Data / Drug companies / Pirfenidone
Pirfenidone: 26 companies and 62 products in the FDA NDC directory
Pirfenidone is listed in the FDA National Drug Code Directory by 26 companies, with 62 products in commercial distribution. 58 of the products (93.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, coated; capsule, and the newest product started marketing on November 2, 2026.
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- Companies listing it
- 26
- Products
- 62
- Generic (ANDA) products
- 58 (93.5%)
- Application numbers
- 18
- Routes
- Oral
- Brand names
- Esbriet
- openFDA record search
- api.fda.gov
Companies that list pirfenidone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Laurus Labs Limited | 4 | tablet, film coated; capsule | Generic drugs (ANDA) | July 19, 2022 |
| Amneal Pharmaceuticals NY LLC | 3 | tablet, film coated; capsule | Generic drugs (ANDA) | March 29, 2022 |
| Amneal Pharmaceuticals NY LLC | 3 | tablet, film coated; capsule | Generic drugs (ANDA) | February 28, 2023 |
| Aurobindo Pharma Limited | 3 | tablet; capsule | Generic drugs (ANDA) | April 20, 2026 |
| AvKARE | 3 | tablet, film coated; capsule | Generic drugs (ANDA) | October 18, 2023 |
| Cipla USA Inc. | 3 | tablet, coated; capsule | Generic drugs (ANDA) | August 2, 2022 |
| Exelan Pharmaceuticals Inc. | 3 | tablet, coated; capsule | Generic drugs (ANDA) | August 2, 2022 |
| Sandoz Inc | 3 | tablet, film coated; capsule | Generic drugs (ANDA) | January 9, 2023 |
| ScieGen Pharmaceuticals, Inc. | 3 | tablet; capsule | Generic drugs (ANDA) | August 1, 2022 |
| Accord Healthcare Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | May 27, 2022 |
| Alembic Pharmaceuticals Inc. | 2 | tablet, coated | Generic drugs (ANDA) | June 10, 2022 |
| Alembic Pharmaceuticals Limited | 2 | tablet, coated | Generic drugs (ANDA) | June 10, 2022 |
| Ani Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | July 19, 2022 |
| Apotex Corp. | 2 | tablet | Generic drugs (ANDA) | April 9, 2024 |
| Bryant Ranch Prepack | 2 | tablet, coated | Generic drugs (ANDA) | June 10, 2022 |
| Bryant Ranch Prepack | 2 | tablet, coated | Generic drugs (ANDA) | June 10, 2022 |
| Camber Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | September 21, 2022 |
| CivicaScript LLC | 2 | tablet, film coated | Generic drugs (ANDA) | November 2, 2026 |
| Genentech, Inc. | 2 | tablet, coated | New drug applications (NDA) | January 11, 2017 |
| Golden State Medical Supply, Inc. | 2 | tablet | Generic drugs (ANDA) | May 31, 2023 |
| Legacy Pharma USA Inc. | 2 | tablet, coated | New drug applications (NDA) | May 31, 2025 |
| Major Pharmaceuticals | 2 | tablet, film coated | Generic drugs (ANDA) | May 24, 2022 |
| Micro Labs Limited | 2 | tablet, film coated | Generic drugs (ANDA) | December 1, 2022 |
| NorthStar RxLLC | 2 | tablet, film coated | Generic drugs (ANDA) | May 24, 2022 |
| Novadoz Pharmaceuticals LLC | 2 | tablet, film coated | Generic drugs (ANDA) | September 7, 2022 |
| Teva Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | May 11, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 29 | 46.8% |
| Tablet, coated | 16 | 25.8% |
| Capsule | 9 | 14.5% |
| Tablet | 8 | 12.9% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 58 | 93.5% |
| New drug applications (NDA) | 4 | 6.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Pyridone | 62 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.