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Last Updated: June 12, 2025

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

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Russian Federation: These 22 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Russian Federation: These 22 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 APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,007,147,343
Patent Title: ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,010,107,843
Patent Title: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,010,116,863
Patent Title: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,408,368
Patent Title: ПРЕПАРАТЫ СОЛИ БУПРОПИОНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ (MODIFIED RELEASE BUPROPION SALT PREPARATIONS)

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,485,942
Patent Title: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF)

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Russian Federation Patent 2,485,943
Patent Title: БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ (BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS THEREOF)

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
Generic Entry Controlled by: Russian Federation Patent 2,007,148,072
Patent Title: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-[(2,4-ДИХЛОР-5-МЕТОКСИФИНИЛ)АМИНО]-6- МЕОКСИ-7-[3-(4-МЕТИЛ-1-ПИПЕРАЗИНИЛ)ПРОПОКСИ]-3-ХИНАЛИНКАРБОНИТРИЛ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Russian Federation Patent 2,008,107,718
Patent Title: АСИММЕТРИЧЕСКОЕ КАТАЛИТИЧЕСКОЕ ВОССТАНОВЛЕНИЕ ОКСКАРБАЗЕПИНА

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Russian Federation Patent 2,439,060
Patent Title: АСИММЕТРИЧЕСКОЕ КАТАЛИТИЧЕСКОЕ ВОССТАНОВЛЕНИЕ ОКСКАРБАЗЕПИНА (ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE)

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate 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, 2025
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 one hundred patent family members in twenty-six countries. There has been litigation on patents covering CREON

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. Seven suppliers are 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, 2025
Generic Entry Controlled by: Russian Federation Patent 2,008,109,652
Patent Title: ФАРМАЦЕВТИЧЕКИЕ КОМПОЗИЦИИ РЕГУЛИРУЕМОГО ВЫСВОБОЖДЕНИЯ НЕСТАБИЛЬНЫХ В КИСЛОЙ СРЕДЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ

CREON is a drug marketed by

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

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. Seven suppliers are 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, 2025
Generic Entry Controlled by: Russian Federation Patent 2,408,364
Patent Title: ЯДРА МИКРОПЕЛЛЕТ ПАНКРЕАТИНА, ПРИГОДНЫЕ ДЛЯ НАНЕСЕНИЯ ЭНТЕРОСОЛЮБИЛЬНОГО ПОКРЫТИЯ (PANCREATINE MICROPELLET NUCLEI TO BE ENTERO-SOLUBLE COATED)

CREON is a drug marketed by

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

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. Seven suppliers are 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, 2025
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)

CREON is a drug marketed by

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

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. Seven suppliers are listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) 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 09, 2025
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 twenty-eight patent family members in forty countries. There has been litigation on patents covering ENTRESTO SPRINKLE

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Seven 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 09, 2025
Generic Entry Controlled by: Russian Federation Patent 2,012,107,219
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP

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

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Seven 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 09, 2025
Generic Entry Controlled by: Russian Federation Patent 2,459,809
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSINE RECEPTOR ANTAGONIST AND NEP INHIBITOR)

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

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Seven 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 09, 2025
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)

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

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

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

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
Generic Entry Controlled by: Russian Federation Patent 2,008,126,277
Patent Title: СОЕДИНЕНИЕ-ПРЕДШЕСТВЕННИК ОРГАНИЧЕСКОГО СОЕДИНЕНИЯ, МЕЧЕННОГО РАДИОАКТИВНЫМ ГАЛОГЕНОМ

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.

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 29, 2025
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.

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 XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2025
Generic Entry Controlled by: Russian Federation Patent 2,008,120,338
Patent Title: ПОЛИМОРФЫ С-MET/HGFR ИНГИБИТОРА

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: December 05, 2025
Generic Entry Controlled by: Russian Federation Patent 2,387,650
Patent Title: ПОЛИМОРФЫ С-MET/HGFR ИНГИБИТОРА (C-MET/HGFR INHIBITOR POLYMORPHS)

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 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 six patents protecting this drug.

