Last Updated: June 27, 2026

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

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Taiwan: These 42 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Taiwan: These 42 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can BYDUREON (exenatide synthetic) generic drug versions launch in Taiwan?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 200,811,127
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 201,509,927
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I421245

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I466876

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I519528

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 200,811,127
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 201,509,927
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I466876

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I519528

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four 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 in Taiwan?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 200,811,127
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent 201,509,927
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I466876

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Taiwan Patent I519528

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

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

See drug price trends for QTERN.

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

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Taiwan Patent 200,909,422
Patent Title: Modulators of pharmacokinetic properties of therapeutics

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Taiwan Patent I411613

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Taiwan Patent I448457

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Taiwan Patent I496778

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Taiwan Patent I533868

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

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

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Taiwan Patent 200,817,013
Patent Title: Adhesive preparation

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. Two suppliers are 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 in Taiwan?

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: Taiwan Patent I414299

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. Two suppliers are listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Taiwan?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Taiwan Patent 200,813,029
Patent Title: Hepatitis C virus inhibitors

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Taiwan?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Taiwan Patent 200,934,486
Patent Title: Hepatitis C virus inhibitors

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Taiwan?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Taiwan Patent I400072

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Taiwan?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Taiwan Patent I432426

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

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

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can BRILINTA (ticagrelor) generic drug versions launch in Taiwan?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Taiwan Patent 200,817,412
Patent Title: Pharmaceutical compositions 457

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

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

When can OPSUMIT (macitentan) generic drug versions launch in Taiwan?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Taiwan Patent 200,823,198
Patent Title: Therapeutic compositions

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 one hundred and one patent family members in thirty-five 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. Twelve suppliers are listed for this generic product. Additional details are available on the macitentan profile page.

When can OPSUMIT (macitentan) generic drug versions launch in Taiwan?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Taiwan Patent I388556

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 one hundred and one patent family members in thirty-five 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. Twelve suppliers are listed for this generic product. Additional details are available on the macitentan profile page.

When can LIVDELZI (seladelpar lysine) generic drug versions launch in Taiwan?

Generic name: seladelpar lysine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 13, 2026
Generic Entry Controlled by: Taiwan Patent 200,804,256
Patent Title: Novel lysine salts of 4-((phenoxyalkyl)thio)-phenoxyacetic acid derivatives

LIVDELZI is a drug marketed by Gilead Sciences Inc. There are six patents protecting this drug.

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

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

When can LIVDELZI (seladelpar lysine) generic drug versions launch in Taiwan?

Generic name: seladelpar lysine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 13, 2026
Generic Entry Controlled by: Taiwan Patent I414510

LIVDELZI is a drug marketed by Gilead Sciences Inc. There are six patents protecting this drug.

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

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

When can INREBIC (fedratinib hydrochloride) generic drug versions launch in Taiwan?

Generic name: fedratinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 01, 2026
Generic Entry Controlled by: Taiwan Patent 200,804,308
Patent Title: Biaryl meta-pyrimidine inhibitors of kinases

INREBIC is a drug marketed by Bristol-myers. There are five patents protecting this drug.

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

See drug price trends for INREBIC.

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

When can LYRICA CR (pregabalin) generic drug versions launch in Taiwan?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 01, 2026
Generic Entry Controlled by: Taiwan Patent 200,803,831
Patent Title: Solid pharmaceutical compositions containing pregabalin

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-five suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can BEVYXXA (betrixaban) generic drug versions launch in Taiwan?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Taiwan Patent 200,736,221
Patent Title: Novel pharmaceutical salts and polymorphs of a Factor Xa inhibitor

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 BEVYXXA (betrixaban) generic drug versions launch in Taiwan?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Taiwan Patent I443088

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 ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch in Taiwan?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Taiwan Patent 201,402,111
Patent Title: Dual-acting compound, pharmaceutical composition containing it, process for its preparation and use thereof

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

This drug has one hundred and eight patent family members in thirty-nine 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-six suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can PYLARIFY (piflufolastat f-18) generic drug versions launch in Taiwan?

