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OmniRx › Tools › Generic competition check › Amikacin Sulfate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Amikacin Sulfate, and who makes it?

Amikacin Sulfate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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. 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.
Amikacin Sulfate2 dosage-form groups in the Orange Book
6generic makers listed
  1. Amikacin Sulfate appears in 2 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 6 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. 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, Injection

Four or more generic makers listed

Every brand product here is listed as discontinued. 6 generic makers with 7 generic products listed as marketed; the first generic approval is dated 20 September 1984.

198519901995200020052010201520202025203006brand 1987Meitheal Pharmaceuticals Inc, first approval 28 September 1993Hikma Pharmaceuticals Usa Inc, first approval 11 April 1994Avet Lifesciences Ltd, first approval 12 December 2013Fresenius Kabi Usa Llc, first approval 9 December 2015Sagent Pharmaceuticals Inc, first approval 12 May 2016Qilu Pharmaceutical Co Ltd, first approval 19 March 2024data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Meitheal Pharmaceuticals Inc28 September 19931
Hikma Pharmaceuticals Usa Inc11 April 19942
Avet Lifesciences Ltd12 December 20131
Fresenius Kabi Usa Llc9 December 20151
Sagent Pharmaceuticals Inc12 May 20161
Qilu Pharmaceutical Co Ltd19 March 20241

Patents and exclusivities still listed

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

Suspension, Liposomal, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Arikayce Kit. No generic is listed as marketed.

2015202020252030203501brand 2018data datePatent 8679532 listed to expire 5 December 2026Patent 8632804 listed to expire 5 December 2026Patent 8642075 listed to expire 5 December 2026Patent 8226975 listed to expire 15 August 2028Patent 9566234 listed to expire 18 January 2034Patent 10251900 listed to expire 15 May 2035Patent 12377114 listed to expire 15 May 2035Patent 9895385 listed to expire 15 May 2035Patent 12016873 listed to expire 15 May 2035Patent 10751355 listed to expire 15 May 2035Patent 11446318 listed to expire 15 May 2035Patent 12168022 listed to expire 15 May 2035Patent 12168021 listed to expire 15 May 2035Patent 12616708 listed to expire 15 May 2035Exclusivity GAIN to 28 September 2030
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 28 September 2030Exclusivity GAIN Arikayce Kit
  • 5 December 2026Patent 8679532
  • 5 December 2026Patent 8632804
  • 5 December 2026Patent 8642075 drug product
  • 15 August 2028Patent 8226975 drug product
  • 18 January 2034Patent 9566234 drug product
  • 15 May 2035Patent 10251900
  • 15 May 2035Patent 12377114
  • 15 May 2035Patent 9895385

6 more patents are listed.

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.