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Last Updated: December 18, 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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China: These 29 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "China: These 29 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: China Patent 102,329,270
Patent Title: Hydrogen sulfate salt

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

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

See drug price trends for KOSELUGO.

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

When can VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 05, 2026
Generic Entry Controlled by: China Patent 101,868,239
Patent Title: Salts of potassium ATP channel openers and uses thereof

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

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

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

When can VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 05, 2026
Generic Entry Controlled by: China Patent 103,172,592
Patent Title: Salts of potassium atp channel openers and uses thereof

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

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

The generic ingredient in VYKAT XR is diazoxide choline. There are five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the diazoxide choline 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: China Patent 101,400,363
Patent Title: Pharmaceutical compositions with enhanced stability

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 RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: China Patent 101,420,948
Patent Title: Intramuscular antiviral treatments

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

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: China Patent 104,784,166
Patent Title: Antiviral compound, dosage form including same, and uses thereof

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

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: China Patent 101,460,176
Patent Title: Ocular allergy treatments

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: China Patent 102,895,234
Patent Title: Ocular allergy treatments

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

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

When can VOCABRIA (cabotegravir sodium) generic drug versions launch?

Generic name: cabotegravir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 28, 2026
Generic Entry Controlled by: China Patent 101,212,903
Patent Title: Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity

VOCABRIA is a drug marketed by Viiv Hlthcare. There are two patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-three countries.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: China Patent 101,437,493

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

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

See drug price trends for TRADJENTA.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: China Patent 102,526,737

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

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

See drug price trends for TRADJENTA.

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

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: China Patent 103,948,597
Patent Title: 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine used for treatment of pain or depression residual symptoms related with sleep and cognition

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for TRINTELLIX.

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

When can 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: China Patent 101,677,963

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 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: China Patent 103,169,711

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

This drug has seventy-four patent family members in twenty-three 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 BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: China Patent 103,145,773

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: China Patent 103,145,773

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

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

See drug price trends for FARXIGA.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: China Patent 103,145,773

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

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

See drug price trends for QTERN.

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

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: China Patent 102,627,639
Patent Title: Macrocydic inhibitors of hepatitis c virus.

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

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

See drug price trends for OLYSIO.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: China Patent 101,242,811
Patent Title: Controlled release pharmaceutical compositions for acid labile drugs

CREON is a drug marketed by

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

See drug price trends for CREON.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: China Patent 101,242,812
Patent Title: Pancreatin micropellets suitable for enteric coating

CREON is a drug marketed by

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

See drug price trends for CREON.

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

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: China Patent 101,511,365

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSUMIT

See drug price trends for OPSUMIT.

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

When can OPSYNVI (macitentan; tadalafil) generic drug versions launch?

Generic name: macitentan; tadalafil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: China Patent 101,511,365

OPSYNVI is a drug marketed by Actelion. There are three patents protecting this drug.

This drug has ninety-nine patent family members in thirty-four countries. There has been litigation on patents covering OPSYNVI

See drug price trends for OPSYNVI.

The generic ingredient in OPSYNVI is macitentan; tadalafil. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan; tadalafil profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: China Patent 101,273,017

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: China Patent 101,273,017

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: China Patent 101,267,810

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

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

See drug price trends for ESBRIET.

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

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: China Patent 103,393,607

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

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

See drug price trends for ESBRIET.

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

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: China Patent 103,735,530

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

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

See drug price trends for ESBRIET.

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

When can ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: China Patent 101,287,719
Patent Title: Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment

ZUNVEYL is a drug marketed by Alpha Cognition. There are three patents protecting this drug.

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

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

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: China Patent 103,254,119

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

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

See drug price trends for INPEFA.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: China Patent 102,702,119
Patent Title: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

See drug price trends for ENTRESTO SPRINKLE.

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

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

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: China Patent 101,535,336

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

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

See drug price trends for KORSUVA.

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

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: China Patent 101,326,175

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 ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: China Patent 106,667,918

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

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

See drug price trends for ZTALMY.

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

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: China Patent 105,012,303

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

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

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the bedaquiline fumarate profile page.

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: China Patent 105,193,799

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

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

See drug price trends for BEVYXXA.

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

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

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: China Patent 101,360,718
Patent Title: Novel hydrogen sulfate salt

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

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

See drug price trends for KOSELUGO.

