Drug
Who makes buprenorphine?
22 companies list buprenorphine as a human prescription drug, including under the names BRIXADI, Butrans, SUBLOCADE. Forms: injection; patch; patch, extended release; solution; tablet. Routes: subcutaneous, sublingual, transdermal.
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 buprenorphine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Braeburn Inc. | injection | NDANDA210136 | 7 | 0 |
| Rhodes Pharmaceuticals LLC | patch; tablet | ANDA, NDA AUTHORIZED GENERICANDA207276, NDA021306 | 7 | 0 |
| Bryant Ranch PrepackUnited States | tablet | ANDAANDA201760, ANDA207276 | 6 | 1 |
| Teva Pharmaceutical Industries Ltd.Canada | patch, extended release | ANDAANDA204937 | 5 | 6 |
| Aveva Drug Delivery Systems Inc.United States | patch, extended release | ANDAANDA210272 | 5 | 1 |
| Knoa Pharma LLCUnited States | patch, extended release | NDANDA021306 | 5 | 1 |
| Amneal Pharmaceuticals NY LLC | patch, extended release | ANDAANDA211586 | 5 | 0 |
| Ingenus Pharmaceuticals, LLC | patch, extended release | ANDAANDA210272 | 5 | 0 |
| CLINICAL SOLUTIONS WHOLESALE, LLCUnited States | tablet | ANDAANDA201760, ANDA207276 | 4 | 1 |
| Alvogen, Inc. | patch, extended release | ANDAANDA207490 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | tablet | ANDAANDA201760 | 2 | 13 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA207276 | 2 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA078633 | 2 | 4 |
| Indivior Inc.United States | solution | NDANDA209819 | 2 | 2 |
| Actavis LLCUnited States | tablet | ANDAANDA090819 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA207276 | 2 | 1 |
| AvPAK | tablet | ANDAANDA201760 | 2 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA078633 | 2 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA207276 | 1 | 3 |
| LTS Therapy Systems, LLCUnited States | patch, extended release | ANDAANDA207490 | 1 | 3 |
| RedPharm DrugUnited States | tablet | ANDAANDA201760 | 1 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA090819 | 1 | 1 |
Bulk ingredient listings
- Arevipharma GmbHGermany · 1 NDC
- Indivior Inc.United States · 1 NDC
- Janssen Pharmaceuticals Sciences Unlimited Company · 1 NDC
- Janssen Pharmaceuticals, Inc. · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Macfarlan Smith LimitedUnited Kingdom · 1 NDC
- Noramco, LLCUnited States · 1 NDC
- PCASFrance · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Siegfried USA, LLCUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- TAPI Czech Industries s.r.o.Czechia · 1 NDC
- Teva Czech Industries s.r.o.Czechia · 1 NDC
- Veranova, L.P.United States · 1 NDC
Orange Book patents
20 unexpired patents list buprenorphine as the active ingredient, expiring between Jan 2027 and Jun 2038. Application holders: BRAEBURN INC, INDIVIOR INC.
Enquiry
Common questions
- Who makes buprenorphine?
- 22 companies list buprenorphine as a human prescription drug in the openFDA NDC Directory, led by Braeburn Inc., Rhodes Pharmaceuticals LLC, Bryant Ranch Prepack, Teva Pharmaceutical Industries Ltd., Aveva Drug Delivery Systems Inc.. 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 BRIXADI?
- 19 companies list buprenorphine under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies buprenorphine active ingredient?
- 14 companies list buprenorphine as a bulk ingredient, including Arevipharma GmbH, Indivior Inc., Janssen Pharmaceuticals Sciences Unlimited Company, Janssen Pharmaceuticals, Inc..