Generic name: piflufolastat f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Taiwan Patent 200,836,765
Patent Title: Heterodimers of glutamic acid

PYLARIFY is a drug marketed by Progenics Pharms Inc and AphelionThere are six patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-seven countries.

See drug price trends for PYLARIFY.

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

When can PYLARIFY TRUVU (piflufolastat f-18) generic drug versions launch in Taiwan?

Generic name: piflufolastat f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Taiwan Patent 200,836,765
Patent Title: Heterodimers of glutamic acid

PYLARIFY TRUVU is a drug marketed by Aphelion. There are six patents protecting this drug.

This drug has one hundred and sixteen patent family members in twenty-seven countries.

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

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Taiwan Patent 200,800,869
Patent Title: Precursor compound of radioactive halogen labeled organic compound

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

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

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

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Taiwan Patent I371439

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

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

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

When can ZYKADIA (ceritinib) generic drug versions launch in Taiwan?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Taiwan Patent 200,831,486
Patent Title: Compounds and compositions as protein kinase inhibitors

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

When can ZYKADIA (ceritinib) generic drug versions launch in Taiwan?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Taiwan Patent 201,124,402
Patent Title: Compounds and compositions as protein kinase inhibitors

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

When can ZYKADIA (ceritinib) generic drug versions launch in Taiwan?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Taiwan Patent I413641

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

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

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Taiwan Patent 200,831,102
Patent Title: 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use

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

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

See drug price trends for XERMELO.

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

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

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Taiwan Patent I412365

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

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

See drug price trends for XERMELO.

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

When can NESINA (alogliptin benzoate) generic drug versions launch in Taiwan?

Generic name: alogliptin benzoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Taiwan Patent 200,836,774
Patent Title: Solid preparation

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

This drug has sixty-nine patent family members in thirty-seven countries. There has been litigation on patents covering NESINA

See drug price trends for NESINA.

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

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch in Taiwan?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Taiwan Patent 201,350,143
Patent Title: Solid preparation

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

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

See drug price trends for OSENI.

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

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch in Taiwan?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Taiwan Patent I453041

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

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

See drug price trends for OSENI.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent 200,843,795
Patent Title: Stable digestive enzyme compositions

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent 201,422,233
Patent Title: Stable digestive enzyme compositions

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent I421090

PANCREAZE is a drug marketed by

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

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent 200,843,795
Patent Title: Stable digestive enzyme compositions

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent 201,422,233
Patent Title: Stable digestive enzyme compositions

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent I421090

ZENPEP is a drug marketed by

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

See drug price trends for ZENPEP.

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

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

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Taiwan Patent I406657

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

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

See drug price trends for XENLETA.

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

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

Generic name: azilsartan kamedoxomil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 28, 2027
Generic Entry Controlled by: Taiwan Patent I415634

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

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

See drug price trends for EDARBI.

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

When can VARUBI (rolapitant hydrochloride) generic drug versions launch in Taiwan?

Generic name: rolapitant hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 04, 2027
Generic Entry Controlled by: Taiwan Patent 200,815,439
Patent Title: Hydrochloride salts of 8-[{1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and preparation process therefor

VARUBI is a drug marketed by Tersera. There are eight patents protecting this drug.

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

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

When can INLYTA (axitinib) generic drug versions launch in Taiwan?

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Taiwan Patent 200,911,781
Patent Title: Novel crystalline forms of a VEGF-R inhibitor

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

This drug has ninety-seven patent family members in thirty countries. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the axitinib profile page.

When can INLYTA (axitinib) generic drug versions launch in Taiwan?

Generic name: axitinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Taiwan Patent I481602

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

This drug has ninety-seven patent family members in thirty countries. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the axitinib profile page.

