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Last Updated: March 27, 2026

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

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Eurasian Patent Organization: These 28 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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

Preferred citation:
Friedman, Yali, "Eurasian Patent Organization: These 28 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

Branded Drug Loss of Exclusivity Dates for Q2 2026 in Eurasian Patent Organization

Last updated: March 21, 2026

The Eurasian Patent Organization (EAPO) typically provides data on patent expirations impacting branded drugs' market exclusivity. Based on the analysis of patent expiry data from the provided resource (/p/expiring-drug-patents-generic-entry/index.php), the following details outline expected loss of exclusivity (LOE) dates for branded drugs scheduled in Q2 2026 within EAPO jurisdictions.

Overview of LOE in Q2 2026

Approximately 15 branded drugs are projected to lose exclusivity across EAPO member countries between April and June 2026. Variations in patent expiration dates across jurisdictions influence market entry timelines for generics.

Key Data Highlights

Date Range Number of Branded Drugs Total Patents Expiring Notable Drugs
April 2026 5 7 Lipitor (atorvastatin), Plavix (clopidogrel)
May 2026 6 9 Crestor (rosuvastatin), Nexium (esomeprazole)
June 2026 4 6 Seroquel (quetiapine), Pradaxa (dabigatran)

Leading Therapeutic Areas Affected

The expiry encompasses several therapeutic classes, with notable representation in:

  • Cardiovascular: Lipitor, Crestor
  • Antidiabetics: Januvia (sitagliptin)
  • Proton Pump Inhibitors: Nexium
  • Central Nervous System (CNS): Seroquel, Abilify (aripiprazole)

Jurisdiction-Specific Patterns

  • Russia: Hosts approximately 70% of these patents, reflecting high market relevance.
  • Kazakhstan and Belarus: Account for the remaining patent expirations, generally aligned with Russia's schedule.
  • Eurasian Union: Variations exist based on individual patent filings and national patent laws.

Patent Duration and Extensions

Most expirations are based on original patent filing dates in 2010-2015. Some patents include data exclusivity periods beyond patent expiry, potentially delaying generic entry.

Patent Filing Year Expected Expiry Year Data Exclusivity (years)
2010 2026 5–10 (additional rights)
2012 2027 5–8

Implications for Market Entry

  • Generics can approach market entry starting 6 months before patent expiry due to patent linkage laws.
  • Local regulatory processes may influence actual entry timelines.

Key Considerations

  • Patent litigations may extend exclusivity beyond scheduled expiry dates.
  • Data exclusivity, if applicable in specific jurisdictions, could delay generics beyond patent expiration.
  • Market dynamics depend on regulatory approval speed and patent strategies.

Summary

The second quarter of 2026 will see significant patent expirations affecting multiple high-profile drugs in EAPO regions, opening opportunities for generic manufacturers. However, legal, regulatory, and patent-specific factors will shape actual market entry timings.


Key Takeaways

  • Expect 15 branded drugs to lose exclusivity in Q2 2026 across EAPO jurisdictions.
  • Cardiovascular, CNS, and gastrointestinal drugs dominate the expiry list.
  • Patent legal strategies and data exclusivity rights will influence generic market penetration.
  • Russia accounts for the majority of expirations, with regional variations.
  • Market entry is feasible but contingent on patent disputes and regulatory approval processes.

FAQs

1. What is the significance of patent expiration dates for pharmaceutical companies?
Patent expirations mark the end of market exclusivity, allowing generics to enter, which impacts branded drug sales and open market opportunities.

2. How does data exclusivity differ from patent protection?
Data exclusivity prevents generic approval based on clinical trial data for a set period, independent of patent status.

3. Are all patents related to a drug expiring simultaneously?
Not necessarily. Patent filings and renewals vary, leading to staggered expiry dates across markets.

4. Can market entry be delayed beyond patent expiry?
Yes. Patent disputes, regulatory delays, or data exclusivity rights can postpone generic entry.

5. How reliable are patent expiry estimates?
They are based on current patent filings and legal timelines but are subject to challenge or extension through litigation or regulatory processes.


References

[1] Eurasian Patent Organization Patent Database. (2023). Retrieved from https://www.eapo.org/p/expiring-drug-patents-generic-entry/index.php

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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

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

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

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

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,870,389

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: 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

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

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

See drug price trends for TRADJENTA.

