Applicant, as named in the Orange Book
Indivior
Next listed expiry: Suboxone on 26 Mar 2030. 3 products with live protection, 0 without.
Products with listed protection
| Drug | Ingredient | NDA | Earliest generic entry | Basis |
|---|
| Suboxone · 4 strengths buprenorphine hydrochloride; naloxone hydrochloride | buprenorphine hydrochloride; naloxone hydrochloride | 022410 | 26 Mar 2030 | patent |
| Sublocade · 2 strengths buprenorphine | buprenorphine | 209819 | 6 Nov 2035 | patent, carve-out possible |
| Opvee nalmefene hydrochloride | nalmefene hydrochloride | 217470 | 4 Aug 2042 | patent, carve-out possible |
Recent events
- 25 Oct 2026Subutex · Generic approved 10 Dec 2025
- 25 Oct 2026Subutex · Generic approved 18 Dec 2025
- 25 Oct 2026Buprenex · Generic approved 15 Oct 2026
- 25 Oct 2026Suboxone · Generic approved 21 Jan 2026