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

China Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges

Last updated: July 28, 2025

Overview of the Chinese Pharmaceutical Market

China's pharmaceutical sector ranks as the second-largest globally, driven by a population exceeding 1.4 billion and expanding healthcare infrastructure. The industry’s rapid growth reflects increasing healthcare demands, robust government policies, and a dynamic regulatory environment. China’s drug market encompasses both branded and generic medications, with generics accounting for approximately 90% of the total prescription volume due to cost considerations and regulatory shifts aiming to enhance affordability while ensuring quality.

Market Dynamics: Branded vs. Generic Drugs in China

Branded Drugs

Branded drugs—innovative, patent-protected medicines—constitute a smaller market share, primarily in high-value, innovative therapies such as biologics and specialty drugs. Multinational pharmaceutical companies dominate this segment, benefiting from strong R&D infrastructure and global patent portfolios. However, the penetration rate remains limited compared to developed markets due to price sensitivity, local manufacturing capabilities, and regulatory reforms favoring generics.

Generic Drugs

Generics dominate China’s pharmaceutical landscape, driven by government policies aimed at reducing drug costs and expanding access. The legislative push toward quality consistency has elevated the standard for generics, promoting domestic production and facilitating international companies to localize their products.

Regulatory Environment: Opportunities and Challenges

Regulatory Opportunities

  1. Registration Reforms and Market Access
    China's National Medical Products Administration (NMPA) has undertaken significant reforms to streamline drug registration processes. The implementation of the Urgent Review and Approval pathways for innovative medicines and accelerated registration for domestically developed drugs enhances opportunities for both domestic and international firms to enter the market swiftly.

  2. Emphasis on Quality Standards
    Aligning with international standards, China has adopted the Pharmacopoeia Commission's quality guidelines, fostering confidence in the safety and efficacy of generics. Such measures provide opportunities for high-quality local manufacturing and attract foreign investment through joint ventures or licensing agreements.

  3. Encouragement of Innovation
    The Chinese government promotes innovation via policies such as the "Made in China 2025" and the "Drug Innovation Center" initiative. These policies incentivize R&D investments in Biologics, personalized medicine, and rare disease treatments, creating opportunities for branded pharmaceutical development.

  4. Intellectual Property (IP) Protection
    Enhanced IP enforcement and patent protection laws, including the 2020 amendments to the Patent Law, improve the landscape for branded drug innovators, encouraging continued innovation and foreign direct investment.

Regulatory Challenges

  1. Patent and Data Exclusivity
    Despite improvements, challenges remain regarding the duration and enforcement of data and patent exclusivity. The historic prevalence of local manufacturers producing generics shortly after patent expiry limits the window for branded drug profitability, deterring innovation investments.

  2. Complex Regulatory Pathways
    While reforms have eased some procedures, navigating China’s regulatory landscape still involves complex, often opaque processes with regional disparities, leading to delays and increased compliance costs for foreign firms.

  3. Quality Control and Standardization
    Although standards have improved, the heterogeneity of manufacturing practices and regulatory enforcement across regions poses risks to product quality and market access for foreign companies.

  4. Price Pressure and Reimbursement Policies
    The government’s focus on cost containment via price negotiations and rebate policies exerts downward pressure on drug prices, affecting profitability, particularly in the generics segment. The National Reimbursement Drug List (NRDL) expansion promotes access but constrains margins.

Market Opportunities

For Branded Drugs

  • Biologics and Biosimilars: Growing demand for biologic therapies—especially in oncology and autoimmune diseases—presents significant growth opportunities due to the government’s supportive policies and expanding healthcare coverage.

  • Innovative Therapies: Emerging focus on gene therapy, personalized medicine, and next-generation therapeutics aligns with China’s ambition to be a global innovation hub.

  • International Collaborations: Licensing, joint ventures, and local manufacturing partnerships can accelerate market entry and compliance, leveraging China’s expanding R&D ecosystem.

For Generic Drugs

  • High-Quality Generics: Increasing regulatory quality standards open avenues for domestic firms to develop high-quality generics that meet or exceed international standards, enabling global export.

  • Over-the-Counter (OTC) Expansion: The liberalization of OTC drugs offers growth in consumer-facing segments, especially in traditional Chinese medicine and health supplement markets.