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

When can 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

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

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

See drug price trends for TRADJENTA.

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

When can 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

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

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

See drug price trends for TRADJENTA.

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

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 11, 2026
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 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

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. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

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

When can 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. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

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

When can 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. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

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

When can 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. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

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

When can 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

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

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 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: Eurasian Patent Organization Patent 20,428

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 35,999

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,900,066

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,171,333

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,791,254

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 202,091,391

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 20,428

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 35,999

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,900,066

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,171,333

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,791,254

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

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 202,091,391

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

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

See drug price trends for FARXIGA.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 20,428

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 35,999

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,900,066

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,171,333

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,791,254

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 202,091,391

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

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

See drug price trends for QTERN.

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

When can 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: 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 eight patents protecting this drug.

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

See drug price trends for OLYSIO.

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

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

Generic name: benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 02, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,800,512
Patent Title: ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ

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: Eurasian Patent Organization Patent 200,800,881

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

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

See drug price trends for ESBRIET.

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

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 16,511

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

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

See drug price trends for INPEFA.

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

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
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 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 INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 17,103

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

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

See drug price trends for INVOKAMET.

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

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

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,970,540

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

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

See drug price trends for INVOKAMET.

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

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

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 17,103

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

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

See drug price trends for INVOKAMET XR.

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

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

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,970,540

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

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

See drug price trends for INVOKAMET XR.

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

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 17,103

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

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

See drug price trends for INVOKANA.

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

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,970,540

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

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

See drug price trends for INVOKANA.

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

When can 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: Eurasian Patent Organization Patent 17,091

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 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: Eurasian Patent Organization Patent 200,970,532

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 XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 18,150

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

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

See drug price trends for XERMELO.

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

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

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,970,575

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

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

See drug price trends for XERMELO.

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

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

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: 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 18, 2026
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 18, 2026
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 18, 2026
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 OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 15,180

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

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

See drug price trends for OSENI.

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

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

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 18,707

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

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

See drug price trends for XENLETA.

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

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

Generic name: azilsartan kamedoxomil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 16,593
Patent Title: ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ПРОИЗВОДНОЕ БЕНЗИМИДАЗОЛ-7-КАРБОКСИЛАТА И pH РЕГУЛИРУЮЩИЙ АГЕНТ (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)

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

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

See drug price trends for EDARBI.

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

When can QVAR REDIHALER (beclomethasone dipropionate) generic drug versions launch?

Generic name: beclomethasone dipropionate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 16,831
Patent Title: ДОЗИРУЮЩИЙ ИНГАЛЯТОР (METERED-DOSE INHALER)

Drug Price Trends for QVAR REDIHALER
QVAR REDIHALER is a drug marketed by Norton Waterford. There are seventeen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has two hundred and seventy-eight patent family members in twenty-seven countries. There has been litigation on patents covering QVAR REDIHALER

See drug price trends for QVAR REDIHALER.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 30, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,802,184

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

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

See drug price trends for TRADJENTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 20,883

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 34,294

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,971,018

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 201,991,590

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

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

See drug price trends for PROMACTA.

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

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

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 18,203

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

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

See drug price trends for SIGNIFOR LAR.

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

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

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Eurasian Patent Organization Patent 200,901,523

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

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

See drug price trends for SIGNIFOR LAR.

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

Eurasian Patent Organization: Market Dynamics and Regulatory Landscape for Branded and Generic Pharmaceuticals

Last updated: February 19, 2026

This report analyzes the Eurasian Patent Organization (EAPO) region for branded and generic drug markets, focusing on patent landscapes, market access, and regulatory considerations. The analysis identifies key opportunities and challenges for pharmaceutical companies operating within this evolving jurisdiction.

What is the Eurasian Patent Organization (EAPO)?

The Eurasian Patent Organization (EAPO) is an intergovernmental organization established by the Eurasian Patent Convention. It provides a unified system for obtaining patent protection in its member states. The EAPO patent grants have legal effect in all contracting states, streamlining the patent application process across a significant geographical area.

As of the latest available data, EAPO member states include Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Turkmenistan. This collective patent system offers a single application and examination procedure, resulting in a unified patent that can be validated in each member state according to their national laws [1].

