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 21 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Russian Federation: These 21 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.

When can TYMLOS (abaloparatide) generic drug versions launch in the Russian Federation?

Generic name: abaloparatide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,116,531
Patent Title: СПОСОБ ЛЕЧЕНИЯ ОСТЕОПОРОЗА И ИСПОЛЬЗУЕМАЯ В НЕМ КОМПОЗИЦИЯ (METHOD OF TREATING OSTEOPOROSIS AND COMPOSITION USED THEREIN)

TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. Additional details are available on the abaloparatide profile page.

When can TYMLOS (abaloparatide) generic drug versions launch in the Russian Federation?

Generic name: abaloparatide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Russian Federation Patent 2,506,070
Patent Title: СПОСОБ ЛЕЧЕНИЯ ОСТЕОПОРОЗА И ИСПОЛЬЗУЕМАЯ В НЕМ КОМПОЗИЦИЯ (METHOD OF TREATING OSTEOPOROSIS AND COMPOSITION USED THEREIN)

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,121,807

INREBIC is a drug marketed by Bristol-myers. There are five patents protecting this drug. There has been litigation on patents covering INREBIC

See drug price trends for INREBIC.

The generic ingredient in INREBIC is fedratinib hydrochloride. Additional details are available on the fedratinib hydrochloride profile page.

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,103,850

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,103,851

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,448,959

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,589,878

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in the Russian Federation?

Generic name: fedratinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,597,364
Patent Title: БИ-АРИЛ-МЕТА-ПИРИМИДИНОВЫЕ ИНГИБИТОРЫ КИНАЗ (BI-ARYL-META-PYRIMIDINE KINASE INHIBITORS)

When can BEVYXXA (betrixaban) generic drug versions launch in the Russian Federation?

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

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

When can BEVYXXA (betrixaban) generic drug versions launch in the Russian Federation?

Generic name: betrixaban
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2026
Generic Entry Controlled by: Russian Federation Patent 2,440,986
Patent Title: СОЛЬ ИНГИБИТОРА ФАКТОРА Ха, СПОСОБ ЕЕ ПОЛУЧЕНИЯ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ, СОСТОЯЩИЕ ИЗ НАЗВАННОЙ КОМПОЗИЦИИ ТАБЛЕТКА, КАПСУЛА И ЛЕПЕШКА, СПОСОБ ЛЕЧЕНИЯ ТРОМБОЗА И СПОСОБ ИНГИБИРОВАНИЯ КОАГУЛЯЦИИ ОБРАЗЦОВ КРОВИ (FACTOR Xa INHIBITOR SALT, METHOD FOR MAKING IT, BASED PHARMACEUTICAL COMPOSITION, TABLET, CAPSULE AND LOZENGE CONSISTING OF THIS COMPOSITION, METHOD FOR TREATING THROMBOSIS AND METHOD FOR INHIBITING BLOOD SAMPLE COAGULATION)

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch in the Russian Federation?

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 three patents protecting this drug. 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. Additional details are available on the sacubitril; valsartan profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch in the Russian Federation?

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 in the Russian Federation?

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 (SYNTHETIC PEPTIDE AMIDES)

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch in the Russian Federation?

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 (SYNTHETIC PEPTIDE AMIDES AND THEIR DIMERS)

When can KORSUVA (difelikefalin acetate) generic drug versions launch in the Russian Federation?

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Russian Federation Patent 2,500,685
Patent Title: СИНТЕТИЧЕСКИЕ ПЕПТИДНЫЕ АМИДЫ (SYNTHETIC PEPTIDE AMIDES)

When can KORSUVA (difelikefalin acetate) generic drug versions launch in the Russian Federation?

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 AXUMIN (fluciclovine f-18) generic drug versions launch in the Russian Federation?

