FDA Orange Book · active-ingredient family
Buprenorphine
Buprenorphine is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BRIXADI · NDA 210136
3
Brand (NDA)
5
Generics (ANDA)
21
Listed patents
9
Exclusivity periods
Brand (NDA) products · film, extended release, solution, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRIXADIRLD×7 | BRAEBURN | NDA 210136 | — | May 23, 2023 | |
| SUBLOCADERLD×2 | INDIVIOR | NDA 209819 | — | Nov 30, 2017 | |
| BUTRANSRLD×5 | KNOA PHARMA | NDA 021306 | AB | Jun 30, 2010 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUPRENORPHINE×5 | STRIDES PHARMA INTL | ANDA 207490 | AB | May 17, 2022 | |
| BUPRENORPHINE×5 | DIFGEN PHARMS | ANDA 210272 | AB | Sep 23, 2021 | |
| BUPRENORPHINE×5 | MYLAN TECH VIATRIS | ANDA 210162 | — | May 03, 2021 | |
| BUPRENORPHINE×5 | AMNEAL | ANDA 211586 | AB | Apr 14, 2020 | |
| BUPRENORPHINE×5 | WATSON LABS TEVA | ANDA 204937 | AB | Nov 20, 2018 |
Marketing exclusivity (9)
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- NPNew product exclusivity (3 years)
May 23, 2026
27 d ago
- M-314New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
- M-314New use / labeling-change exclusivity (3 years)
Feb 21, 2028
in 1 yr 8 mo
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8236755 | Jul 31, 2026 | in 1 mo | ProductU-3620 |
| 8236292 | Jan 10, 2027 | in 7 mo | ProductU-3619 |
| 9827241 | Jun 06, 2031 | in 5 yr | ProductU-2206 |
| 9782402 | Jun 06, 2031 | in 5 yr | ProductU-2180 |
| 9272044 | Jun 06, 2031 | in 5 yr | U-2176 |
| 10198218 | Jun 06, 2031 | in 5 yr | U-2489 |
| 9498432 | Jun 06, 2031 | in 5 yr | ProductU-2179 |
| 10592168 | Jun 06, 2031 | in 5 yr | U-2489 |
| 10558394 | Jun 25, 2031 | in 5 yr 1 mo | Product |
| 8975270 | Sep 05, 2031 | in 5 yr 3 mo | ProductU-2206 |
| 8921387 | Jan 06, 2032 | in 5 yr 8 mo | ProductU-2174 |
| 12318379 | Jul 26, 2032 | in 6 yr 2 mo | ProductU-4100 |
| 12161640 | Jul 26, 2032 | in 6 yr 2 mo | ProductU-4100 |
| 11110084 | Jul 26, 2032 | in 6 yr 2 mo | ProductU-3616 |
| 10912772 | Jul 26, 2032 | in 6 yr 2 mo | U-3617 |
| 9937164 | Jul 26, 2032 | in 6 yr 2 mo | ProductU-3618 |
| 11135215 | Jul 26, 2032 | in 6 yr 2 mo | Product |
| 11000520 | Nov 06, 2035 | in 9 yr 6 mo | U-3111 |
| 11839611 | Nov 06, 2035 | in 9 yr 6 mo | U-3111 |
| 12622904 | Nov 06, 2035 | in 9 yr 6 mo | U-4528 |
| 10646484 | Jun 22, 2038 | in 12 yr 2 mo | U-2489 |
Buprenorphine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