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent 200,843,742
Patent Title: Novel pharmaceutical composition

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent 201,410,240
Patent Title: Pharmaceutical tablets, solid oral pharmaceutical dosage forms, pharmaceutical capsules and pharmaceutical granules comprising 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carbox

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent I439267

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

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

See drug price trends for PROMACTA.

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent I538674

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

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

See drug price trends for PROMACTA.

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

When can TRADJENTA (linagliptin) generic drug versions launch in Taiwan?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent 200,812,648
Patent Title: DPP IV inhibitor formulations

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

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

See drug price trends for TRADJENTA.

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

When can VRAYLAR (cariprazine hydrochloride) generic drug versions launch in Taiwan?

Generic name: cariprazine hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 11, 2027
Generic Entry Controlled by: Taiwan Patent I424846

Drug Price Trends for VRAYLAR
VRAYLAR is a drug marketed by Abbvie. There are five patents protecting this drug.

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

See drug price trends for VRAYLAR.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the cariprazine hydrochloride profile page.

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

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Taiwan Patent 200,906,437
Patent Title: Pasireotide formulation

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

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

See drug price trends for SIGNIFOR LAR.

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

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

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Taiwan Patent I412373

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

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

See drug price trends for SIGNIFOR LAR.

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

When can XADAGO (safinamide mesylate) generic drug versions launch in Taiwan?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2027
Generic Entry Controlled by: Taiwan Patent I393700

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

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

When can KYBELLA (deoxycholic acid) generic drug versions launch in Taiwan?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Taiwan Patent 200,918,550
Patent Title: Synthetic bile acid composition, method, and preparation

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch in Taiwan?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Taiwan Patent I503327

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can KYBELLA (deoxycholic acid) generic drug versions launch in Taiwan?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Taiwan Patent I503396

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

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

Generic name: aliskiren hemifumarate; hydrochlorothiazide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 22, 2027
Generic Entry Controlled by: Taiwan Patent 200,808,358

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 BYDUREON (exenatide synthetic) generic drug versions launch in Taiwan?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,406,743
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for BYDUREON.

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,546,054
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,406,743
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,546,054
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four suppliers are listed for this generic product. Additional details are available on the dapagliflozin profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch in Taiwan?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent I421245

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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. Twenty-four 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 in Taiwan?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,406,743
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent 201,546,054
Patent Title: Crystal structures of SGLT2 inhibitors and processes for preparing same

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

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

See drug price trends for QTERN.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2027
Generic Entry Controlled by: Taiwan Patent I421245

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

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

See drug price trends for QTERN.

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

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 06, 2027
Generic Entry Controlled by: Taiwan Patent 200,811,167
Patent Title: Modulators of pharmacokinetic properties of therapeutics

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Taiwan?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 06, 2027
Generic Entry Controlled by: Taiwan Patent 201,412,733
Patent Title: Modulators for improving pharmacokinetic properties of therapeutics metabolized by cytochrome P450 monooxygenase

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Taiwan?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Taiwan Patent I501768

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

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

When can KAZANO (alogliptin benzoate; metformin hydrochloride) generic drug versions launch in Taiwan?

Generic name: alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 19, 2027
Generic Entry Controlled by: Taiwan Patent 200,914,066
Patent Title: Solid preparation

Drug Price Trends for KAZANO
KAZANO is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in forty-one countries. There has been litigation on patents covering KAZANO

See drug price trends for KAZANO.

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

When can KAZANO (alogliptin benzoate; metformin hydrochloride) generic drug versions launch in Taiwan?

Generic name: alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 19, 2027
Generic Entry Controlled by: Taiwan Patent I421102

Drug Price Trends for KAZANO
KAZANO is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety patent family members in forty-one countries. There has been litigation on patents covering KAZANO

See drug price trends for KAZANO.

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

When can RELISTOR (methylnaltrexone bromide) generic drug versions launch in Taiwan?

Generic name: methylnaltrexone bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 30, 2027
Generic Entry Controlled by: Taiwan Patent 200,815,007

Drug Price Trends for RELISTOR
RELISTOR is a drug marketed by Salix Pharms and SalixThere are twelve patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for RELISTOR.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the methylnaltrexone bromide profile page.

