Data / Drug companies / Buprenorphine
Buprenorphine: 24 companies and 73 products in the FDA NDC directory
Buprenorphine is listed in the FDA National Drug Code Directory by 24 companies, with 73 products in commercial distribution. 54 of the products (74.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are patch, extended release; tablet; injection, and the newest product started marketing on June 30, 2026.
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- Companies listing it
- 24
- Products
- 73
- Generic (ANDA) products
- 54 (74.0%)
- Application numbers
- 11
- Controlled substance schedule
- Schedule III
- Routes
- Transdermal, Sublingual, Subcutaneous
- Brand names
- Brixadi, Butrans, Sublocade
- openFDA record search
- api.fda.gov
Companies that list buprenorphine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Braeburn Inc. | 7 | injection | New drug applications (NDA) | June 6, 2023 |
| Rhodes Pharmaceuticals LLC | 7 | patch; tablet | Authorized generics (NDA) | October 25, 2017 |
| Amneal Pharmaceuticals NY LLC | 5 | patch, extended release | Generic drugs (ANDA) | April 20, 2020 |
| Aveva Drug Delivery Systems Inc. | 5 | patch, extended release | Generic drugs (ANDA) | November 1, 2023 |
| Ingenus Pharmaceuticals, LLC | 5 | patch, extended release | Generic drugs (ANDA) | November 1, 2023 |
| Knoa Pharma LLC | 5 | patch, extended release | New drug applications (NDA) | February 14, 2011 |
| Teva Pharmaceuticals USA, Inc. | 5 | patch, extended release | Generic drugs (ANDA) | December 27, 2021 |
| Alvogen Inc. | 4 | patch, extended release | Generic drugs (ANDA) | May 17, 2022 |
| Clinical Solutions Wholesale, LLC | 4 | tablet | Generic drugs (ANDA) | October 25, 2017 |
| Bryant Ranch Prepack | 3 | tablet | Generic drugs (ANDA) | October 25, 2017 |
| Actavis Pharma, Inc. | 2 | tablet | Generic drugs (ANDA) | February 19, 2015 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | February 6, 2020 |
| AvPAK | 2 | tablet | Generic drugs (ANDA) | March 19, 2024 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | October 25, 2017 |
| Hikma Pharmaceuticals USA Inc. | 2 | tablet | Generic drugs (ANDA) | October 8, 2009 |
| Indivior Inc. | 2 | solution | New drug applications (NDA) | February 26, 2018 |
| Major Pharmaceuticals | 2 | tablet | Generic drugs (ANDA) | October 8, 2009 |
| Sun Pharmaceutical Industries, Inc. | 2 | tablet | Generic drugs (ANDA) | February 17, 2016 |
| Unit Dose Solutions, Inc. | 2 | tablet | Generic drugs (ANDA) | June 30, 2026 |
| A-S Medication Solutions | 1 | tablet | Generic drugs (ANDA) | October 25, 2017 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | October 25, 2017 |
| LTS Therapy Systems, LLC | 1 | patch, extended release | Generic drugs (ANDA) | May 17, 2022 |
| Redpharm Drug | 1 | tablet | Generic drugs (ANDA) | February 17, 2016 |
| Remedyrepack Inc. | 1 | tablet | Generic drugs (ANDA) | October 19, 2018 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Patch, extended release | 30 | 41.1% |
| Tablet | 29 | 39.7% |
| Injection | 7 | 9.6% |
| Patch | 5 | 6.8% |
| Solution | 2 | 2.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 54 | 74% |
| New drug applications (NDA) | 14 | 19.2% |
| Authorized generics (NDA) | 5 | 6.8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Partial Opioid Agonist | 73 |
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.