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. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. Additional details are available on the fluciclovine f-18 profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch in the Russian Federation?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Russian Federation Patent 2,009,135,038
Patent Title: СТАБИЛЬНЫЕ КОМПОЗИЦИИ ПИЩЕВАРИТЕЛЬНЫХ ФЕРМЕНТОВ (STABLE COMPOSITIONS OF DIGESTIVE ENZYMES)

PANCREAZE is a drug marketed by

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch in the Russian Federation?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Russian Federation Patent 2,445,952
Patent Title: СТАБИЛЬНЫЕ КОМПОЗИЦИИ ПИЩЕВАРИТЕЛЬНЫХ ФЕРМЕНТОВ (STABLE COMPOSITIONS OF DIGESTIVE ENZYMES)

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch in the Russian Federation?

ZENPEP is a drug marketed by

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch in the Russian Federation?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Russian Federation Patent 2,445,952
Patent Title: СТАБИЛЬНЫЕ КОМПОЗИЦИИ ПИЩЕВАРИТЕЛЬНЫХ ФЕРМЕНТОВ (STABLE COMPOSITIONS OF DIGESTIVE ENZYMES)

When can VANFLYTA (quizartinib dihydrochloride) generic drug versions launch in the Russian Federation?

Generic name: quizartinib dihydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2027
Generic Entry Controlled by: Russian Federation Patent 2,441,011
Patent Title: СОЕДИНЕНИЯ ИМИДАЗОЛОТИАЗОЛА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ (IMIDAZOLOTHIAZOL DERIVATIVES FOR TREATING DISEASES)

VANFLYTA is a drug marketed by Daiichi Sankyo Inc. There are eleven patents protecting this drug.

See drug price trends for VANFLYTA.

The generic ingredient in VANFLYTA is quizartinib dihydrochloride. Additional details are available on the quizartinib dihydrochloride profile page.

When can XTANDI (enzalutamide) generic drug versions launch in the Russian Federation?

Generic name: enzalutamide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2027
Generic Entry Controlled by: Russian Federation Patent 2,449,993
Patent Title: ДИАРИЛТИОГИДАНТОИНОВЫЕ СОЕДИНЕНИЯ (DIARYLTHIOHYDATOIC COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are seven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

The generic ingredient in XTANDI is enzalutamide. Additional details are available on the enzalutamide profile page.

When can INLYTA (axitinib) generic drug versions launch in the Russian Federation?

Generic name: axitinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Russian Federation Patent 2,009,136,593

INLYTA is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. Additional details are available on the axitinib profile page.

When can INLYTA (axitinib) generic drug versions launch in the Russian Federation?

Generic name: axitinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Russian Federation Patent 2,518,898

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch in the Russian Federation?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Russian Federation Patent 2,008,144,124
Patent Title: МОДУЛЯТОРЫ АТФ-СВЯЗЫВАЮЩИХ КАССЕТНЫХ ТРАНСПОРТЕРОВ

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch in the Russian Federation?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Russian Federation Patent 2,451,018
Patent Title: МОДУЛЯТОРЫ АТФ-СВЯЗЫВАЮЩИХ КАССЕТНЫХ ТРАНСПОРТЕРОВ (MODULATORS OF ATP-BINDING CASSETTE TRANSPORTERS)

When can BYFAVO (remimazolam besylate) generic drug versions launch in the Russian Federation?

Generic name: remimazolam besylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: Russian Federation Patent 2,009,104,311
Patent Title: БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug. There has been litigation on patents covering BYFAVO

See drug price trends for BYFAVO.

The generic ingredient in BYFAVO is remimazolam besylate. Additional details are available on the remimazolam besylate profile page.

When can BYFAVO (remimazolam besylate) generic drug versions launch in the Russian Federation?

Generic name: remimazolam besylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: Russian Federation Patent 2,470,935
Patent Title: БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ (SHORT-TERM ACTION BENZODIAZEPINE SALTS AND POLYMORPHS THEREOF)

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch in the Russian Federation?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Russian Federation Patent 2,009,104,949
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch in the Russian Federation?

EPIDUO FORTE is a drug marketed by Galderma Labs. 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. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can MULPLETA (lusutrombopag) generic drug versions launch in the Russian Federation?

Generic name: lusutrombopag
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 31, 2027
Generic Entry Controlled by: Russian Federation Patent 2,010,107,169

MULPLETA is a drug marketed by Vancocin Italia. There are three patents protecting this drug.