When can RELISTOR (methylnaltrexone bromide) generic drug versions launch in Taiwan?

Generic name: methylnaltrexone bromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 30, 2027
Generic Entry Controlled by: Taiwan Patent I489984

Drug Price Trends for RELISTOR
RELISTOR is a drug marketed by Salix Pharms and SalixThere are twelve patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

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

See drug price trends for RELISTOR.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the methylnaltrexone bromide profile page.

When can BRILINTA (ticagrelor) generic drug versions launch in Taiwan?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent I482772

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are two patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has sixty-two patent family members in thirty-five countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

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

When can INTRAROSA (prasterone) generic drug versions launch in Taiwan?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent 201,212,922
Patent Title: DHEA compositions for treating menopause

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

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

When can INTRAROSA (prasterone) generic drug versions launch in Taiwan?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent 201,634,051
Patent Title: DHEA compositions for treating menopause

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

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

When can INTRAROSA (prasterone) generic drug versions launch in Taiwan?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent I388328

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

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

When can INTRAROSA (prasterone) generic drug versions launch in Taiwan?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent I565468

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

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

When can INTRAROSA (prasterone) generic drug versions launch in Taiwan?

Generic name: prasterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 10, 2027
Generic Entry Controlled by: Taiwan Patent I609688

Drug Price Trends for INTRAROSA
INTRAROSA is a drug marketed by Millicent. There are three patents protecting this drug.

This drug has fifty-nine patent family members in thirty-two countries. There has been litigation on patents covering INTRAROSA

See drug price trends for INTRAROSA.

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

Last updated: May 12, 2026

Taiwan Branded vs Generic Drug Markets Assessment and Regulatory Opportunities and Challenges (2026)

Taiwan’s prescription drug market remains dominated by branded and branded generics within Taiwan’s National Health Insurance (NHI) reimbursement framework, with generic substitution and price competition constrained by reimbursement rules, reference pricing mechanics, and product-specific interchangeability and labeling constraints. Regulatory opportunities cluster around (1) faster time-to-market via Taiwan’s ANDA-type pathways, (2) lifecycle strategies that preserve reimbursement positioning, and (3) product line expansion through formulation and pack-size differentiation that fit NHI reimbursement categories. Key challenges are pricing pressure from NHI, tight clinical evidence expectations when modifying active ingredients or dosing regimens, data exclusivity and patent/regulatory linkage risk where applicable, and supply-chain scrutiny for manufacturing transfers and batch release.

How big are Taiwan’s branded vs generic drug markets and what drives share?

Taiwan’s outpatient and inpatient prescription drug spend is channeled through NHI reimbursement, which strongly shapes market share. Branded products typically retain higher share when they secure favorable reimbursement status, maintain formulary access, and benefit from physician familiarity and patient switching inertia. Generic penetration increases when NHI reference pricing compresses reimbursed prices and when multiple products obtain reimbursement clearance that supports substitution.

Market structure by product type

Branded (originator and branded new chemical entities):

  • Higher penetration in therapy classes with limited generic availability, fewer equivalent products, or stronger reimbursement placement for specific strengths/dosages.
  • Maintenance tied to NHI reimbursement listing, continued pricing contracts, and manufacturability.

Generics (including branded generics):

  • Competitive pressure concentrates on molecules where multiple generics launch and where NHI reference pricing forces price convergence.
  • Share rises when pharmacists and physicians have clear substitution pathways and when generics match dose strength and dosage form expectations.

What drives branded vs generic differentiation in Taiwan?

  • NHI listing status and reimbursement category: Access and relative reimbursement levels determine effective net pricing.
  • Reference pricing and tender-like behavior in practice: NHI reimbursement pricing frameworks reduce price dispersion over time.
  • Physician prescribing habits: Clinical comfort and perceived quality reduce switching velocity early post-generic launch.
  • Supply reliability and inspection outcomes: Manufacturing quality and batch release stability influence continued dispensing.
  • Lifecycle claims and differentiation: Fixed-dose combinations, specific dosing regimens, or formulation improvements can delay direct price compression.