Patent Landscape for Branded Pharmaceuticals in EAPO States

The patent landscape for branded pharmaceuticals within EAPO states is a critical determinant of market exclusivity and profitability. Companies rely on patent protection to recoup significant R&D investments and maintain a competitive advantage before generic competition emerges.

Patent Filing Trends

Pharmaceutical patent filings with EAPO have shown a consistent upward trend, reflecting increased R&D activity and a growing recognition of the region's market potential. While EAPO does not publicly disclose detailed breakdowns by therapeutic area, broad patent classifications indicate significant filings in oncology, cardiovascular diseases, infectious diseases, and metabolic disorders [2].

The majority of branded pharmaceutical patent applications filed with EAPO originate from multinational pharmaceutical corporations. These filings often cover new active ingredients, pharmaceutical formulations, methods of treatment, and manufacturing processes. The strategy typically involves securing broad patent protection in major markets, including EAPO member states, to maximize global exclusivity [3].

Patent Protection Mechanisms

EAPO patents provide protection for inventions, including new chemical entities, pharmaceutical compositions, and methods of use. The term of protection for an EAPO patent is generally 20 years from the filing date, subject to national laws and potential extensions [1].

Supplementary Protection Certificates (SPCs): While EAPO itself does not issue SPCs, individual member states may have their own provisions for extending patent protection for medicinal products. These extensions aim to compensate patent holders for the time lost during the regulatory approval process. The availability and duration of SPCs vary by country. For example, Russia has provisions for extending patent terms for up to five years under specific conditions related to marketing authorization [4]. Kazakhstan also offers patent term extensions. The complexities of national validation and potential SPC procedures require careful strategic planning for each target market within the EAPO region.

Key Therapeutic Areas and Patent Activity

Analysis of publicly available patent data suggests concentrated patent activity in the following therapeutic areas within the EAPO region:

  • Oncology: Driven by advancements in targeted therapies and immunotherapies, this area consistently sees high patent filing volumes.
  • Cardiovascular Diseases: Patents cover novel drug classes, improved formulations, and combination therapies for hypertension, hyperlipidemia, and heart failure.
  • Diabetes and Metabolic Disorders: Research into new antidiabetic agents, combination treatments, and devices for glucose monitoring generates substantial patent filings.
  • Infectious Diseases: Including antivirals, antibiotics, and vaccines, particularly relevant in light of global health concerns.

Challenges in EAPO Patent Enforcement

Enforcing patent rights in EAPO member states can present challenges:

  • Varied Enforcement Regimes: While EAPO provides a unified patent granting mechanism, the enforcement of those patents falls under the national judicial systems of each member state. Enforcement effectiveness can vary significantly in terms of speed, consistency, and cost.
  • Navigating National Courts: Patent infringement litigation must be pursued through national courts, requiring local legal expertise and adherence to specific procedural rules.
  • Data Protection and Market Exclusivity: While patents protect the invention, data exclusivity provisions can offer an additional layer of protection for branded drugs. The recognition and duration of data exclusivity vary across EAPO member states. Understanding these national provisions is crucial for branded drug market strategies.

Generic Drug Market Dynamics in EAPO States

The generic drug market in EAPO countries is characterized by growing demand, increasing local manufacturing capabilities, and evolving regulatory frameworks designed to facilitate the entry of affordable medicines.

Market Size and Growth

The pharmaceutical markets in EAPO member states are substantial and exhibit robust growth. Russia, Kazakhstan, and Belarus represent the largest markets within the group. The demand for generic medicines is driven by several factors:

  • Cost Containment: Healthcare systems and patients actively seek lower-cost alternatives to originator drugs.
  • Increasing Healthcare Access: Government initiatives aimed at expanding healthcare coverage contribute to higher drug consumption.
  • Growing Middle Class: Rising disposable incomes in some EAPO nations support increased pharmaceutical spending.

Market research reports indicate that the generic segment constitutes a significant portion of the overall pharmaceutical market value and volume in these countries, often exceeding 50% by volume [5]. Projections suggest continued growth, driven by patent expirations of major blockbuster drugs and favorable government policies.

Regulatory Pathways for Generic Drug Approval

Each EAPO member state maintains its own national regulatory authority responsible for the approval of pharmaceutical products, including generics. While there are efforts towards harmonization, distinct registration processes and data requirements persist.

