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Generic competition · all medicines · read 12 November 2026

Is there a generic of Bumetanide, and who makes it?

Bumetanide appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 11.7 and 12.2 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Bumetanide3 dosage-form groups in the Orange Book
19generic makers listed
  1. Bumetanide appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 19 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came between 11.7 and 12.2 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Oral

Four or more generic makers listed

Brand listed as marketed: Bumex. 12 generic makers with 36 generic products listed as marketed; the first generic approval is dated 24 April 1995.

19801985199019952000200520102015202020252030012brand 1983Heritage Pharma Labs Inc, first approval 24 April 1995Sandoz Inc, first approval 21 November 1996Amneal Pharmaceuticals Co Gmbh, first approval 18 October 2017Upsher Smith Laboratories Llc, first approval 23 January 2018Zydus Pharmaceuticals Usa Inc, first approval 30 April 2018Rising Pharma Holdings Inc, first approval 12 December 2019Taro Pharmaceutical Industries Ltd, first approval 24 July 2023Appco Pharma Llc, first approval 18 September 2024Rubicon Research Ltd, first approval 27 December 2024Mankind Pharma Ltd, first approval 3 April 2025Jubilant Generics Ltd, first approval 5 August 2025Msn Laboratories Private Ltd, first approval 5 February 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Heritage Pharma Labs Inc24 April 19953
Sandoz Inc21 November 19963
Amneal Pharmaceuticals Co Gmbh18 October 20173
Upsher Smith Laboratories Llc23 January 20183
Zydus Pharmaceuticals Usa Inc30 April 20183
Rising Pharma Holdings Inc12 December 20193
Taro Pharmaceutical Industries Ltd24 July 20233
Appco Pharma Llc18 September 20243
Rubicon Research Ltd27 December 20243
Mankind Pharma Ltd3 April 20253
Jubilant Generics Ltd5 August 20253
Msn Laboratories Private Ltd5 February 20263

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Injectable, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 8 generic makers with 8 generic products listed as marketed; the first generic approval is dated 31 October 1994.

1980198519901995200020052010201520202025203008brand 1983Sagent Pharmaceuticals, first approval 27 January 1995West-Ward Pharmaceuticals International Ltd, first approval 30 April 2008Gland Pharma Ltd, first approval 26 May 2022Msn Laboratories Private Ltd, first approval 4 August 2022Lupin Ltd, first approval 17 September 2024Qilu Pharmaceutical Hainan Co Ltd, first approval 19 September 2024Aspiro Pharma Ltd, first approval 27 February 2025Adaptis Pharma Private Ltd, first approval 26 February 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sagent Pharmaceuticals27 January 19951
West-Ward Pharmaceuticals International Ltd30 April 20081
Gland Pharma Ltd26 May 20221
Msn Laboratories Private Ltd4 August 20221
Lupin Ltd17 September 20241
Qilu Pharmaceutical Hainan Co Ltd19 September 20241
Aspiro Pharma Ltd27 February 20251
Adaptis Pharma Private Ltd26 February 20261

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Spray, Nasal

Brand listed, no generic listed as marketed

Brand listed as marketed: Enbumyst. No generic is listed as marketed.

20202025203020352040204501brand 2025data datePatent 12329731 listed to expire 4 December 2040Patent 11260038 listed to expire 4 December 2040Patent 11123319 listed to expire 4 December 2040Patent 12558330 listed to expire 14 May 2045
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 4 December 2040Patent 12329731 drug product
  • 4 December 2040Patent 11260038
  • 4 December 2040Patent 11123319 drug product
  • 14 May 2045Patent 12558330 drug product

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.