Last Updated: May 3, 2026

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 Ltd, 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 Ltd 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 018225-001 Feb 28, 1983 ⤷  Start Trial ⤷  Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-002 Feb 28, 1983 ⤷  Start Trial ⤷  Start Trial
Validus Pharms BUMEX bumetanide INJECTABLE;INJECTION 018226-001 Feb 28, 1983 ⤷  Start Trial ⤷  Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-002 Feb 28, 1983 ⤷  Start Trial ⤷  Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-001 Feb 28, 1983 ⤷  Start Trial ⤷  Start Trial
Validus Pharms BUMEX bumetanide TABLET;ORAL 018225-003 Jun 14, 1985 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for bumetanide

Country Patent Number Title Estimated Expiration
Australia 2020397176 ⤷  Start Trial
Canada 3160278 PROCEDES ET COMPOSITIONS POUR TRAITER UN OEDEME REFRACTAIRE A DES DIURETIQUES ORAUX (METHODS AND COMPOSITIONS FOR TREATING EDEMA REFRACTORY TO ORAL DIURETICS) ⤷  Start Trial
European Patent Office 4069222 ⤷  Start Trial
South Korea 20220113436 경구 이뇨제에 불응성인 부종 치료 방법 및 조성물 ⤷  Start Trial
South Korea 20220113436 ⤷  Start Trial
Brazil 112022010879 MÉTODOS E COMPOSIÇÕES PARA TRATAMENTO DE EDEMA REFRATÁRIO A DIURÉTICOS ORAIS ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

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