What is the Taiwan regulatory pathway for generic entry and how does it differ from branded approvals?

Taiwan’s regulatory pathway is agency-driven and product-specific, with submission content requirements scaling by product type and whether the application is for a new active ingredient, a change in formulation, or a generic/“follow-on” product.

Submission and evidence patterns that matter for market entry

Branded (new active ingredients or new marketing authorization applications):

  • Requires full quality, nonclinical, and clinical packages commensurate with a new dossier.
  • Often includes robust clinical evidence to support safety and efficacy and to secure reimbursement positioning.

Generics/follow-on products:

  • Typically require demonstration of pharmaceutical equivalence and bioequivalence for eligible strengths/dosages/dosage forms.
  • Clinical evidence is generally reduced compared with reference products, but expectations remain stringent when:
    • there is complexity in formulation (for example, extended release),
    • there are narrow therapeutic window considerations,
    • there are changes impacting absorption.

Practical regulatory timing drivers

  • Bioequivalence package completeness: Study design, reference product selection, and analytical method validation drive review speed.
  • CMC alignment: Taiwan authorities scrutinize manufacturing consistency, validation, and comparability.
  • Label and postmarketing commitments: Labeling alignment with reference product claims affects substitution and physician comfort.

What are Taiwan’s data exclusivity and patent/regulatory linkage constraints for generics?

Taiwan’s environment includes both patent enforcement risk and regulatory blocking dynamics. In practice, generic entry can be delayed by:

  • active patent estates that cover composition, method of use, or formulation,
  • regulatory submissions that trigger patent-related disputes and enforcement actions,
  • and settlement structures that limit launch or delay specific strengths.

Typical patent estate coverage patterns relevant to Taiwan filings

  • Composition-of-matter patents for active ingredient and salts.
  • Formulation patents for dosage forms, release profiles, and excipient systems.
  • Method-of-use patents for new indications or treatment regimens.
  • Process/manufacturing patents that can complicate CMC transfers and launch strategy.

Litigation and settlement mechanics that affect launch timing

  • Patent enforcement in Taiwan can lead to injunction risk.
  • Settlement agreements in global strategies often extend into product launch timing, sometimes with agreed launch dates or supply restrictions.

What is the Orange Book status in Taiwan and where do products get listed for reimbursement?

Taiwan does not use the US “Orange Book” construct in name, but it does maintain structured systems for reimbursement listing that affect pricing and market access. For market entry planning, the operative question is not whether a product appears in an Orange Book equivalent, but whether it is:

  • reimbursed by NHI for the relevant indication,
  • listed at a price level that supports volume,
  • and eligible for substitution in the context of pharmacy dispensing.

How reimbursement listing shapes effective exclusivity

  • Branded products can retain higher effective exclusivity via:
    • continued NHI listing with favorable reimbursement status,
    • limited generic competition for specific strengths/dosage forms,
    • and lifecycle differentiation that keeps reimbursement alignment favorable.
  • Generics accelerate penetration when multiple reimbursed products exist at or near reference pricing.

When does Taiwan drug exclusivity end and how is exclusivity measured in practice?

Taiwan exclusivity outcomes are driven by a combination of:

  • market authorization timelines and regulatory exclusivity structures,
  • NHI reimbursement positioning,
  • and patent enforcement status.

Practical exclusivity timeline concept

For planning, exclusivity is best treated as a blended window:

  • Regulatory market exclusivity window: time before follow-on products can rely on reduced dossiers (where applicable).
  • Patent-life and enforcement window: time during which enforcement can block launch.
  • Reimbursement and reference-price window: time during which branded net price remains protected by reimbursement rules and lack of equivalent substitutes.

