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OmniRx › Tools › Generic competition check › Micafungin Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Micafungin Sodium, and who makes it?

Micafungin Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 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 14.2 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.
Micafungin Sodium3 dosage-form groups in the Orange Book
11generic makers listed
  1. Micafungin Sodium appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 11 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 14.2 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.

Injectable, Intravenous

Four or more generic makers listed

Every brand product here is listed as discontinued. 11 generic makers with 22 generic products listed as marketed; the first generic approval is dated 17 May 2019.

200520102015202020252030011brand 2005Fresenius Kabi Usa Llc, first approval 17 May 2019Xellia Pharmaceuticals Aps, first approval 2 June 2021Hikma Pharmaceuticals International Ltd, first approval 9 July 2021Jiangsu Hansoh Pharmaceutical Group Co Ltd, first approval 9 July 2021Meitheal Pharmaceuticals Inc, first approval 28 September 2022Zydus Pharmaceuticals Usa Inc, first approval 24 October 2022Biocon Pharma Ltd, first approval 29 May 2024Qilu Pharmaceutical Hainan Co Ltd, first approval 3 April 2025Hisun Pharmaceutical (Hangzhou) Co Ltd, first approval 21 January 2026Yichang Humanwell Pharmaceutical Co Ltd, first approval 24 February 2026Aspiro Pharma Ltd, first approval 17 March 2026data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Fresenius Kabi Usa Llc17 May 20192
Xellia Pharmaceuticals Aps2 June 20212
Hikma Pharmaceuticals International Ltd9 July 20212
Jiangsu Hansoh Pharmaceutical Group Co Ltd9 July 20212
Meitheal Pharmaceuticals Inc28 September 20222
Zydus Pharmaceuticals Usa Inc24 October 20222
Biocon Pharma Ltd29 May 20242
Qilu Pharmaceutical Hainan Co Ltd3 April 20252
Hisun Pharmaceutical (Hangzhou) Co Ltd21 January 20262
Yichang Humanwell Pharmaceutical Co Ltd24 February 20262
Aspiro Pharma Ltd17 March 20262

Patents and exclusivities still listed

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

Powder, Intravenous

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

20202025203001brand 2021data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

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

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Micafungin In Sodium Chloride 0.9%. No generic is listed as marketed.

2020202520302035204001brand 2023data datePatent 12403173 listed to expire 15 December 2037
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 15 December 2037Patent 12403173 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.