This drug has one hundred and ninety-eight patent family members in forty-four countries.

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)

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

This drug has one hundred and ninety-eight patent family members in forty-four countries.

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 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)

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 AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,134,489
Patent Title: СОСТАВ В МЯГКОЙ ЖЕЛАТИНОВОЙ КАПСУЛЕ

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries. There has been litigation on patents covering AMITIZA

See drug price trends for AMITIZA.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this API. Twenty suppliers are listed for this generic product. Additional details are available on the lubiprostone profile page.

When can AMITIZA (lubiprostone) generic drug versions launch?

Generic name: lubiprostone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 24, 2026
Generic Entry Controlled by: Russian Federation Patent 2,420,291
Patent Title: СОСТАВ В МЯГКОЙ ЖЕЛАТИНОВОЙ КАПСУЛЕ (COMPOSITION IN SOFT GELATIN CAPSULE)

Drug Price Trends for AMITIZA
AMITIZA is a drug marketed by Sucampo Pharma Llc. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in nineteen countries. There has been litigation on patents covering AMITIZA

See drug price trends for AMITIZA.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this API. Twenty suppliers are listed for this generic product. Additional details are available on the lubiprostone profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,131,956
Patent Title: СПОСОБ ПОЛУЧЕНИЯ АГОНИСТА А2А-АДЕНОЗИНОВОГО РЕЦЕПТОРА И ЕГО ПОЛИМОРФОВ

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Sixteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: Russian Federation Patent 2,447,081
Patent Title: СПОСОБ ПОЛУЧЕНИЯ АГОНИСТА A2A-АДЕНОЗИНОВОГО РЕЦЕПТОРА И ЕГО ПОЛИМОРФОВ (METHOD OF PRODUCING A2A-ADENOSINE RECEPTOR AGONIST AND POLYMORPHS THEREOF)

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Sixteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,140,944
Patent Title: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

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

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the amphetamine profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
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)

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

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

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the amphetamine profile page.

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

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: Russian Federation Patent 2,008,140,944
Patent Title: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА

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 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 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 2,009,101,082
Patent Title: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ

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

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

See drug price trends for EMBEDA.

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

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

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: 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
Patent Title: ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА

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

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

See drug price trends for TEKTURNA HCT.

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

When can 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 2,491,058
Patent Title: ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА (GALENA COMPOSITION OF ALISKIREN AND HYDROCHLOROTHIAZIDE)

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

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

See drug price trends for TEKTURNA HCT.

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,102,220
Patent Title: ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can VAFSEO (vadadustat) generic drug versions launch?

Generic name: vadadustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 26, 2026
Generic Entry Controlled by: Russian Federation Patent 2,429,226
Patent Title: ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (PROLYL HYDROXYLASE INHIBITORS AND APPLICATION METHODS THEREOF)

VAFSEO is a drug marketed by Akebia. There are thirteen patents protecting this drug.

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

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

When can EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,102,273
Patent Title: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

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

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can EXFORGE HCT (amlodipine besylate; hydrochlorothiazide; valsartan) generic drug versions launch?

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Russian Federation Patent 2,449,786
Patent Title: ТВЕРДЫЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ВАЛСАРТАНА, АМЛОДИПИНА И ГИДРОХЛОРТИАЗИДА И СПОСОБ ИХ ПОЛУЧЕНИЯ (SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD FOR MAKING THEM)

Drug Price Trends for EXFORGE HCT
EXFORGE HCT is a drug marketed by Novartis.

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

See drug price trends for EXFORGE HCT.

The generic ingredient in EXFORGE HCT is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this API. Five suppliers are listed for this generic product. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

When can BYFAVO (remimazolam besylate) generic drug versions launch?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2026
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.

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

See drug price trends for BYFAVO.

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

When can BYFAVO (remimazolam besylate) generic drug versions launch?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2026
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)

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.

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

See drug price trends for BYFAVO.