Why patent dates do not equal market authorization dates in Taiwan

Even after patent expiry, NHI reimbursement mechanics and CMC/BE requirements can keep brands competitive. Conversely, some generic launch can occur earlier if patent posture and reimbursement timing align.

Which therapy areas are most attractive for generic and biosimilar opportunities in Taiwan?

Generic demand grows where multiple equivalent products can be approved and where NHI reimbursement compresses prices across a class. Biosimilar opportunities are concentrated in:

  • high-cost biologics with established clinical use and broad prescribing,
  • classes where reference product patents and data exclusivity have cleared or can be navigated via transition strategies.

Attraction factors by therapeutic category

  • Chronic therapy classes with high patient volumes: statins, antihypertensives, diabetes, gastrointestinal agents.
  • Oncology supportive care where substitution is easier: antiemetics, analgesics, supportive infusions.
  • Vaccines and biologics where biosimilar adoption requires manufacturing and immunogenicity confidence plus physician acceptance.

What formulation and manufacturing changes are the highest-risk regulatory moves for Taiwan generic launches?

CMC risk determines whether review slows, whether approval is delayed, or whether product substitution becomes harder.

High-risk formulation change scenarios

  • Switching from one release mechanism to another (for example, IR to ER) without full bridge evidence.
  • Changing excipient compositions in ER products.
  • Narrow therapeutic window products where small changes can shift exposure.
  • Modifications that could change particle size or dissolution profile without bridging.

High-risk manufacturing transfer scenarios

  • Moving manufacturing sites or scale-ups without full comparability packages.
  • Batch release parameter changes affecting potency, impurities, sterility assurance, or stability.
  • Inadequate stability data supporting shelf-life at distribution temperatures.

How does Taiwan enforce pharmacovigilance and what post-approval obligations affect commercialization?

Post-approval obligations influence ongoing costs, timeline risk, and willingness to launch.

Common postmarketing operational requirements

  • Periodic safety update reporting with Taiwan-specific timelines.
  • Signal detection and risk management plans for higher-risk products.
  • Product quality complaint handling and batch-level traceability.
  • Label updates when safety information changes.

Commercial impact of pharmacovigilance

  • Strong PV programs support continued reimbursement listing.
  • Safety signal events can trigger label restrictions that reduce switching and substitution uptake.

What are the key regulatory opportunities in Taiwan for new entrants and life-cycle products?

Taiwan offers entry opportunities through both molecule expansion and lifecycle tactics aligned to reimbursement categories.

Opportunity clusters

1) Fast generic development for straightforward bioequivalence molecules

  • Plain IR products with high BE probability have the cleanest paths to approval and substitution.

2) Lifecycle differentiation that preserves NHI reimbursement positions

  • Strength-specific launches that match reimbursed strengths.
  • Pack-size strategies that improve dispensing economics.
  • Formulation improvements that qualify for separate reimbursement if recognized by NHI category mechanisms.

3) Manufacturing and quality leadership as an accelerant

  • Lower inspection failure risk and faster batch release support smoother scaling.

4) Strategy for staggered launch across strengths

  • Enter with the most reimbursed or highest-volume strength first, then add additional strengths contingent on reimbursement and BE outcomes.

Where do regulatory challenges concentrate for foreign sponsors and local manufacturers?

For cross-border development, challenges cluster in the interfaces between CMC documentation, inspection readiness, and local compliance.

Sponsor-side challenges

  • Building a CMC package that matches Taiwan expectations for comparability and validation.
  • Ensuring local labeling and promotional materials conform to Taiwan claims standards.
  • Managing PV staffing and language requirements.

Local manufacturing and inspection challenges

  • GMP readiness aligned with Taiwan inspection schedules.
  • Timely batch release and stability program credibility.
  • Correct handling of variations and annual report submissions.

What generic entry risks exist for specific brands in Taiwan: patent, BE, and reimbursement?

Generic entry risk is best modeled as three gates:

  1. Legal gate (patent status and potential enforcement),
  2. Scientific gate (bioequivalence and BE bridging),
  3. Economic gate (NHI reimbursement eligibility and price positioning).

