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Pirfenidone Patent Expiration

Pirfenidone is used for treating idiopathic pulmonary fibrosis. It was first introduced by Genentech Inc in its drug Esbriet on Oct 15, 2014. 15 different companies have introduced drugs containing Pirfenidone.


Pirfenidone Patents

Given below is the list of patents protecting Pirfenidone, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Esbriet US10188637 Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Mar 28, 2037 Genentech Inc
Esbriet US8778947 Methods of administering pirfenidone therapy Aug 30, 2033 Genentech Inc
Esbriet US7816383 Methods of administering pirfenidone therapy Jan 08, 2030 Genentech Inc
Esbriet US7910610 Methods of administering pirfenidone therapy Jan 08, 2030 Genentech Inc
Esbriet US8013002 Methods of administering pirfenidone therapy Jan 08, 2030 Genentech Inc
Esbriet US8084475 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Genentech Inc
Esbriet US8318780 Methods of administering pirfenidone therapy Jan 08, 2030 Genentech Inc
Esbriet US8648098 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Genentech Inc
Esbriet US8754109 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Genentech Inc
Esbriet US7566729 Modifying pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Genentech Inc
Esbriet US7635707 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Genentech Inc
Esbriet US8592462 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Genentech Inc
Esbriet US8609701 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Genentech Inc
Esbriet US8383150 Granulate formulation of pirfenidone and pharmaceutically acceptable excipients May 10, 2028 Genentech Inc
Esbriet US7696236 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Genentech Inc
Esbriet US7696326 Multiple antigen glycopeptide carbohydrate, vaccine comprising the same and use thereof Dec 18, 2027 Genentech Inc
Esbriet US7767700 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Genentech Inc
Esbriet US8420674 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Genentech Inc
Esbriet US7767225 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026 Genentech Inc
Esbriet US7988994 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026 Genentech Inc
Esbriet US8753679 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026 Genentech Inc
Esbriet US9561217 Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Jan 25, 2022

(Expired)

 Genentech Inc



Pirfenidone's Family Patents

Family Patents

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Pirfenidone Generic API Manufacturers

Several generic applications have been filed for Pirfenidone. The first generic version for Pirfenidone was by Amneal Eu Ltd and was approved on Jan 3, 2022. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on Dec 18, 2024.

Given below is the list of companies who have filed for Pirfenidone generic, along with the locations of their manufacturing plants worldwide.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

tablet Prescription ORAL AB Jan 25, 2022
801MG

tablet Prescription ORAL AB Jan 25, 2022





2. AIZANT

Aizant Drug Research Solutions Private Ltd has filed for 3 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Aizant.

Strength Dosage Form Availability Application Pathway TE code Launch Date
801MG

tablet Prescription ORAL AB Jul 21, 2022
267MG

tablet Prescription ORAL AB Jul 21, 2022
534MG

tablet Prescription ORAL AB Jul 21, 2022


Manufacturing Plant Locations
New

Aizant's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aizant as present at those locations.

Country City Firm Name
India
Hyderabad Aizant Drug Research Solutions Private Ltd.
Hyderabad Aizant Drug Research Solutions Pvt Ltd., Clinical Pharmacology Unit-II





3. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

tablet Prescription ORAL AB May 20, 2022
801MG

tablet Prescription ORAL AB May 20, 2022


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Limited
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd





4. AMNEAL

Amneal Eu Ltd has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

tablet Prescription ORAL AB Mar 25, 2022
801MG

tablet Prescription ORAL AB Mar 25, 2022


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Glasgow Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Bridgewater Amneal Complex Products Research LLC
Piscataway Amneal Pharmaceuticals, LLC
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited





5. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Discontinued ORAL N/A Jun 9, 2023
801MG

tablet Prescription ORAL AB May 31, 2023


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Richmond Hill Apotex Inc.
Winnipeg Apotex Fermentation Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre





6. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Discontinued ORAL N/A Aug 28, 2023
801MG

tablet Discontinued ORAL N/A Aug 23, 2023





7. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

tablet Prescription ORAL AB Sep 21, 2022
801MG

tablet Prescription ORAL AB Sep 21, 2022





8. LAURUS

Laurus Labs Ltd has filed for 3 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Laurus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Prescription ORAL AB Jul 19, 2022
801MG

tablet Prescription ORAL AB Jul 19, 2022
534MG

tablet Prescription ORAL AB Jul 19, 2022


Manufacturing Plant Locations
New

Laurus's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Laurus as present at those locations.

Country City Firm Name
India
Visakhapatnam Laurus Labs Limited
Anakapalli Laurus Labs Limited (Unit-5)
Anakapalli Laurus Labs Limited
Anikapalli District Laurus Labs Limited
Hyderabad Laurus Labs Limited





9. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Pirfenidone. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Prescription ORAL AB Dec 18, 2024





10. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
801MG

tablet Prescription ORAL AB May 18, 2022
267MG

tablet Prescription ORAL AB May 18, 2022


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bangalore Micro Labs Limited
Bengaluru Micro Labs Limited
Verna Micro Labs Limited





11. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
801MG

tablet Prescription ORAL AB May 24, 2022
267MG

tablet Prescription ORAL AB May 24, 2022


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Isnapur MSN Laboratories Private Limited, Unit-II
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Limited, R&D Center
Sangareddy MSN Pharmachem Private Limited
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Kamareddy MSN Life Sciences Private Limited
Sangareddy MSN Laboratories Private Ltd.
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited
United States
Piscataway MSN PHARMACEUTICALS INC





12. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Prescription ORAL AB Jun 13, 2022
801MG

tablet Prescription ORAL AB Apr 28, 2022


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





13. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
267MG

capsule Prescription ORAL AB Aug 1, 2022
801MG

tablet Prescription ORAL AB Aug 1, 2022





14. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Pirfenidone. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
801MG

tablet Prescription ORAL AB Jan 25, 2022
267MG

tablet Prescription ORAL AB Jan 25, 2022