See drug price trends for MULPLETA.

The generic ingredient in MULPLETA is lusutrombopag. Additional details are available on the lusutrombopag profile page.

When can MULPLETA (lusutrombopag) generic drug versions launch in the Russian Federation?

Generic name: lusutrombopag
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 31, 2027
Generic Entry Controlled by: Russian Federation Patent 2,476,429

When can RELISTOR (methylnaltrexone bromide) generic drug versions launch in the Russian Federation?

Generic name: methylnaltrexone bromide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Russian Federation Patent 2,539,387

RELISTOR is a drug marketed by Salix Pharms and SalixThere are twelve patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering RELISTOR

See drug price trends for RELISTOR.

The generic ingredient in RELISTOR is methylnaltrexone bromide. Additional details are available on the methylnaltrexone bromide profile page.

When can WINLEVI (clascoterone) generic drug versions launch in the Russian Federation?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Russian Federation Patent 2,010,107,599
Patent Title: ФЕРМЕНТАТИВНЫЙ СПОСОБ ПОЛУЧЕНИЯ 17-МОНОЭФИРОВ КОРТЕКСОЛОНА И/ИЛИ ИХ 9,11-ДЕГИДРОПРОИЗВОДНЫХ (CRYSTALLINE FORMS OF CORTEXOLONE-17?-PROPIONATE AND METHOD FOR PREPARING THEM)

WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.

When can WINLEVI (clascoterone) generic drug versions launch in the Russian Federation?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Russian Federation Patent 2,482,190
Patent Title: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ КОРТЕКСОЛОН-17α-ПРОПИОНАТА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (CRYSTALLINE FORMS OF CORTEXOLONE-17?-PROPIONATE AND METHOD FOR PREPARING THEM)

When can WINLEVI (clascoterone) generic drug versions launch in the Russian Federation?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Russian Federation Patent 2,599,452
Patent Title: КРИСТАЛЛИЧЕСКАЯ СОЛЬВАТНАЯ ФОРМА КОРТЕКСОЛОН-17альфа-ПРОПИОНАТА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ (CRYSTALLINE SOLVATE FORM OF CORTEXOLONE-17alpha-PROPIONATE, A PREPARATION METHOD THEREOF AND A PHARMACEUTICAL COMPOSITION BASED THEREON)

When can VIZAMYL (flutemetamol f-18) generic drug versions launch in the Russian Federation?

Generic name: flutemetamol f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 30, 2027
Generic Entry Controlled by: Russian Federation Patent 2,010,101,935
Patent Title: РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)

VIZAMYL is a drug marketed by Ge Healthcare. There is one patent protecting this drug.

See drug price trends for VIZAMYL.

The generic ingredient in VIZAMYL is flutemetamol f-18. Additional details are available on the flutemetamol f-18 profile page.

When can VIZAMYL (flutemetamol f-18) generic drug versions launch in the Russian Federation?

Generic name: flutemetamol f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 30, 2027
Generic Entry Controlled by: Russian Federation Patent 2,475,267
Patent Title: РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)

When can PREPOPIK (citric acid; magnesium oxide; sodium picosulfate) generic drug versions launch in the Russian Federation?

Generic name: citric acid; magnesium oxide; sodium picosulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 12, 2027
Generic Entry Controlled by: Russian Federation Patent 2,010,112,483
Patent Title: СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ (METHOD OF MANUFACTURING PHARMACEUTICAL PRODUCT, CONTAINING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITIONS, CONTAINING THUS OBTAINED GRANULES AND INTERMEDIATE COMPOUND)

PREPOPIK is a drug marketed by Ferring Pharms Inc. There are two patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering PREPOPIK

See drug price trends for PREPOPIK.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

When can PREPOPIK (citric acid; magnesium oxide; sodium picosulfate) generic drug versions launch in the Russian Federation?

Generic name: citric acid; magnesium oxide; sodium picosulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 12, 2027
Generic Entry Controlled by: Russian Federation Patent 2,473,332
Patent Title: СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ (METHOD OF MANUFACTURING PHARMACEUTICAL PRODUCT, CONTAINING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITIONS, CONTAINING THUS OBTAINED GRANULES AND INTERMEDIATE COMPOUND)

When can VELPHORO (sucroferric oxyhydroxide) generic drug versions launch in the Russian Federation?

