Data / Drug companies / Bosentan
Bosentan: 7 companies and 14 products in the FDA NDC directory
Bosentan is listed in the FDA National Drug Code Directory by 7 companies, with 14 products in commercial distribution. 11 of the products (78.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, for suspension; tablet, and the newest product started marketing on February 17, 2026.
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- Companies listing it
- 7
- Products
- 14
- Generic (ANDA) products
- 11 (78.6%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Tracleer
- openFDA record search
- api.fda.gov
Companies that list bosentan
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Actelion Pharmaceuticals US, Inc. | 3 | tablet, film coated; tablet, for suspension | New drug applications (NDA) | July 29, 2021 |
| Zydus Lifesciences Limited | 3 | tablet; tablet, for suspension | Generic drugs (ANDA) | February 17, 2026 |
| Actavis Pharma, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | June 19, 2019 |
| Sun Pharmaceutical Industries, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | April 26, 2019 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet, coated | Generic drugs (ANDA) | May 1, 2019 |
| Lupin Pharmaceuticals, Inc. | 1 | tablet, for suspension | Generic drugs (ANDA) | August 18, 2025 |
| Zydus Pharmaceuticals USA Inc. | 1 | tablet, for suspension | Generic drugs (ANDA) | February 17, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 6 | 42.9% |
| Tablet, for suspension | 4 | 28.6% |
| Tablet | 2 | 14.3% |
| Tablet, coated | 2 | 14.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 11 | 78.6% |
| New drug applications (NDA) | 3 | 21.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Endothelin Receptor Antagonist | 14 |
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.