Drug
Who makes bosentan?
6 companies list bosentan as a human prescription drug, including under the names Tracleer. Forms: tablet; tablet, coated; tablet, film coated; tablet, for suspension. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing bosentan
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Zydus Lifesciences LimitedIndia | tablet; tablet, for suspension | ANDAANDA207760, ANDA213981 | 3 | 12 |
| Zydus Pharmaceuticals USA Inc.India | tablet, coated; tablet, for suspension | ANDAANDA207760, ANDA213981 | 3 | 1 |
| Actelion Pharmaceuticals US, Inc. | tablet, film coated; tablet, for suspension | NDANDA021290, NDA209279 | 3 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet, film coated | ANDAANDA209324 | 2 | 13 |
| Actavis LLCUnited States | tablet, film coated | ANDAANDA207110 | 2 | 1 |
| Lupin LimitedIndia | tablet, for suspension | ANDAANDA213154 | 1 | 14 |
Bulk ingredient listings
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- Mylan Pharmaceuticals, Inc. · 1 NDC
- Viyash Life Sciences Private Limited · 1 NDC
Orange Book patents
1 unexpired patent lists bosentan as the active ingredient, expiring between Dec 2027 and Dec 2027. Application holder: ACTELION PHARMACEUTICALS US INC.
Enquiry
Common questions
- Who makes bosentan?
- 6 companies list bosentan as a human prescription drug in the openFDA NDC Directory, led by Zydus Lifesciences Limited, Zydus Pharmaceuticals USA Inc., Actelion Pharmaceuticals US, Inc., Sun Pharmaceutical Industries Limited, Actavis LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Tracleer?
- 5 companies list bosentan under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies bosentan active ingredient?
- 4 companies list bosentan as a bulk ingredient, including CIPLA PHARMACEUTICALS LIMITED, MSN Laboratories Private Limited,, Mylan Pharmaceuticals, Inc., Viyash Life Sciences Private Limited.