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

Russian Federation: These 15 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Russian Federation: These 15 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 KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Russian Federation Patent 2,008,129,199
Patent Title: НОВАЯ ГИДРОСУЛЬФАТНАЯ СОЛЬ

KOSELUGO is a drug marketed by Astrazeneca. There are eight patents protecting this drug.

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

See drug price trends for KOSELUGO.

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

When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Russian Federation Patent 2,418,790
Patent Title: НОВАЯ ГИДРОСУЛЬФАТНАЯ СОЛЬ (NOVEL HYDROSULPHATE SALT)

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,129,201
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ПОВЫШЕННОЙ СТАБИЛЬНОСТЬЮ

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

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

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

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: Russian Federation Patent 2,427,383
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ПОВЫШЕННОЙ СТАБИЛЬНОСТЬЮ (HIGH STABILITY PHARMACEUTICAL COMPOSITIONS)

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

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Russian Federation Patent 2,435,569
Patent Title: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)

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

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

See drug price trends for TUZISTRA XR.

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

When can OZEMPIC (semaglutide) generic drug versions launch?

Generic name: semaglutide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2026
Generic Entry Controlled by: Russian Federation Patent 2,007,134,156
Patent Title: АЦИЛИРОВАННЫЕ GLP-1 СОЕДИНЕНИЯ

OZEMPIC is a drug marketed by Novo. There are nineteen patents protecting this drug.

This drug has two hundred and thirty-eight patent family members in thirty-three countries. There has been litigation on patents covering OZEMPIC

See drug price trends for OZEMPIC.

The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this generic product. Additional details are available on the semaglutide profile page.

When can WEGOVY (semaglutide) generic drug versions launch?

WEGOVY is a drug marketed by Novo. There are nine patents protecting this drug.

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

See drug price trends for WEGOVY.

The generic ingredient in WEGOVY is semaglutide. Two suppliers are listed for this generic product. Additional details are available on the semaglutide profile page.

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

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Russian Federation Patent 2,445,077
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ (PHARMACEUTICAL COMPOSITIONS)

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

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

See drug price trends for EMBEDA.

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

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

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,101,971

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

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

See drug price trends for TEKTURNA HCT.

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

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,104,949
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

EPIDUO FORTE is a drug marketed by Galderma Labs.

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

See drug price trends for EPIDUO FORTE.

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

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

Generic name: menthol; methyl salicylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,144,958
Patent Title: АДГЕЗИВНЫЙ ПРЕПАРАТ

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

This drug has twenty patent family members in sixteen countries.

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

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

Generic name: menthol; methyl salicylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Russian Federation Patent 2,441,649
Patent Title: АДГЕЗИВНЫЙ ПРЕПАРАТ (ADHESIVE PRODUCT)

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,109,651
Patent Title: ЯДРА МИКРОПЕЛЛЕТ ПАНКРЕАТИНА, ПРИГОДНЫЕ ДЛЯ НАНЕСЕНИЯ ЭНТЕРОСОЛЮБИЛЬНОГО ПОКРЫТИЯ

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Russian Federation Patent 2,440,101
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ РЕГУЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ НЕСТАБИЛЬНЫХ В КИСЛОЙ СРЕДЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ (CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS UNSTABLE IN MEDICINAL ACID MEDIUM)

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

Generic name: sacubitril; valsartan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Russian Federation Patent 2,007,123,671
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОИЕНЗИНА И ИНГИБИТОРА NEP

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

See drug price trends for ENTRESTO SPRINKLE.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Russian Federation Patent 2,503,668
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSIN RECEPTOR ANTAGONIST AND NEP INHIBITOR)

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

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,121,297
Patent Title: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ

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

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

See drug price trends for KORSUVA.

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

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

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,121,298
Patent Title: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ

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

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Russian Federation Patent 2,510,399
Patent Title: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ И ИХ ДИМЕРЫ (SYNTHETIC PEPTIDE AMIDES AND THEIR DIMERS)

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,120,338

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

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

See drug price trends for XALKORI.

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

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: Russian Federation Patent 2,387,650

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

Generic name: fluciclovine f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Russian Federation Patent 2,428,415
Patent Title: СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ (RADIOACTIVE HALOGEN-LABELLED ORGANIC COMPOUND PRECURSOR)

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

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

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

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,126,147

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

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

See drug price trends for BEVYXXA.

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

Last updated: July 27, 2025

Introduction

Russia's pharmaceutical market ranks among the world's largest, driven by a rapidly growing healthcare sector, government reforms, and an aging population. Consisting of both branded (innovator) and generic drugs, the sector offers expansive opportunities amid complex regulatory landscapes. Navigating these dynamics requires understanding local market characteristics, evolution of regulatory frameworks, and the interplay between intellectual property (IP) rights, pricing policies, and market access strategies.

Market Overview

The Russian pharmaceutical market reached approximately USD 20 billion in 2022, with an annual growth rate of 3-5% (1). Branded drugs, primarily global and domestic innovator products, dominate high-margin segments such as oncology, cardiology, and neurology. Meanwhile, generics constitute over 70% of the dispensed prescriptions, reflecting government policies aimed at reducing healthcare costs and increasing drug accessibility (2).

Market Segmentation

Branded Drugs: Comprise innovative treatments, vaccines, and specialty medications, often embedded with intellectual property rights, higher prices, and longer market exclusivity.
Generic Drugs: Offer cost-effective therapeutic alternatives post-patent expiry, accounting for a significant share of prescriptions amid Russian healthcare reimbursement policies favoring generics.

Regulatory Framework: Opportunities and Challenges

1. Intellectual Property Rights and Patent Protections

Russia's adherence to the TRIPS Agreement and its evolving patent laws shape the innovator landscape.