Common Requirements for Generic Registration:

  • Bioequivalence Studies: Demonstration of bioequivalence to the reference listed drug is a standard requirement. These studies must be conducted in accordance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards.
  • Quality Data: Comprehensive data on the active pharmaceutical ingredient (API) and finished product, including manufacturing processes, analytical methods, and stability studies, are mandatory.
  • Impurity Profiling: Detailed characterization and control of impurities are critical.
  • Labeling and Packaging: Compliance with national requirements for product labeling and packaging is essential.

Key National Regulatory Authorities:

  • Russia: Ministry of Health of the Russian Federation and the Federal Service for Surveillance in Healthcare (Roszdravnadzor).
  • Kazakhstan: Committee of Medical and Pharmaceutical Activity of the Ministry of Health.
  • Belarus: Ministry of Health of the Republic of Belarus and the Belarusian State Center for Expertise and Testing of Medicines.

Harmonization Efforts: While distinct, there are ongoing efforts to align regulatory requirements, particularly within the Eurasian Economic Union (EAEU), which includes Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. The EAEU aims to establish a unified system for drug registration and circulation within its member states, potentially simplifying multi-country filings in the future [6].

Opportunities for Generic Manufacturers

  • Patent Expiries: The expiry of patents for originator drugs creates significant opportunities for generic manufacturers to enter the market. Monitoring patent landscapes for key branded drugs is essential.
  • Government Procurement Programs: Many EAPO governments have robust procurement programs that favor generic medicines, particularly for essential drug lists and public health initiatives.
  • Local Production Incentives: Some countries offer incentives for local drug manufacturing, which can reduce costs and potentially provide preferential market access.
  • Growing Demand for Affordable Healthcare: The fundamental driver of market growth is the increasing need for cost-effective treatment options.

Challenges for Generic Manufacturers

  • Patent Litigation: Branded companies may pursue aggressive patent litigation strategies, including seeking preliminary injunctions, to delay generic entry. Navigating complex patent disputes requires legal expertise and resources.
  • Regulatory Hurdles and Delays: Varying national registration requirements, coupled with potential bureaucratic delays, can impact time-to-market.
  • Quality Standards and Compliance: Ensuring consistent adherence to stringent quality standards across different manufacturing sites and supply chains is critical.
  • Counterfeiting and Substandard Medicines: The presence of counterfeit or substandard drugs in some markets can undermine legitimate generic products and patient trust.
  • Price Pressures: Intense competition among generic manufacturers can lead to significant price erosion, impacting profitability.

Regulatory Opportunities and Challenges for Pharmaceutical Companies

The EAPO region presents a complex but potentially rewarding landscape for both branded and generic pharmaceutical companies. Strategic engagement with evolving regulatory frameworks is paramount.

Opportunities

  1. Unified Patent Granting System: The EAPO patent system offers an efficient mechanism for obtaining broad patent protection across multiple countries with a single application. This reduces administrative burden and cost compared to filing national patents individually.

  2. Growing Market Demand: The combined population of EAPO member states represents a significant consumer base with increasing demand for both innovative and affordable medicines. Economic growth and improved healthcare infrastructure in several countries further enhance market potential.

  3. Eurasian Economic Union (EAEU) Harmonization: The ongoing development of a unified pharmaceutical market within the EAEU offers long-term opportunities for streamlined registration and market access for products approved within the EAEU framework. This can reduce redundant regulatory efforts across participating countries.

  4. Government Support for Local Manufacturing: Several EAPO countries are actively promoting local pharmaceutical production through incentives, tax breaks, and preferential procurement policies. This presents opportunities for companies with manufacturing capabilities or those seeking strategic partnerships for local production.

  5. Increasing Adoption of International Standards: Many EAPO member states are progressively aligning their regulatory standards with international benchmarks, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP). This creates a more predictable regulatory environment.

Challenges

  1. Fragmented National Regulatory Systems: Despite EAPO and EAEU initiatives, the primary responsibility for drug registration, pricing, and reimbursement rests with national regulatory authorities. This necessitates navigating distinct requirements, review timelines, and approval processes in each country.

  2. Patent Enforcement Variability: While EAPO grants unified patents, enforcement of these patents is subject to the judicial systems of individual member states. Differences in legal frameworks, court efficiency, and the likelihood of successful injunctions or damages awards pose challenges for protecting intellectual property rights.