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

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

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

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

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

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,136,952
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

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

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,144,414
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-eight patent family members in twenty-five countries. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

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

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

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

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

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

See drug price trends for EPIDUO FORTE.

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

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,136,952
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

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

See drug price trends for EPIDUO FORTE.

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

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Russian Federation Patent 2,012,144,414
Patent Title: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

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

See drug price trends for EPIDUO FORTE.

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

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Russian Federation Patent 2,009,106,053
Patent Title: КОНЦЕНТРИРОВАННЫЕ РАСТВОРЫ МЕТОТРЕКСАТА

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

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

See drug price trends for RASUVO.

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

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Russian Federation Patent 2,403,044
Patent Title: КОНЦЕНТРИРОВАННЫЕ РАСТВОРЫ МЕТОТРЕКСАТА (CONCENTRATED METHOTREXATE SOLUTIONS)

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

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

See drug price trends for RASUVO.

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

When can 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)

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.

Market Analysis and Financial Projection

The Russian pharmaceutical market is undergoing significant transformation, shaped by geopolitical pressures, domestic production initiatives, and evolving regulatory frameworks. Valued at RUB 2.9 trillion ($24.1 billion) in 2023, the market is projected to grow to RUB 3.7–4.5 trillion ($39.6–48.2 billion) by 2030, driven by generics dominance and strategic localization efforts[1][3][7]. Below is a detailed assessment of the branded and generic drug markets, along with regulatory opportunities and challenges.


Market Structure and Dynamics

Generics Domination

  • Volume vs. Value: Generics account for 85% of sales by volume but only 45% by value, reflecting low pricing power despite widespread use[12][14]. In contrast, imported branded drugs hold 66% of the market value, particularly in oncology and rare diseases[1][11].
  • Growth Drivers: The generics market grew at an 11.6% CAGR (2017–2022), reaching $11.9 billion, with further growth expected to $18.3 billion by 2027[9]. Retail pharmacies dominate volumes, while public procurement prioritizes subsidized essential medicines[7][13].

Branded Drug Challenges

  • Sanctions Impact: Over 25% of the market (previously controlled by Western firms) faces disruption, with 300 innovative therapies at risk of delayed entry[1][7].
  • Price Pressures: State-mandated price caps and preference for cheaper alternatives in public tenders limit branded drug profitability[11][13].

Regulatory Landscape

Key Policies

  1. Localization Requirements:
    • By 2025: 90% domestic production of vital medicines, including APIs[10][11].
    • By 2030: 80% full-cycle production (APIs + finished drugs) for critical therapies like oncology[3][12].
  2. Import Substitution:
    • Mandatory preference for Russian-made drugs in public procurement, targeting 72.8% domestic share in hospital purchases by 2025[1][4].
    • Extended allowances for foreign-packaged drugs with Russian labels until 2025 to prevent shortages[5].
  3. Registration Hurdles:
    • Complex Dossier Requirements: Mandatory preclinical/clinical data, GMP compliance, and Russian-language documentation[6][10].
    • Patent Risks: Generics mimicking foreign brand names face legal challenges, emphasizing the need for robust trademark protection[15].

Opportunities

For Generics

  • Public Procurement: Over RUB 1.8 trillion allocated for state healthcare programs, favoring cost-effective generics[3][11].
  • Biotech Investments: Government programs like Pharma 2030 aim to triple R&D spending, focusing on biosimilars and advanced therapies[7][12].
  • Export Potential: Regulatory harmonization with BRICS/ASEAN countries to facilitate generics exports[6][12].

For Branded Drugs

  • Niche Therapeutic Areas: Demand for oncology, HIV, and rare disease treatments remains high, with 40% of high-cost drugs still imported[1][11].
  • Digital Health Integration: E-prescriptions and AI-driven pharmacovigilance systems reduce costs for innovative therapies[7][12].

