FDA Orange Book · active-ingredient family
Bumetanide
Bumetanide is approved as 3 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ENBUMYST · NDA 219500
3
Brand (NDA)
23
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, spray, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENBUMYSTRLD | CORSTASIS THERAP | NDA 219500 | — | Sep 12, 2025 | |
| BUMEXRLD | VALIDUS PHARMS | NDA 018226 | — | Feb 28, 1983 | |
| BUMEXRLD×3 | VALIDUS PHARMS | NDA 018225 | AB | Feb 28, 1983 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUMETANIDE | ANTHEA PHARMA | ANDA 220427 | AP | Feb 26, 2026 | |
| BUMETANIDE×3 | MSN | ANDA 215362 | AB | Feb 05, 2026 | |
| BUMETANIDE×3 | JUBILANT GENERICS | ANDA 212470 | AB | Aug 05, 2025 | |
| BUMETANIDE×3 | MANKIND PHARMA | ANDA 219291 | AB | Apr 03, 2025 | |
| BUMETANIDE | ASPIRO | ANDA 218746 | AP | Feb 27, 2025 | |
| BUMETANIDE×3 | RUBICON RESEARCH | ANDA 213942 | AB | Dec 27, 2024 | |
| BUMETANIDE | QILU PHARM HAINAN | ANDA 219116 | AP | Sep 19, 2024 | |
| BUMETANIDE×3 | APPCO | ANDA 212931 | AB | Sep 18, 2024 | |
| BUMETANIDE | LUPIN | ANDA 217153 | AP | Sep 17, 2024 | |
| BUMETANIDE×3 | TARO | ANDA 213458 | AB | Jul 24, 2023 | |
| BUMETANIDE | MSN | ANDA 215364 | AP | Aug 04, 2022 | |
| BUMETANIDE | GLAND | ANDA 216434 | AP | May 26, 2022 | |
| BUMETANIDE×3 | RISING | ANDA 212019 | AB | Dec 12, 2019 | |
| BUMETANIDE×3 | ZYDUS PHARMS | ANDA 202900 | AB | Apr 30, 2018 | |
| BUMETANIDE×3 | UPSHER SMITH LABS | ANDA 209916 | AB | Jan 23, 2018 | |
| BUMETANIDE×3 | AMNEAL PHARMS CO | ANDA 209724 | AB | Oct 18, 2017 | |
| BUMETANIDE | WEST-WARD PHARMS INT | ANDA 079196 | AP | Apr 30, 2008 | |
| BUMETANIDE | TEVA PARENTERAL | ANDA 074613 | — | Nov 18, 1997 | |
| BUMETANIDE | HOSPIRA | ANDA 074160 | — | Oct 30, 1997 | |
| BUMETANIDE×3 | SANDOZ | ANDA 074700 | AB | Nov 21, 1996 | |
| BUMETANIDE×3 | HERITAGE PHARMA | ANDA 074225 | AB | Apr 24, 1995 | |
| BUMETANIDE | SAGENT | ANDA 074441 | AP | Jan 27, 1995 | |
| BUMETANIDE | HOSPIRA | ANDA 074332 | — | Oct 31, 1994 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12329731 | Dec 04, 2040 | in 14 yr 8 mo | ProductU-4279 |
| 11260038 | Dec 04, 2040 | in 14 yr 8 mo | U-4279 |
| 11123319 | Dec 04, 2040 | in 14 yr 8 mo | Product |
| 12558330 | May 14, 2045 | in 19 yr 2 mo | ProductU-4279 |
Bumetanide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
