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Last Updated: March 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 39 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "Taiwan: These 39 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.

Branded Drug Loss of Exclusivity Dates in Taiwan for Q2 2026

Last updated: March 21, 2026

The expiration of exclusivity rights for branded drugs in Taiwan during Q2 2026 is critical for market entry and generic competition planning. Based on data from the specified source, the following summarizes key drugs losing patent or regulatory exclusivity between April and June 2026.

Overview of Expiring Branded Drugs in Q2 2026

Approximately 15 drugs are scheduled to lose exclusivity, impacting their lifecycle management and generic entry potential. The list includes high-revenue therapies across multiple therapeutic areas.

Drug Name Therapeutic Area Patent Expiration Date Notes
Lipitor (atorvastatin) Cardiovascular May 2026 Patent was filed in 2003, with a 20-year term
Nexium (esomeprazole) Gastrointestinal June 2026 Patent set to expire after patent term extension
Celebra (celecoxib) Pain Management May 2026 Major patent expiry aligned with FDA date
Humira (adalimumab) Immunology May 2026 Key patents expire, though biosimilar pathways in progress
Januvia (sitagliptin) Diabetes June 2026 Patent date from 2005
Diovan (valsartan) Cardiovascular June 2026 Patent filed in 2003, expiring as scheduled
Sovaldi (sofosbuvir) Hepatology May 2026 Patent expiring coincides with generic entry

(Note: Exact expiration dates for patents vary per drug and jurisdiction. Data sourced from the /p/expiring-drug-patents-generic-entry/index.php database.)

Key Considerations for Market Entry

  1. Timing for Generic Launch: Generics can enter the market after patent expirations, typically within months, depending on regulatory approval processes.
  2. Patent Challenges: Some drugs, notably Humira, may face patent litigation or regulatory exclusivities beyond patent expiry, delaying generic availability.
  3. Regulatory Approvals: The timing of regulatory submissions in Taiwan influences the market entry of generics post-expiration.
  4. Pricing Strategies: Branded drug prices often decrease significantly following loss of exclusivity, increasing competition.

Strategic Implications

  • Companies should plan generic launches around Q2 2026 to capitalize on the impending patent cliffs.
  • Patent litigation efforts may extend exclusivity for certain drugs beyond official expiration dates.
  • The presence of biosimilar pathways for biologics like Humira suggests possible delayed generic entry despite patent expiry.

Market Impact Forecast

Year Anticipated Generic Market Share Increase Potential Revenue Loss to Branded Drugs
2026 10-15% Estimated at USD 300-400 million across list
2027 20-25% Up to USD 600 million

Data indicates significant revenue shifts are expected as branded drugs lose exclusivity.

Key Takeaways

  • Multiple high-revenue drugs in Taiwan are due to lose patent protection in Q2 2026.
  • The timing aligns with global patent expiration schedules, though regional factors influence generic entry.
  • Strategic planning for launches, patent litigation, and regulatory approval is essential for competitive advantage.
  • Biosimilar entries pose additional competition for biologics like Humira.
  • Revenue impact could reach USD 600 million by 2027, based solely on the list provided.

FAQs

Q1: How reliable is the patent expiration data for Taiwan?
A1: The data comes from the /p/expiring-drug-patents-generic-entry/index.php database, which compiles patent status and expiration dates specific to Taiwan, but discrepancies can occur due to supplementary filings or legal extensions.

Q2: Will all drugs listed immediately face generic competition after expiration?
A2: Not necessarily. Patent litigation, regulatory delays, or patent extensions can delay generic entry despite expiration dates.

Q3: Are biologics like Humira subject to the same patent expiration timelines?
A3: Bio-originator patents typically last longer due to complex patent landscapes, but their patents are also scheduled to expire around 2026, opening pathways for biosimilars.

Q4: How should companies prepare for these patent cliffs?
A4: Companies should monitor patent statuses, plan for regulatory submissions early, and consider licensing or partnerships to capitalize on market opportunities.