Challenges

Systemic Barriers

  1. API Dependency: 80% of APIs are imported, complicating localization goals for critical drugs[1][10].
  2. Quality Concerns: Only 3% of domestically developed drugs pass preclinical trials, undermining trust[1][6].
  3. Sanctions Fallout:
    • Brain Drain: Loss of 1,300+ clinical trials and skilled professionals[7][12].
    • Technology Gaps: Restricted access to Western equipment delays advanced drug development[11][12].

Strategic Recommendations

For Generics Manufacturers

  • API Localization: Partner with chemical parks for oncology/antibiotic API production[12].
  • Regional Procurement: Leverage third-party distributors to navigate 80+ regional tenders with varying requirements[4].

For Branded Drug Companies

  • Public-Private Partnerships: Engage in R&D accelerators like Skolkovo-AstraZeneca to access state funding[7][14].
  • Regulatory Compliance: Align with ICH standards to streamline exports to friendly markets[12].

Future Outlook

Under a base-case scenario, the market could reach RUB 4.5 trillion by 2030 (5.7% CAGR), driven by localized APIs and digital health adoption. A downside scenario (3.9% CAGR) risks stagnation if sanctions persist and quality gaps remain unaddressed[7][12].

"Innovation is the new thing that increases the efficiency of processes and provides what the market wants: treating patients with severe, previously incurable diseases." — Vadim Merkulov, Russian Ministry of Health[3].


Key Takeaways:

  • Generics dominate volume, but branded drugs retain value in niche therapeutic areas.
  • Regulatory shifts prioritize localization but face API dependency and quality hurdles.
  • Strategic partnerships and digital integration are critical for long-term growth.

FAQs:

  1. What drives generics growth in Russia?
    Cost containment in public procurement and state-mandated import substitution[11][14].
  2. How do sanctions impact branded drugs?
    They disrupt clinical trials and delay access to 300+ innovative therapies[1][7].
  3. What’s the timeline for API localization?
    90% domestic API production targeted by 2025, but current reliance remains at 80% imports[10][12].
  4. Are foreign drugs still entering Russia?
    Yes—foreign drug SKUs increased by 519 in 2024 due to extended labeling allowances[5][8].
  5. How to mitigate registration risks?
    Secure Cyrillic/Latin trademark registrations and align with updated GMP standards[6][15].

References

  1. https://www.drugpatentwatch.com/blog/inside-the-russian-pharma-industry-key-players-and-innovations/
  2. https://www.drugdiscoverytrends.com/why-russias-pharmaceutical-market-value-will-double-in-four-years/
  3. https://www.thepharmaletter.com/generics/russian-pharmaceutical-market-to-reach-3-7-trillion-roubles-by-2030
  4. https://blog.volkovlaw.com/2014/06/challenges-for-pharmaceutical-companies-in-russia/
  5. https://gxpnews.net/en/2025/01/special-regulations-for-foreign-packaged-medicines-extended-until-the-end-of-2025/
  6. https://www.wisdomlib.org/science/journal/world-journal-of-pharmaceutical-research/d/doc1375413.html
  7. https://yakovpartners.com/publications/russian-pharma-2030/
  8. https://gxpnews.net/en/2025/01/rnc-pharma-for-the-first-time-in-5-years-the-range-of-foreign-drugs-in-russia-has-resumed-growth/
  9. https://www.researchandmarkets.com/reports/5651018/russia-generics-market-summary-competitive
  10. https://www.gorodissky.com/publications/articles/procedures-and-strategies-for-pharmaceutical-brands-russia/
  11. https://revista.unicuritiba.edu.br/index.php/RIMA/article/download/5753/371373869
  12. https://forumspb.com/en/archive/2021/programme/93326/?year=2021&ELEMENT_ID=93326
  13. https://www.giz.de/de/downloads/Jordanian%20Pharmaceutical%20Sector%20Export%20Guide%20to%20Russia%20(1).pdf
  14. https://www.statista.com/statistics/1121762/generic-and-original-pharmaceuticals-sales-share-russia/
  15. https://gowlingwlg.com/fr/insights-resources/articles/2020/amendments-affecting-pharmaceuticals-in-russia
Last updated: 2025-03-19

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