Pirfenidone Patent Expiration
Pirfenidone is used for treating idiopathic pulmonary fibrosis. It was first introduced by Genentech Inc
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 | 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 | 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 | US7767225 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients | Sep 22, 2026 | Genentech Inc |
| Esbriet | US7767700 | Method of providing pirfenidone therapy to a patient | Dec 18, 2027 | 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 | US7988994 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients | Sep 22, 2026 | 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 | US8383150 | Granulate formulation of pirfenidone and pharmaceutically acceptable excipients | May 10, 2028 | Genentech Inc |
| Esbriet | US8420674 | Method of providing pirfenidone therapy to a patient | Dec 18, 2027 | 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 | US8648098 | Pirfenidone therapy and inducers of cytochrome P450 | Jan 08, 2030 | Genentech Inc |
| Esbriet | US8753679 | Capsule formulation of pirfenidone and pharmaceutically acceptable excipients | Sep 22, 2026 | Genentech Inc |
| Esbriet | US8754109 | Pirfenidone therapy and inducers of cytochrome P450 | Jan 08, 2030 | Genentech Inc |
| Esbriet | US8778947 | Methods of administering pirfenidone therapy | Aug 30, 2033 | Genentech Inc |
| Esbriet | US9561217 | Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone |
Jan 25, 2022
(Expired) | Genentech Inc |
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Pirfenidone Generics
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 Chartwell Rx Sciences Llc and was approved on Aug 28, 2023.
Given below is the list of companies who have filed for Pirfenidone generic.
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. 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 |
3. 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 |
|---|---|---|---|---|---|
| 267MG | tablet | Prescription | ORAL | AB | Jan 25, 2022 |
| 801MG | tablet | Prescription | ORAL | AB | Jan 25, 2022 |
4. 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 |
5. 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 |
6. 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 |
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. 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 | tablet | Prescription | ORAL | AB | Aug 1, 2022 |
| 801MG | tablet | Prescription | ORAL | AB | Aug 1, 2022 |
9. 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 |
|---|---|---|---|---|---|
| 801MG | tablet | Prescription | ORAL | AB | Jul 19, 2022 |
| 267MG | capsule | Prescription | ORAL | AB | Jul 19, 2022 |
| 534MG | tablet | Prescription | ORAL | AB | Jul 19, 2022 |
10. 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 |
11. 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 |
12. 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 |
|---|---|---|---|---|---|
| 267MG | tablet | Prescription | ORAL | AB | Jul 21, 2022 |
| 801MG | tablet | Prescription | ORAL | AB | Jul 21, 2022 |
| 534MG | tablet | Prescription | ORAL | AB | Jul 21, 2022 |
13. 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 |