Buprenorphine
As of the edition of 20 October 2026, Buprenorphine is a small molecule: marketed, first approved in 1979 (CH); acts on OPRK1 and OPRM1; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Buprenex
- First approved
- 23 October 1979 (CH)
- Approvals on record
- 65 in 8 regions
- Holder of the most recent approval
- Neuraxpharm Pharmaceuticals; 17 holders in all
- Withdrawn from market
- 19 June 2025 (in some regions)
- Registered trials
- 360, 51 stopped early
- Disease areas
- Mental health; Chemically induced; Infections; Immune system; Urinary and reproductive; Bones, joints and muscles
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Indivior.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Buprenorphine.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 48 | 30 | 7 | 6 |
| Phase 1 | 55 | 43 | 3 | 6 |
| Phase 2 | 99 | 74 | 7 | 11 |
| Phase 3 | 85 | 55 | 8 | 18 |
| Phase 4 | 73 | 43 | 16 | 10 |
| All trials | 360 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Purdue Pharma | Applicant and Lead sponsor of trials | 1997 to now |
| Reckitt Benckiser | Later holder | 2002 to now |
| Indivior | Acquired holder and Lead sponsor of trials | 2005 to now |
| Mundipharma | Applicant | 2011 to now |
| Collegium Pharmaceutical | Acquired holder and Lead sponsor of trials | 2013 to now |
| Braeburn Pharmaceuticals | Later holder and Lead sponsor of trials | 2015 to now |
| Endo | Later holder | 2015 to now |
| Accord Healthcare | Applicant | 2017 to now |
| Camurus | Later holder | 2018 to now |
| ReacX Pharmaceuticals | Acquired holder | 2024 to now |
| Neuraxpharm Pharmaceuticals | Later holder | 2024 to now |
| Knoa Pharma | Acquired holder | 2026 to now |