Patent gate

  • If a brand has an active formulation or method-of-use patent, a generic may need to design around claims or accept litigation risk.
  • Multiple patents across different jurisdictions often correlate with more complex enforcement in practice.

BE gate

  • ER, transdermal, and complex dissolution products have higher BE study design risk.
  • If BE results fail to demonstrate equivalence, approvals can be delayed or restricted.

Reimbursement gate

  • Even with regulatory approval, reimbursement listing determines commercial viability.
  • Price setting and reference pricing can eliminate profitability if reimbursement entry occurs late.

How do settlement agreements and launch carve-outs typically play out in Taiwan?

When patent litigation intersects with generic submissions, settlement agreements can:

  • fix launch dates for certain strengths,
  • restrict supply volumes,
  • or allow launch for some strengths while delaying others tied to specific patent claims.

Commercial mechanics

  • Settlements reduce uncertainty around approval-to-launch pathways.
  • They can also lock in market share by controlling early supply and substitution timing.

Which companies are best positioned to compete in Taiwan’s generic market and why?

Competitive positioning typically depends on:

  • breadth of product portfolio with BE-ready dossiers,
  • scale in manufacturing and quality systems,
  • reimbursement access capabilities,
  • and litigation management capacity.

Why incumbents often maintain share

  • Brand and branded generics teams have entrenched NHI listing relationships.
  • Early generics can suffer if supply chains and PV obligations are weak, enabling follow-on entrants.

How does Taiwan compare with US/EU regulation for generics and market exclusivity?

Regulatory similarity: Both Taiwan and Western regulators require pharmaceutical equivalence and bioequivalence for generics in eligible cases.

Key differences:

  • Taiwan’s reimbursement and substitution environment is tightly coupled to NHI listing mechanisms, which can matter as much as approval.
  • Lifecycle management and reimbursement category selection can create practical “exclusivity-like” effects even after patent expiry.

Commercial comparability

  • US exclusivity is often analyzed through Orange Book exclusivity and patent expiration.
  • Taiwan market entry is better modeled through the combined lens of patent posture plus NHI reimbursement category and pricing behavior.

Key Takeaways

  • Taiwan’s branded vs generic market is shaped primarily by NHI reimbursement listing, reference pricing behavior, and substitution dynamics.
  • Generic regulatory entry is feasible when BE and CMC packages are strong, but launch viability still depends on NHI reimbursement eligibility and price positioning.
  • Patent estates (composition, formulation, method of use) and enforcement outcomes can delay generic launches even after regulatory pathways are technically available.
  • The highest-value opportunities target molecules with straightforward BE risk, scalable CMC readiness, and a reimbursement plan that matches strengths and dosage forms already supported by NHI.
  • Lifecycle and formulation differentiation can preserve branded competitiveness by maintaining favorable reimbursement positioning longer than patent expiry timelines alone suggest.

FAQs

  1. How does NHI reimbursement listing affect whether an approved generic succeeds in Taiwan?
  2. What types of dosage forms have the highest bioequivalence study risk for Taiwan generic approvals?
  3. How do formulation patents in Taiwan typically restrict generic substitution or strength-by-strength entry?
  4. What postmarketing pharmacovigilance obligations are most likely to impact launch timelines in Taiwan?
  5. What manufacturing transfer changes most often trigger comparability gaps during Taiwan regulatory review?

References (APA)

  1. U.S. Food and Drug Administration. (n.d.). Bioequivalence and related guidance documents. FDA. https://www.fda.gov/
  2. World Health Organization. (n.d.). WHO guidance on pharmacovigilance and quality systems. WHO. https://www.who.int/
  3. European Medicines Agency. (n.d.). Guideline on bioequivalence and pharmacoepidemiology. EMA. https://www.ema.europa.eu/
  4. National Health Insurance Administration (Taiwan). (n.d.). Reimbursement-related program information. NHIA. https://www.nhi.gov.tw/

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