VELPHORO is a drug marketed by Vifor Fresenius. There are eleven patents protecting this drug. There has been litigation on patents covering VELPHORO

See drug price trends for VELPHORO.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. Additional details are available on the sucroferric oxyhydroxide profile page.

When can VELPHORO (sucroferric oxyhydroxide) generic drug versions launch in the Russian Federation?

Generic name: sucroferric oxyhydroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 16, 2027
Generic Entry Controlled by: Russian Federation Patent 2,648,760
Patent Title: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОКСИГИДРОКСИД ЖЕЛЕЗА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ (PHARMACEUTICAL COMPOSITION COMPRISING IRON OXY-HYDROXIDE, METHOD OF PRODUCTION THEREOF AND USE)

Last updated: May 12, 2026

Russian Federation Branded and Generic Drug Markets Assessment: Regulatory Opportunities, Challenges, and Patent/Competition Risks

The Russian Federation drug market is large, price-controlled, and structurally tilted toward locally manufactured brands and generics. Current policy favors domestic supply, import substitution, and price affordability, while regulatory and market-access hurdles raise barriers for foreign entrants. IP enforcement exists but is uneven in practice, and generic entry risk is shaped less by formal patent strength alone and more by market authorization, tender dynamics, procurement rules, and repeatable manufacturing/CMC compliance.

Core takeaways

Regulatory access is the gating factor: market authorization, clinical data pathways, and manufacturing compliance drive timelines more than IP alone.
Commercial access is procurement-driven: hospital and government tenders, reference pricing, and reimbursement rules determine volume.
Generic launches are feasible but constrained: substitution frameworks, import restrictions, and tender scoring affect uptake.
Foreign-origin product strategies face friction: variability in import availability, changing rules on pricing, and domestic-preferential levers raise execution risk.
Patent and data exclusivity do not fully prevent generic competition when authorization or procurement mechanisms enable earlier entry or volume capture.

What is the size and structure of the Russian branded vs generic drug market?

Quick read: Russia is a high-value, high-volume market with a multi-layered pricing and procurement system. Brands retain share where patents, hospital formularies, and supply reliability align. Generics gain share under price pressure, tender preferences, and successful substitution.

Branded market characteristics

Pricing pressure is managed through regulatory reference pricing and listing mechanisms that constrain ability to price above policy anchors.
Tender inclusion and supply stability often determine effective sales more than national marketing.
Domestic manufacturing is rewarded in practice through procurement economics and supply-chain resilience.

Generic market characteristics

Competitive positioning shifts quickly after a brand loses effective exclusivity or faces supply bottlenecks.
Formulation and dosage equivalence and compliance with Russian quality requirements are decisive.
Uptake is procurement-sensitive: even authorized generics may underperform if tender scoring or substitution rules favor specific listings.

How does Russia regulate drug market authorization and what pathways exist for generics?

Quick read: Market entry relies on Russian authorization and CMC compliance. Generic approval routes exist, but clinical evidence expectations, reference product selection, and data bridging determine burden and timing.

Core authorization concepts shaping branded and generic entry

Russian dossier and registration requirements govern safety, efficacy, quality, and labeling.
Quality (CMC) and manufacturing controls are central, including sterile/non-sterile requirements, process validation, and stability.
Reference product and similarity determine how much bridging data a generic must provide.

What this means for generic competitors

CMC readiness and analytical comparability often decide approval duration.
Device and administration components can trigger additional documentation needs for combination products.
Switching between packaging or dosage strengths can create separate regulatory workstreams if changes are not treated as minor.

What are the key regulatory bodies and compliance risks affecting drug launches?

Quick read: Compliance execution impacts authorization timelines, import clearance, and inspection outcomes. Russian manufacturing and quality expectations can raise the cost and duration of market entry.

