FDA Orange Book · active-ingredient family
Buprenorphine hydrochloride
Buprenorphine hydrochloride is approved as 4 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROBUPHINE · NDA 204442
4
Brand (NDA)
15
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, implant, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROBUPHINERLD | REACX PHARMS | NDA 204442 | — | May 26, 2016 | |
| BELBUCARLD×7 | BDSI | NDA 207932 | — | Oct 23, 2015 | |
| SUBUTEXRLD×2 | INDIVIOR | NDA 020732 | — | Oct 08, 2002 | |
| BUPRENEXRLD | INDIVIOR | NDA 018401 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUPRENORPHINE HYDROCHLORIDE×2 | ASCENT PHARMS INC | ANDA 219401 | AB | Dec 18, 2025 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | SPECGX LLC | ANDA 218473 | AB | Dec 10, 2025 | |
| BUPRENORPHINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 219302 | AP | Jan 30, 2025 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | RHODES PHARMS | ANDA 207276 | AB | Mar 27, 2017 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | SUN PHARM | ANDA 201760 | AB | Jan 29, 2016 | |
| BUPRENORPHINE HYDROCHLORIDE | PH HEALTH | ANDA 206586 | AP | Jul 28, 2015 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | RUBICON RESEARCH | ANDA 090279 | AB | Jun 10, 2015 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | PHARMOBEDIENT | ANDA 201066 | — | Mar 06, 2015 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | ACTAVIS ELIZABETH | ANDA 090819 | AB | Feb 19, 2015 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | ETHYPHARM | ANDA 090622 | AB | Sep 24, 2010 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | BARR | ANDA 090360 | — | May 07, 2010 | |
| BUPRENORPHINE HYDROCHLORIDE×2 | HIKMA | ANDA 078633 | AB | Oct 08, 2009 | |
| BUPRENORPHINE HYDROCHLORIDE | AM REGENT | ANDA 078331 | — | Mar 27, 2007 | |
| BUPRENORPHINE HYDROCHLORIDE | HIKMA | ANDA 076931 | AP | Mar 02, 2005 | |
| BUPRENORPHINE HYDROCHLORIDE | HOSPIRA | ANDA 074137 | AP | Jun 03, 1996 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9655843 | Jul 23, 2027 | in 1 yr 1 mo | ProductU-1556 |
| 8147866 | Jul 23, 2027 | in 1 yr 1 mo | ProductU-1769 |
| 9901539 | Dec 21, 2032 | in 6 yr 7 mo | U-1556 |
Buprenorphine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
