaceutical Register: Key Features

Launched in March 2021, the EAPO Pharmaceutical Register serves as a centralized database for patents covering active pharmaceutical ingredients (APIs), formulations, production methods, and medical uses[1][7][16]. Key details include:

  • Coverage: Over 100 INNs (International Nonproprietary Names) at launch, linked to 286 Eurasian patents as of December 2021[7].
  • Data fields: Patent validity, supplementary protection certificates (SPCs), marketing authorizations, and license agreements[1][16].
  • Purpose: Simplifies freedom-to-operate (FTO) searches for generics and strengthens patent enforcement for innovators[9][16].

Impact on Branded Drug Markets

Opportunities

  1. Enhanced Patent Visibility: Patent holders gain a streamlined mechanism to list patents, reducing infringement risks and simplifying litigation[1][9].
  2. Market Exclusivity: The Register links patents to INNs, aiding in extending exclusivity periods and SPC management[7][16].
  3. Licensing Facilitation: Publicly accessible license agreement data encourages partnerships and technology transfers[1].

Challenges

  1. Non-Binding Status: The Register lacks formal integration with national drug approval systems, limiting its enforceability[9][16].
  2. Validation Costs: In Russia, separate patent validation by Rospatent incurs additional expenses for innovators[9].

Impact on Generic Drug Markets

Opportunities

  1. FTO Clarity: Generics can identify patent expiration dates and avoid infringement during development[16].
  2. Post-Patent Market Entry: Register data enables faster launches post-patent expiry, leveraging EAEU’s harmonized drug registration rules[7][10].
  3. Cost Savings: Reduced legal disputes lower barriers to entry, aligning with global trends where generics cost 80–85% less than branded drugs[3][10].

Challenges

  1. Patent Linkage Risks: Potential misuse of patent clusters or litigation tactics to delay generic entry, a tactic observed in other regions[6][17].
  2. Regulatory Fragmentation: Varying national enforcement mechanisms within EAPO member states create compliance complexities[11][14].

Regulatory Opportunities

  1. EAEU Harmonization: Since 2020, drug registration under EAEU common rules could align with the Register to reduce regional disparities[7].
  2. Real-World Data Integration: Expanded access programs (EAPs) could leverage Register data to support post-marketing surveillance and RWE collection[4][5].
  3. SPC Management: Centralized tracking of SPCs aids in predicting market entry timelines for generics[1].

Regulatory Challenges

  1. Cross-Border Enforcement: Lack of unified enforcement mechanisms complicates multi-jurisdictional patent disputes[11][14].
  2. Transparency Gaps: Limited public access to drug registration timelines and patent challenges delays generics[6].
  3. Resource Allocation: Smaller generic manufacturers face hurdles in navigating complex regulatory requirements across eight jurisdictions[10][13].

Comparative Insights

Aspect Branded Drug Market Generic Drug Market
Patent Visibility Strengthened via Register[1][16] Improved FTO analysis[9][16]
Market Entry Barriers Lower litigation risks[9] High due to regulatory complexity[6][10]
Cost Dynamics High R&D costs offset by exclusivity[3][10] 80–85% lower prices drive adoption[3][13]

Future Prospects

  • Convergence with Global Systems: Adopting features from the US Orange Book (e.g., patent-drug linkage) could enhance the Register’s utility[1][16].
  • AI-Driven Analytics: Integrating AI for patent lifecycle predictions could benefit both innovators and generics[10][13].

"The EAPO Register will certainly lower the burden of proof for patent holders in infringement cases." – Kluwer Patent Blog[1].


Key Takeaways

  1. The EAPO Pharmaceutical Register improves patent transparency but requires stronger regulatory integration.
  2. Generic markets benefit from FTO clarity but face fragmented enforcement.
  3. Harmonization under EAEU rules presents a critical growth opportunity.

FAQs

  1. Does the EAPO Register prevent generic drug approvals?
    No—it is informational and not legally binding on regulatory authorities[9].

  2. How does the Register compare to the US Orange Book?
    It focuses on patents rather than therapeutic equivalence but shares similar transparency goals[1][16].

  3. Can generics challenge patents via the Register?
    Third-party observations are permitted, but challenges remain jurisdiction-specific[7].

  4. What data do innovators submit for inclusion?
    INN-linked patent claims, marketing authorizations, and license agreements[1][16].

  5. Are there fees for Register submissions?
    No—applications are free, but national validations (e.g., in Russia) may incur costs[9].

References

  1. https://patentblog.kluweriplaw.com/2021/03/09/eurasian-union-pharmaceutical-register-launched/
  2. https://files.ontario.ca/moh-drug-submission-ontario-guidelines-transitioning-generics-eap-formulary-2023-08-30.pdf
  3. https://www.europarl.europa.eu/RegData/etudes/STUD/2023/753166/EPRS_STU(2023)753166_EN.pdf
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC4763516/
  5. https://www.dlrcgroup.com/expanded-access-programs-regulatory-strategy-for-compassionate-use/
  6. https://www.cofece.mx/wp-content/uploads/2017/11/Studies-drug-markets_vF-BAJA.pdf
  7. https://www.wipo.int/edocs/mdocs/scp/en/scp_33/scp_33_d_health.pdf
  8. https://www.youtube.com/watch?v=p8ILoMgXKwI
  9. https://rouse.com/insights/news/2021/the-eurasian-patent-office-has-launched-a-pharmaceutical-register
  10. https://www.stellarmr.com/report/Generic-Drug-Market/1638
  11. https://eulawenforcement.com/?p=8459
  12. https://www.paulhastings.com/insights/client-alerts/ex-parte-european-bank-account-freezing-order-now-available-in-eu-member-states-what-banks-and-their-clients-should-know
  13. https://www.biospace.com/u-s-generic-drugs-market-size-to-surpass-usd-188-44-bn-by-2032
  14. https://conflictoflaws.net/2025/conference-report-european-account-preservation-order-practical-challenges-and-prospects-for-reform-university-of-luxembourg-3-december-2024/
  15. https://www.uspharmacist.com/article/directions-in-generic-drugs
  16. https://ficpi.org/ip-news/eurasian-patent-office-launches-its-pharmaceutical-register
  17. https://haiweb.org/encyclopaedia/generic-competition/

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