bumetanide - Profile
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What are the generic sources for bumetanide and what is the scope of freedom to operate?
Bumetanide
is the generic ingredient in three branded drugs marketed by Anthea Pharma, Aspiro, Gland, Hospira, Lupin, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Validus Pharms, Corstasis Therap, Amneal Pharms Co, Appco, Heritage Pharma, Jubilant Generics, Mankind Pharma, Rising, Rubicon Research, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in twenty-six NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bumetanide has nine patent family members in nine countries.
Summary for bumetanide
| International Patents: | 9 |
| US Patents: | 4 |
| Tradenames: | 3 |
| Applicants: | 23 |
| NDAs: | 26 |
US Patents and Regulatory Information for bumetanide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anthea Pharma | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 220427-001 | Feb 26, 2026 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aspiro | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 218746-001 | Feb 27, 2025 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Gland | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 216434-001 | May 26, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 074160-001 | Oct 30, 1997 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hospira | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 074332-001 | Oct 31, 1994 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lupin | BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 217153-001 | Sep 17, 2024 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for bumetanide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-002 | Feb 28, 1983 | 3,806,534 | ⤷ Start Trial |
| Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-001 | Feb 28, 1983 | 3,806,534 | ⤷ Start Trial |
| Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-003 | Jun 14, 1985 | 3,634,583 | ⤷ Start Trial |
| Validus Pharms | BUMEX | bumetanide | INJECTABLE;INJECTION | 018226-001 | Feb 28, 1983 | 3,634,583 | ⤷ Start Trial |
| Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-001 | Feb 28, 1983 | 3,634,583 | ⤷ Start Trial |
| Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-002 | Feb 28, 1983 | 3,634,583 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for bumetanide
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3160278 | ⤷ Start Trial | |
| South Korea | 20220113436 | ⤷ Start Trial | |
| China | 115023223 | ⤷ Start Trial | |
| Australia | 2020397176 | ⤷ Start Trial | |
| China | 115023223 | 用于治疗口服利尿剂难治性水肿的方法和组合物 (Methods and compositions for treating edema refractory to oral diuretics) | ⤷ Start Trial |
| World Intellectual Property Organization (WIPO) | 2021113775 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