Typical compliance risk zones

GMP inspection outcomes: facility qualification, documentation alignment, and data integrity.
Labeling and translation accuracy: Russian-language requirements, indication text consistency, and packaging compliance.
Pharmacovigilance setup: local safety reporting capabilities and processes.
Batch release and import controls: supply-chain and customs processes can become operational bottlenecks.

Opportunity angle

Entrants that build end-to-end compliance for dossier, manufacturing, labeling, and pharmacovigilance can convert longer regulatory timelines into competitive advantage.

When does Russia allow generic substitution and how does that affect branded revenue durability?

Quick read: Generic substitution and tender preferences can materially compress branded revenue after regulatory and commercial inflection points, even if patent barriers exist.

Substitution and procurement mechanics

Substitution rules in practice depend on:
- therapeutic equivalence expectations,
- formulary/tender inclusion,
- procurement contract design,
- and local listing status.
Brands can maintain share where tender preference, hospital continuity, and supply reliability are strong.

Patent vs substitution reality

Patent enforcement can deter competitors but does not fully block authorized generics.
Even authorized generics may struggle to convert share without tender inclusion or substitution acceptance.

What patent and data exclusivity issues drive generic entry risk in Russia?

Quick read: Formal patent rights matter, but execution depends on how generics handle authorization timing, regulatory data, and procurement entry.

Patent estate impact channels

Patentability scope affects whether design-arounds work or litigation risk rises.
Enforcement intensity and litigation tempo influence whether a generic challenger delays launch or proceeds with risk.
Method-of-use and formulation claims can create additional barriers for some product designs.

Data exclusivity impact channels

Data protection can slow direct reliance on clinical data, shifting challenges toward:
- bridging strategies,
- comparative studies,
- or alternative reference approaches allowed by law.

How strong are the patent estates for top brands and what is typical exclusivity loss timing?

Quick read: Russia’s practical exclusivity profile for many products is driven by the gap between:

regulatory authorization timing,
patent term and enforcement behavior,
and local procurement substitution triggers.

Typical pattern for branded revenue durability

Effective durability often ends earlier than headline patent expiry when:
- tenders shift to lower-priced options,
- domestic generics gain inclusion,
- and supply reliability issues emerge.
Some brands maintain share longer through managed tender strategy, not only patent coverage.

What Orange Book–style status exists in Russia, and how do you track it?

Quick read: Russia does not mirror the US Orange Book. Status tracking relies on Russian regulatory listings, tender inclusion, and IP registries/patent databases tied to enforcement and claim scope.

Practical tracking approach for businesses (non-exhaustive)

Regulatory listings: confirmed authorized status, dosage forms, and strengths.
Tender inclusion: which SKUs win procurement.
IP registry and patent litigation: whether enforcement is active and what claims are asserted.

What is the Paragraph IV equivalent risk in Russia for generic challengers?

Quick read: Russia does not use the US Paragraph IV framework. The closest risk analogs are:

regulatory reliance strategies that reduce clinical duplication,
potential IP disputes over manufacturing, labeling, or use claims,
and procurement-based launch timing that can proceed unless blocked by enforcement.

How challengers typically manage risk

Launch sequencing is often designed around:
- avoiding infringement on key claim elements,
- minimizing labeling or indication overreach,
- and aligning manufacturing design with claim scopes.

Which therapies are most active for branded-to-generic transitions in Russia?

Quick read: Transitions occur most frequently in therapies with strong tender economics and mature clinical differentiation that can be mirrored by generics.

High-transition therapy clusters (typical pattern)

Cardiovascular and metabolic drugs
Oncology supportive care and follow-on therapies
Anti-infectives with repeatable manufacturing and established pharmacopoeial/analytical benchmarks
CNS agents with clearer formulation equivalence pathways

What formulation and CMC requirements create the biggest barriers for generic development?

Quick read: The highest barriers are rarely the active ingredient alone. They are:

complex dosage forms,
stability and bioavailability profile replication,
and sterile manufacture for injectables.

Barriers by dosage form

Injectables: sterility assurance, container-closure validation, and batch consistency drive cost.
Modified release: dissolution equivalence and process control complexity.
Narrow therapeutic index drugs: higher scrutiny on bioequivalence and analytical consistency.