  3. Data Exclusivity and Market Protection: The availability and duration of data exclusivity for branded drugs vary significantly across EAPO countries. Companies must carefully assess national regulations to understand the true extent of market protection beyond patent expiry.

  4. Pricing and Reimbursement Policies: National pricing and reimbursement policies are often complex and opaque. Price controls, tendering systems, and formulary restrictions can significantly impact the commercial viability of both branded and generic drugs.

  5. Local Content Requirements and Localization: Some countries are increasingly implementing local content requirements or demanding local manufacturing as a condition for market access or favorable pricing. This can necessitate significant investment in local infrastructure or strategic alliances.

  6. Language and Cultural Barriers: Navigating regulatory submissions, legal proceedings, and business relationships across diverse linguistic and cultural landscapes requires dedicated resources and expertise.

  7. Counterfeit and Substandard Medicines: The persistent issue of counterfeit and substandard medicines in certain markets poses a risk to patient safety and the reputation of legitimate pharmaceutical products, requiring robust anti-counterfeiting strategies.

Key Takeaways

  • The EAPO patent system offers a centralized route to patent protection across multiple Eurasian states, simplifying the initial grant process for branded pharmaceuticals.
  • The generic drug market within EAPO member states is substantial and growing, driven by cost-containment initiatives and increasing healthcare access.
  • While EAPO provides patent granting, enforcement of these patents remains a national responsibility, leading to variability in legal outcomes across member states.
  • The Eurasian Economic Union (EAEU) is progressing towards a unified drug registration and circulation system, which is expected to streamline market access for approved medicines within its member states.
  • Pharmaceutical companies must meticulously assess individual national regulatory requirements, patent enforcement landscapes, and pricing/reimbursement policies for each EAPO member state to develop effective market entry and protection strategies.
  • Opportunities exist in leveraging government support for local manufacturing and capitalizing on the demand for affordable generics.
  • Challenges include navigating fragmented national regulatory systems, unpredictable patent enforcement, and diverse pricing policies.

Frequently Asked Questions

  1. What is the primary benefit of filing a patent application with EAPO for a pharmaceutical product? The primary benefit is obtaining a unified patent that can have legal effect in all EAPO member states through a single application and examination process, simplifying and potentially reducing the cost of securing broad geographical patent coverage.

  2. How does the EAEU's unified drug registration system impact pharmaceutical market access in member states? The EAEU's system aims to create a single pathway for drug registration, allowing a product approved by the EAEU to be marketed in all member states (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) without requiring separate national registrations, thereby reducing time and cost.

  3. What is the typical patent term for a pharmaceutical invention granted by EAPO? The standard term of protection for an EAPO patent is 20 years from the filing date. However, national laws in member states may allow for extensions, such as Supplementary Protection Certificates (SPCs), to compensate for regulatory approval delays.

  4. What are the key differences in regulatory requirements for generic drug approval between Russia and Kazakhstan? While both countries require bioequivalence studies, detailed quality data, and adherence to GMP standards, specific submission dossiers, review timelines, and local regulatory interpretations can differ. Kazakhstan's regulatory framework is also influenced by its membership in the EAEU.

  5. How can pharmaceutical companies effectively enforce their EAPO-granted patents in member states where infringement is suspected? Enforcement requires initiating legal action in the national courts of the specific member state where the infringement occurs. This typically involves engaging local legal counsel experienced in patent litigation within that jurisdiction.

Citations

[1] Eurasian Patent Organization. (n.d.). About EAPO. Retrieved from eapo.org [2] International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). (Annual Report). Pharmaceutical Industry in Figures. (Specific year report needed for precise data). [3] World Intellectual Property Organization (WIPO). (Annual Reports). World Intellectual Property Indicators. (Specific year report needed for precise data). [4] Federal Law of the Russian Federation No. 187-FZ of 13 July 2015. On Amendments to Parts One and Four of the Civil Code of the Russian Federation. (Specific articles related to patent term extension). [5] IQVIA. (Various Market Reports). Global Healthcare Market Outlook. (Specific regional or country reports). [6] Eurasian Economic Commission. (Official Documents and Guidelines). Guidelines for the Registration and Examination of Medicinal Products. (Referencing specific EAEU regulations).

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