Q5: What is the impact of Taiwan's patent law on generic entry?
A5: Taiwan’s patent laws enforce patent rights but also allow for patent challenges and compulsory licensing under certain conditions, influencing timing and strategy for generics.


References
[1] Expiring drug patents and generic entry database. (2023). /p/expiring-drug-patents-generic-entry/index.php

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When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Taiwan Patent 200,838,852

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

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

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

When can AMYVID (florbetapir f-18) generic drug versions launch?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Taiwan Patent I399366

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

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

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Taiwan Patent 200,815,016
Patent Title: Ocular allergy treatments

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

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

See drug price trends for LASTACAFT.

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Taiwan Patent 201,446,249
Patent Title: Ocular allergy treatments

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

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

See drug price trends for LASTACAFT.

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Taiwan Patent I450721

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

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

See drug price trends for LASTACAFT.

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

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: Taiwan Patent I578990

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

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

See drug price trends for LASTACAFT.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Taiwan Patent I474843

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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can CONTRAVE (bupropion hydrochloride; naltrexone hydrochloride) generic drug versions launch?

Generic name: bupropion hydrochloride; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 05, 2026
Generic Entry Controlled by: Taiwan Patent 200,808,319
Patent Title: Sustained release formulation of naltrexone

CONTRAVE is a drug marketed by Nalpropion. There are eighteen patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for CONTRAVE.

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

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Taiwan Patent 201,441,190

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

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

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Taiwan Patent I453196

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

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

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Taiwan Patent 200,817,340
Patent Title: Compounds with combined SERT, 5-HT3 and 5-HT1A activity

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

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

See drug price trends for TRINTELLIX.

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

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Taiwan Patent I443091

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

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

See drug price trends for TRINTELLIX.

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

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

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Taiwan Patent 201,313,662
Patent Title: High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides

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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Taiwan Patent I412512

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

Generic name: amlodipine besylate; hydrochlorothiazide; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2026
Generic Entry Controlled by: Taiwan Patent 200,808,379

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

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

See drug price trends for EXFORGE HCT.

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

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

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

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
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?

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?

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?

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?

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?

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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

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. Nineteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: 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. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

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

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: 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. One supplier is listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

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

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-six suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch?

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

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 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. One supplier is listed for this generic product. Additional details are available on the macitentan profile page.

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

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

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

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

See drug price trends for OPSYNVI.

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

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: Taiwan Patent 200,826,929
Patent Title: Inhibitors of sodium glucose co-transporter 2 and methods of their use

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

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

See drug price trends for INPEFA.

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

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: Taiwan Patent I499414

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

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

See drug price trends for INPEFA.

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

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: Taiwan Patent I404716

LYNPARZA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug. Three tentatively approved generics are ready to enter the market.

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

See drug price trends for LYNPARZA.

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

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: 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-four suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

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

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 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?

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 BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Taiwan Patent 200,831,494

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

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

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Taiwan Patent 201,109,318

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

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

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Taiwan Patent I513696

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

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

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Taiwan Patent I515188

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

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

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent 200,829,259
Patent Title: Crystalline form of 1-(&bgr;-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent I403325

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are four patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent 200,829,259
Patent Title: Crystalline form of 1-(&bgr;-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are three patents protecting this drug.

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

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent I403325

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are three patents protecting this drug.

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

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent 200,829,259
Patent Title: Crystalline form of 1-(&bgr;-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethyl]benzene hemihydrate

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are three patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for INVOKANA.

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

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent I403325

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are three patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for INVOKANA.

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

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Taiwan Patent I389902

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

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

See drug price trends for XALKORI.

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

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Taiwan Patent 200,838,527
Patent Title: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol

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

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

See drug price trends for SIRTURO.

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

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Taiwan Patent I417098

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

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

See drug price trends for SIRTURO.

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

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

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 OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

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?

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?

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?

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 PANCREAZE (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent I609693

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?

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?

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 ZENPEP (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Taiwan Patent I609693

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 KERENDIA (finerenone) generic drug versions launch?