Opportunities: Increased patent protections, including patent extensions and data exclusivity, incentivize R&D investments and indirect support for branded drugs.
Challenges: A history of patent loopholes, such as compulsory licensing and patent challenges, complicates the exclusivity period for innovator products. These provisions enable local manufacturers to produce generics before patent expiry, diminishing profit margins for branded drugs (3).

2. Clinical Trials and Registration Procedures

Russia has reformed its drug registration processes to streamline approvals, aligning with Eurasian Economic Union (EAEU) standards.

Opportunities: The post-approval registration period has shortened, encouraging timely market entry for both branded and generic drugs, especially if companies participate in local clinical trials.
Challenges: Local clinical trial requirements remain complex and costly, with strict adverse event reporting and quality standards creating barriers for foreign manufacturers. Delays or rejections can hamper timely lancement.

3. Pricing and Reimbursement Policies

Price controls and reimbursement mechanisms heavily influence market dynamics.

Opportunities: Recent policies promote biosimilars and generics to reduce public healthcare expenditure, opening avenues for cost-effective drugs.
Challenges: Price caps and reference pricing policies limit revenue potential for branded drugs, especially when local tenders favor low-cost generics. Manufacturers must negotiate reimbursement terms carefully.

4. Imports and Manufacturing Regulations

The 'Made in Russia' policy encourages local production to bolster self-sufficiency.

Opportunities: Incentives for local manufacturing, such as tax benefits and simplified registration for domestically produced drugs, offer strategic advantages.
Challenges: Stringent quality standards, localization requirements, and restrictions on imports pose hurdles for foreign companies seeking market access, requiring substantial capital investment.

5. Distribution and Pharmacovigilance

Effective distribution channels and robust pharmacovigilance systems are mandated by regulation.

Opportunities: Digital health initiatives and centralized databases improve oversight and compliance, facilitating market penetration.
Challenges: Fragmented distribution networks and variability in pharmacovigilance compliance can hinder consistent market operations.

Regulatory Opportunities

Expanding Use of Biosimilars: With a government push for biosimilar adoption to cut costs, manufacturers of biologics can capitalize on regulatory pathways designed for such products, including simplified registration procedures.
Participation in State Procurement: The Russian government actively promotes local manufacturers through preferential procurement, creating opportunities for branded and generic drugs aligned with national standards.
Adoption of Eurasian Conformity (EAC): Harmonized standards across the EAEU facilitate regional market entry, offering broader access within member states.

Regulatory Challenges

Complex Registration Procedures: Navigating Russia's centralized registration process demands local legal and regulatory expertise, with potential delays impacting time-to-market.
Patent Litigation Risks: Local courts have historically been receptive to patent challenges, risking patent infringement disputes that could delay or block product launches.
Pricing Constraints: Price regulation and mandatory discounts reduce profit margins, especially for high-cost innovator drugs.
Market Entry Barriers: Localization requirements and import restrictions heightened by political and trade policies increase entry complexity and costs for foreign manufacturers.

Strategic Outlook

Foreign companies must develop robust compliance strategies balancing IP rights, local regulatory requirements, and market incentives. Forming partnerships with local entities, investing in clinical trials, and tailoring product portfolios to the evolving regulatory environment present optimal pathways for success. Recognizing the importance of government tenders and aligning with national drug development priorities can unlock significant opportunities.

Key Takeaways

The Russian pharmaceutical sector offers considerable growth potential but is characterized by a complex regulatory environment that favors local manufacturing and cost-effective generics.
Patents play a pivotal role; however, legal challenges and compulsory licensing provisions can undermine exclusivity for innovative drugs.
Market access hinges on navigating registration processes, pricing regulations, and localization policies.
Opportunities arise in biosimilar development and regional integration via the Eurasian Economic Union.
Success demands strategic partnerships, local clinical data, and compliance with evolving standards to mitigate regulatory risks and capitalize on government incentives.

FAQs

1. How does Russia's patent law impact innovator pharmaceutical products?
Russia’s patent regulations have historically allowed for patent challenges and compulsory licensing, which can compromise exclusivity. Recent reforms, aligned with WTO standards, strengthen patent protections, but legal ambiguities remain, necessitating proactive IP management.

2. What regulatory pathways are available for biosimilars in Russia?
Regulatory pathways for biosimilars are established through the Ministry of Health’s guidelines, emphasizing similarity to reference biologics validated via local or international clinical data. Streamlined registration processes incentivize biosimilar development.

3. Are foreign pharmaceutical companies encouraged to enter the Russian market?
Yes. Despite regulatory hurdles, Russia offers promising opportunities, especially with government support for local manufacturing and regional integration. Success depends on compliance with local standards and strategic partnerships.

4. How do government pricing policies affect branded versus generic drugs?
Pricing regulations impose caps and mandatory discounts, reducing margins for branded drugs while favoring cheaper generics. Manufacturers need adaptive pricing strategies aligned with reimbursement policies.

5. What role do import restrictions play in market strategy?
Import restrictions, including localization requirements and tariffs, motivate foreign firms to establish local manufacturing or joint ventures, enhancing market presence but increasing initial investment barriers.

References

IQVIA. Russia Pharmaceutical Market Report 2022.
Russian Ministry of Health. Federal Program on Pharmaceuticals and Medical Devices.
WIPO. Patent Laws and Pharmaceutical Patent Rights in Russia.

Introduction

Market Overview

Market Segmentation

Regulatory Framework: Opportunities and Challenges

1. Intellectual Property Rights and Patent Protections

2. Clinical Trials and Registration Procedures

3. Pricing and Reimbursement Policies

4. Imports and Manufacturing Regulations

5. Distribution and Pharmacovigilance

Regulatory Opportunities

Regulatory Challenges

Strategic Outlook

Key Takeaways

FAQs

References

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