Barriers by “what changes” in the generic

Strength variations, salt forms, crystal forms, and excipient profiles can increase CMC work.
Changes to delivery device components can introduce additional regulatory documentation.

How do Russian pricing controls and reimbursement rules affect branded strategy?

Quick read: Pricing is constrained by regulatory mechanisms. Brands that cannot defend cost-position relative to tender and reference pricing lose volume even before exclusivity expiry.

Branded strategy adjustments

Bundle value with procurement contracts or outcomes-based contracts where feasible.
Use localized supply and domestic manufacturing partnerships to protect availability and reduce procurement friction.
Optimize SKU strategy to align with tender frequency and supported dosages.

How does procurement and tender design influence generic market share?

Quick read: Tender design can determine winners. Generics can gain volume when they meet technical requirements and win price-cost weighting.

Tender drivers

price per pack and total treatment cost,
quality/technical compliance score,
local supply reliability,
delivery terms and lead times,
and sometimes domestic-preference scoring elements.

What regulatory opportunities exist for foreign and domestic companies entering Russia?

Quick read: Opportunities cluster around localized manufacturing, portfolio expansion with line extensions, and partnership models that reduce compliance and supply risk.

Opportunity areas

Local manufacturing and contract manufacturing partnerships to reduce logistics risk.
Portfolio buildout through generics that target tender demand rather than just authorized status.
Supplementary forms and line extensions that fill SKU gaps for tender formularies.
CMC modernization for faster dossier generation and recurring product maintenance.

Licensing opportunity angle

Licensing value is highest when:
- it includes dossier know-how,
- manufacturing transfer packages,
- and regulatory support for labeling and pharmacovigilance.

What are the biggest regulatory and operational challenges for foreign companies?

Quick read: Foreign entrants face a compounding stack of risk: authorization timelines, GMP inspections, supply chain disruptions, pricing constraints, and shifting compliance priorities.

Challenge stack

Higher overhead for dossier compliance and language/label alignment.
Manufacturing approvals and periodic GMP readiness.
Import clearance and batch release constraints affecting availability.
Pricing and reimbursement mechanisms limiting revenue upside.

What role do litigation, injunctions, and settlement agreements play in Russia?

Quick read: IP disputes can delay launches, but the practical impact often depends on whether injunction relief is sought and granted and how quickly.

Common litigation vectors (business-relevant)

infringement allegations on composition, formulation, method-of-use, or manufacturing processes,
disputes on labeling and indication correspondence,
and settlements that structure launch timing and supply volumes.

Settlement-driven market structure effects

Settlements can create “staggered” generic entry, preserving brand share longer in targeted tenders.
They can also shift generics to alternative SKUs or indications.

How does Russia handle biosimilars and what changes versus generics?

Quick read: Biosimilars face a different regulatory regime with higher clinical and manufacturing comparability requirements. Competition ramps more slowly than with small-molecule generics.

Biosimilar opportunity and risk

Opportunity: tender-driven demand can accelerate uptake once authorized.
Risk: manufacturing and analytical comparability constraints raise approval and cost.

How does Russia compare with the EU and US on regulatory burden and launch speed?

Quick read: Russia’s launch speed is typically slower than US and EU for many entrants due to dossier complexity, GMP readiness needs, and local compliance. Risk is more operational than purely legal.

Comparative implication for portfolio planning

If a product has expiring exclusivity in major markets, Russia planning must account for:
- local authorization lead times,
- manufacturing transfer schedules,
- and tender cycle timing.

What are generic entry scenarios for a brand losing exclusivity in Russia?

Quick read: Generic entry generally follows a multi-path playbook tied to authorization readiness, IP posture, and tender inclusion.

Scenario map

Low IP friction / fast dossier readiness: authorized generic launches quickly and captures tender share.
IP friction / active disputes: launch proceeds at risk or is delayed by enforcement posture and injunctive relief.
High CMC barrier dosage form: generic launch lags due to bioequivalence and release testing complexity.
Tender inclusion lag: authorization occurs but volume remains limited until tender inclusion cycles.

Key risk-adjusted considerations for investing, licensing, or litigating in Russia

Quick read: Russia rewards operational execution and local manufacturing alignment. IP strategy must integrate with procurement and regulatory sequencing.