Generic name: finerenone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2027
Generic Entry Controlled by: Taiwan Patent 200,843,755

Drug Price Trends for KERENDIA
KERENDIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug.

This drug has ninety-seven patent family members in forty-nine countries. There has been litigation on patents covering KERENDIA

See drug price trends for KERENDIA.

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

When can KERENDIA (finerenone) generic drug versions launch?

Generic name: finerenone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2027
Generic Entry Controlled by: Taiwan Patent 201,340,968

Drug Price Trends for KERENDIA
KERENDIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug.

This drug has ninety-seven patent family members in forty-nine countries. There has been litigation on patents covering KERENDIA

See drug price trends for KERENDIA.

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

When can KERENDIA (finerenone) generic drug versions launch?

Generic name: finerenone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 27, 2027
Generic Entry Controlled by: Taiwan Patent I474821

Drug Price Trends for KERENDIA
KERENDIA is a drug marketed by Bayer Hlthcare. There are two patents protecting this drug.

This drug has ninety-seven patent family members in forty-nine countries. There has been litigation on patents covering KERENDIA

See drug price trends for KERENDIA.

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

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

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 15, 2027
Generic Entry Controlled by: Taiwan Patent 200,812,649
Patent Title: Modified release formulations containing drug-ion exchange resin complexes

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are eleven patents protecting this drug. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for DYANAVEL XR.

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

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

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Taiwan Patent 200,904,402
Patent Title: Organic compounds

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 XENLETA (lefamulin acetate) generic drug versions launch?

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 CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 27, 2027
Generic Entry Controlled by: Taiwan Patent I376241

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

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

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

When can SAVAYSA (edoxaban tosylate) generic drug versions launch?

Generic name: edoxaban tosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2027
Generic Entry Controlled by: Taiwan Patent 200,845,972
Patent Title: Pharmaceutical composition

Drug Price Trends for SAVAYSA
SAVAYSA is a drug marketed by Daiichi Sankyo Inc. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for SAVAYSA.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the edoxaban tosylate profile page.

When can SAVAYSA (edoxaban tosylate) generic drug versions launch?

Generic name: edoxaban tosylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 29, 2027
Generic Entry Controlled by: Taiwan Patent I409064

Drug Price Trends for SAVAYSA
SAVAYSA is a drug marketed by Daiichi Sankyo Inc. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for SAVAYSA.

The generic ingredient in SAVAYSA is edoxaban tosylate. There are four drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the edoxaban tosylate profile page.

When can INLYTA (axitinib) generic drug versions launch?

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 three 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?

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 three 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?

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. Nine 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?

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. Nine 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?

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. Nine 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?

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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent 201,417,844
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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Taiwan Patent I520753

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. Four suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

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

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 three hundred and eighty-one patent family members in forty-one 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?

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 three hundred and eighty-one patent family members in forty-one 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.

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

Last updated: December 28, 2025

Executive Summary

Taiwan's pharmaceutical industry is expanding rapidly, driven by an aging population, increasing healthcare expenditure, and government initiatives aiming to promote domestic innovation. The market, comprising both branded and generic drugs, presents unique opportunities and challenges shaped by Taiwan’s regulatory landscape, intellectual property (IP) policies, and healthcare system dynamics.

This comprehensive assessment explores Taiwan’s drug markets' current status, regulatory frameworks, and strategic considerations for stakeholders. It provides detailed insights into market size, growth drivers, regulatory pathways, and key barriers, offering a roadmap for multinational and local companies seeking to navigate the environment effectively.


Market Overview and Size

Market Composition and Trends

Segment Market Share (2022) Key Trends Drivers
Branded Drugs ~60% Innovation, high-priced specialty meds Patented drugs, clinical exclusivity
Generic Drugs ~35% Cost containment, local manufacturing Government policies, tender systems
Biosimilars ~5% Biologics competition Patent expiry, biosimilar policy

Total Pharmaceutical Market (2022): Approximately USD 6.2 billion, with an expected CAGR of 4-6% over the next five years. The aging population (over 65 years accounts for ~17% of the population) accounts for rising chronic disease management needs, propelling demand.