  • Specialty Generics: Focus on complex generics and specialty formulations can command higher prices and margins amid intense competition in standard generics.

Regulatory Opportunities: Policy Drivers

  • China’s 14th Five-Year Plan (2021-2025) emphasizes R&D innovation, healthcare reform, and international cooperation, providing a fertile environment for strategic positioning.

  • The "Consistency Evaluation" of Generics aims at standardizing generic quality, presenting opportunities for manufacturers to demonstrate equivalence and upgrade formulations to access premium pricing.

  • Reimbursements and Price Negotiations: Expanding inclusion of new drugs into the NRDL incentivizes manufacturers to meet cost and quality benchmarks, thus fostering innovation and competition.

Challenges in Navigating the Regulatory Landscape

  • Evolving Policies: Rapid policy changes necessitate agile regulatory compliance strategies, often challenging for firms unfamiliar with local procedures.

  • Regional Disparities: Variations in enforcement and registration timelines across regions complicate market entry strategies.

  • Intellectual Property Risks: Although improved, IP protection enforcement remains inconsistent, requiring vigilant legal strategies to mitigate infringement risks.

  • Post-Market Surveillance: Intensified monitoring and adverse event reporting demand robust pharmacovigilance systems, increasing operational complexities and costs.

Conclusion

The Chinese branded and generic drug markets offer substantial opportunities amid a shifting regulatory landscape that favors high-quality, innovative, and locally adapted pharmaceuticals. Regulatory reforms aimed at harmonizing standards, enhancing IP protections, and accelerating registration processes are opening avenues for both domestic and international pharmaceutical companies. However, the sector presents challenges related to regulatory complexity, pricing pressures, quality assurance, and enforcement consistency that require strategic navigation.

Companies seeking to capitalize on China's pharmaceutical market must adopt flexible, compliant, and innovation-driven approaches. Emphasizing local collaborations, investing in quality manufacturing, and staying abreast of policy developments are crucial for sustained success in this dynamic landscape.


Key Takeaways

  • Market Shift: China’s move towards high-quality generics and innovative biologics creates opportunities for companies aligned with quality standards and R&D investments.

  • Regulatory Reforms: Policy changes, including expedited registration pathways and stricter quality standards, facilitate faster market access but require careful compliance management.

  • Innovation Focus: Government support for biopharmaceutical innovation and IP protection incentivizes international firms to engage in R&D collaborations.

  • Pricing and Reimbursement: Cost containment policies and NRDL expansion challenge profitability but also open doors for value-based pricing models.

  • Strategic Necessity: Success in China's pharmaceutical market hinges on local partnerships, regulatory agility, quality assurance, and adapting to policy evolutions.


FAQs

  1. How has China's regulatory landscape evolved for pharmaceutical approvals?
    China has implemented reforms such as streamlined registration procedures, the introduction of fast-track pathways for innovative drugs, and increased focus on manufacturing quality standards, aligning closer to international norms and reducing approval times.

  2. What role do generics play in China’s drug market?
    Generics constitute the majority of prescriptions due to their affordability and regulatory emphasis on quality, making them a crucial segment for domestic and international companies looking to expand in China.

  3. What are the opportunities for biotech and biologics companies in China?
    China’s supportive policies, increasing healthcare demand, and government incentives for biologic innovation present significant growth opportunities, particularly in oncology, autoimmune, and rare diseases.

  4. What challenges do foreign firms face in China’s pharmaceutical regulation?
    Foreign companies encounter complex regulatory procedures, inconsistent enforcement, IP protection concerns, and price pressures from government negotiation policies, necessitating strategic local engagement and compliance.

  5. How can companies leverage China’s policies to succeed in the market?
    By aligning with national priorities such as innovation, quality standards, and affordability, forming local partnerships, and maintaining regulatory agility, firms can capitalize on China’s evolving pharmaceutical landscape.


References

  1. National Medical Products Administration (NMPA). China’s pharmaceutical administrative reforms and registration policies.
  2. China Food and Drug Administration (CFDA). Guidelines on Quality Standards for Generics.
  3. Made in China 2025. Strategic plan for innovation-led growth in the manufacturing sector.
  4. China’s 14th Five-Year Plan (2021-2025). Healthcare and biotech industry directives.
  5. World Health Organization. Insights into China's pharmaceutical regulatory system and market trends.

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