For investors

Evaluate:
- time-to-authorization,
- time-to-tender inclusion,
- manufacturing transfer and GMP inspection readiness,
- and price corridor feasibility.

For licensors

Deal structures should require:
- manufacturing and quality transfer support,
- dossier and regulatory maintenance obligations,
- and pharmacovigilance operational capability.

For litigators

Case value is highest when it targets:
- enforceable claims tied to key SKU/manufacturing pathways,
- rapid injunctive relief,
- and settlement terms that shape tender behavior.

Key Takeaways

Russia is a procurement- and compliance-driven market where authorization and tender inclusion dictate effective sales more than brand advertising alone.
Generics can erode branded volume rapidly after practical exclusivity triggers, with uptake shaped by substitution and tender design.
Foreign entry faces a stack of operational challenges: GMP readiness, dossier execution, pharmacovigilance setup, and pricing constraints.
IP rights can restrain competitors but do not guarantee volume protection without alignment to enforcement timing and procurement mechanisms.
Sustainable competition requires repeatable CMC performance and a localized supply strategy.

FAQs

How do Russian GMP inspections affect timelines for generic and biosimilar launches?
What documentation is typically required to register a generic in Russia when the reference product is imported?
How do tenders in Russia score technical compliance versus price, and how does that change generic entry strategy?
What claim types in Russia most often block generic launches: composition, formulation, or method-of-use?
How should companies plan Russian portfolio SKU selection to maximize tender inclusion and substitution uptake?

References (APA)

Federal Law of the Russian Federation No. 61-FZ “On the Circulation of Medicines.”
FDA-like and Eur-Lex style guidance on GMP expectations and pharmacovigilance frameworks for medical products (jurisdictional standards as implemented in Russia).
Government procurement framework and tender regulations in the Russian Federation as implemented for medicines (federal and municipal procurement rules).

Russian Federation Branded and Generic Drug Markets Assessment: Regulatory Opportunities, Challenges, and Patent/Competition Risks

What is the size and structure of the Russian branded vs generic drug market?

Branded market characteristics

Generic market characteristics

How does Russia regulate drug market authorization and what pathways exist for generics?

Core authorization concepts shaping branded and generic entry

What this means for generic competitors

What are the key regulatory bodies and compliance risks affecting drug launches?

Typical compliance risk zones

Opportunity angle

When does Russia allow generic substitution and how does that affect branded revenue durability?

Substitution and procurement mechanics

Patent vs substitution reality

What patent and data exclusivity issues drive generic entry risk in Russia?

Patent estate impact channels

Data exclusivity impact channels

How strong are the patent estates for top brands and what is typical exclusivity loss timing?

Typical pattern for branded revenue durability

What Orange Book–style status exists in Russia, and how do you track it?

Practical tracking approach for businesses (non-exhaustive)

What is the Paragraph IV equivalent risk in Russia for generic challengers?

How challengers typically manage risk

Which therapies are most active for branded-to-generic transitions in Russia?

High-transition therapy clusters (typical pattern)

What formulation and CMC requirements create the biggest barriers for generic development?

Barriers by dosage form

Barriers by “what changes” in the generic

How do Russian pricing controls and reimbursement rules affect branded strategy?

Branded strategy adjustments

How does procurement and tender design influence generic market share?

Tender drivers

What regulatory opportunities exist for foreign and domestic companies entering Russia?

Opportunity areas

Licensing opportunity angle

What are the biggest regulatory and operational challenges for foreign companies?

Challenge stack

What role do litigation, injunctions, and settlement agreements play in Russia?

Common litigation vectors (business-relevant)

Settlement-driven market structure effects

How does Russia handle biosimilars and what changes versus generics?

Biosimilar opportunity and risk

How does Russia compare with the EU and US on regulatory burden and launch speed?

Comparative implication for portfolio planning

What are generic entry scenarios for a brand losing exclusivity in Russia?

Scenario map

Key risk-adjusted considerations for investing, licensing, or litigating in Russia

For investors

For licensors

For litigators

Key Takeaways

FAQs

References (APA)

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