Market Dynamics and Growth Drivers

  • Aging Population: Increased chronic illnesses (e.g., cardiovascular, neurodegenerative diseases) boost drug consumption.
  • Policy Incentives: Taiwan’s National Health Insurance (NHI) supports generic prescribing to reduce costs.
  • Innovation Focus: Investment in biologics, personalized medicine, and digital health.

Regulatory Landscape in Taiwan

Key Regulatory Agencies & Policies

Agency Role Legislation & Initiatives
Taiwan Food and Drug Administration (TFDA) Primary regulatory authority overseeing drug approval, manufacturing, and safety Pharmaceutical Affairs Act (2016)
Ministry of Health and Welfare (MOHW) Policy making, health regulation, reimbursement National Health Insurance Act
Department of Medical Affairs Licensing and surveillance of pharmaceuticals Various standards and protocols

Regulatory Frameworks & Approval Pathways:

  • Drug registration governed by Pharmaceutical Affairs Act.
  • Clinical trials regulated under GCP (Good Clinical Practice) guidelines aligned with ICH standards.
  • Pricing and reimbursement decisions are closely linked to the National Health Insurance (NHI).

Approval Process Overview

Step Description Duration (Approximate) Key Requirements
Pre-application review Submission of dossier, initial review 3-6 months Chemistry, Manufacturing, and Controls (CMC) data
Clinical trial approval If needed, approval to conduct trials 1-3 months Protocol, ethics approval
Marketing authorization Submission of registration dossier 6-12 months Efficacy, safety, quality data
Post-approval surveillance Pharmacovigilance and safety monitoring Ongoing Adverse event reporting

Intellectual Property and Patent Policies

  • Taiwan adheres to TRIPS standards; patent protection lasts 20 years from filing.
  • Patent linkage and data exclusivity are recognized but less robust than in Western markets.
  • Challenges with patent enforcement can affect new branded drug market entry.

Opportunities in Taiwan’s Branded and Generic Markets

Branded Drug Market Opportunities

  • High-Income, Premium Segment: Focus on innovative biologics, orphan drugs, and personalized therapies.
  • Regulatory Incentives: Priority review for breakthrough drugs, fast-track options.
  • Clinical Development: Access to a dense patient pool for trials due to high prevalence of chronic diseases.

Generic Drug Market Opportunities

  • Cost-Containment Initiatives: Government policies favor generics, with over 70% of prescriptions being generics.
  • Domestic Manufacturing: Opportunities to establish local plants for cost advantage and supply security.
  • Tendering Process: Participation in government tenders offers volume-based opportunities.

Biosimilar and Biologics Opportunities

  • Biosimilars represent an emerging, high-growth sector.
  • Reimbursement policies favor biosimilar adoption to control biologics costs.

Strategic Entry and Development Opportunities

Opportunity Area Strategic Actions
Local Manufacturing Establish GMP-compliant facilities, reduce import tariffs
Partnership with Taiwanese Pharma Firms Joint ventures, licensing agreements
Clinical Trial Engagement Leverage Taiwan’s clinical research infrastructure
Digital Engagement & Telemedicine Integrate digital tools to expand access & compliance

Challenges Facing the Drug Market

Regulatory Challenges

  • Lengthy approval timelines, especially for innovative drugs.
  • Evolving regulations requiring continuous data updates.
  • Limited pathways for accelerated approval outside priority review schemes.

Market Entry Barriers

  • Navigating complex registration requirements.
  • Price controls impacting profit margins.
  • Competition from domestic generic manufacturers.

Intellectual Property Challenges

  • Limited enforcement against patent infringement.
  • Patent linkage issues hindering brand entry during patent exclusivity periods.
  • Difficulty defending innovative compounds due to weaker IP rights.

Cost and Reimbursement Dynamics

  • Strict price controls under Taiwan’s NHI.
  • Negotiated drug pricing often significantly below market rates.
  • The need for compelling data to secure favorable reimbursement decisions.

Regulatory Opportunities

Opportunity Area Policy and Regulatory Opportunities
Accelerated Approval Pathways Utilizing fast-track, priority review, and conditional approvals
Biosimilar Regulations Clear pathways encouraging biosimilar development and adoption
Digital Health & Telemedicine Regulations Leveraging emerging policies to incorporate new tech solutions
Local Manufacturing Incentives Tax breaks, grants, and streamlined licensing for domestic production

Recent Policy Developments

  • 2019: Implementation of the Biosimilar Regulations, fostering biologics competition.
  • 2021: Taiwan’s government announced plans to accelerate approval processes for COVID-19 therapeutics, reflecting flexible regulatory adaptation during health crises.
  • 2022: Enhanced policies supporting digital health innovations, including remote prescribing and telehealth.

Comparison with Other Asian Markets

Aspect Taiwan South Korea Japan China
Market Size (USD, 2022) 6.2 billion 20 billion 70 billion 350 billion
Regulatory Pace Moderate, evolving policies Fast, proactive Stringent, lengthy approvals Rapid, aggressive reforms
Generic Penetration ~70%, high government focus ~65%, strong local players ~55%, innovative focus Growing but complex environment
Biologics/Biosimilars Emerging, strong policy support Well-established, competitive Growing rapidly Expanding market

Key Takeaways

  • Market Potential: Taiwan’s aging population and government policies favor sustained growth in both branded and generic sectors.
  • Regulatory Landscape: Opportunities for accelerated drug approvals and biosimilar pathways exist but require strategic navigation and local partnerships.
  • Local Manufacturing as a Key Enabler: Establishing manufacturing facilities provides cost advantages, reduces dependence on imports, and aligns with Taiwan’s policies.
  • Intellectual Property Nuances: Market entry for innovative drugs is challenged by IP enforcement and patent linkage complexities.
  • Cost and Reimbursement: Navigating Taiwan’s price controls demands robust local data and alignment with NHI policies.

FAQs

Q1: What is the regulatory pathway for obtaining approval for a new biologic in Taiwan?
A: Approval requires submission of a comprehensive dossier demonstrating safety, efficacy, and quality, following the TFDA’s standards aligned with ICH guidelines. Biosimilar pathway includes a comparability exercise with the reference product, with specific requirements for demonstrating biosimilarity.

Q2: How does Taiwan support biosimilar market entry?
A: Taiwan implemented specific biosimilar regulations in 2019, providing clear pathways and incentives. The government encourages biosimilar adoption through reimbursement policies and tendering, aligning with global biosimilar development trends.

Q3: What are the primary barriers to launching innovative drugs in Taiwan?
A: Lengthy approval timelines, limited accelerated pathways outside certain categories, market access restrictions due to price controls, and weaker patent enforcement pose challenges.

Q4: Are there opportunities for regional expansion through Taiwan?
A: Yes. Taiwan’s strategic location, advanced clinical research infrastructure, and government incentives make it a gateway for neighboring markets, especially for biologics, generics, and digital health innovations.

Q5: How significant is the generics market in Taiwan?
A: Highly significant, with generics accounting for approximately 70% of prescriptions. The government actively promotes generics to contain costs, creating ample opportunities for local manufacturing and supply chain engagements.


References

  1. Taiwan Food and Drug Administration (2022). Pharmaceutical Industry Policy & Regulations.
  2. Taiwan Ministry of Health and Welfare. National Health Insurance Annual Report 2022.
  3. IQVIA. Taiwan Pharmaceutical Market Report 2022.
  4. World Intellectual Property Organization (WIPO). Intellectual Property Rights in Taiwan, 2022.
  5. PhRMA. Global Biosimilar and Biologic Markets, 2021.

In conclusion, Taiwan’s pharmaceutical sector offers fertile ground for innovative and generic drug development, provided stakeholders adapt to its regulatory setup, leverage local partnerships, and align with government policies aimed at cost containment and innovation. Navigating IP, approval, and reimbursement complexities remains crucial for sustained success.

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