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OmniRx › Tools › Generic competition check › Sirolimus

Generic competition · all medicines · read 12 November 2026

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

Sirolimus appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them. 2 groups have 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 13.4 and 19.4 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.
Sirolimus4 dosage-form groups in the Orange Book
10generic makers listed
  1. Sirolimus appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 10 generic makers listed as marketed across them.
  2. 2 groups have 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 13.4 and 19.4 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: Rapamune. 4 generic makers with 11 generic products listed as marketed; the first generic approval is dated 8 January 2014.

200020052010201520202025203004brand 2000Zydus Pharmaceuticals Usa Inc, first approval 8 January 2014Dr Reddys Laboratories Ltd, first approval 27 October 2014Glenmark Pharmaceuticals Ltd, first approval 16 October 2020Alkem Laboratories Ltd, first approval 12 March 2021data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Zydus Pharmaceuticals Usa Inc8 January 20143
Dr Reddys Laboratories Ltd27 October 20142
Glenmark Pharmaceuticals Ltd16 October 20203
Alkem Laboratories Ltd12 March 20213

Patents and exclusivities still listed

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

Solution, Oral

Four or more generic makers listed

Brand listed as marketed: Rapamune. 6 generic makers with 6 generic products listed as marketed; the first generic approval is dated 28 January 2019.

1995200020052010201520202025203006brand 1999Novitium Pharma Llc, first approval 28 January 2019Amneal Pharmaceuticals Llc, first approval 18 October 2019Apotex Inc, first approval 22 October 2019Msn Laboratories Private Ltd, first approval 19 January 2023Hetero Labs Ltd Unit V, first approval 16 September 2024Rising Pharma Holdings Inc, first approval 15 July 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Novitium Pharma Llc28 January 20191
Amneal Pharmaceuticals Llc18 October 20191
Apotex Inc22 October 20191
Msn Laboratories Private Ltd19 January 20231
Hetero Labs Ltd Unit V16 September 20241
Rising Pharma Holdings Inc15 July 20251

Patents and exclusivities still listed

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

Gel, Topical

Brand listed, no generic listed as marketed

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

20202025203020352040204501brand 2022data datePatent 12740970 listed to expire 11 April 2045Exclusivity ODE-391 to 22 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 March 2029Exclusivity ODE-391 Hyftor
  • 11 April 2045Patent 12740970 drug product

Powder, Intravenous

Brand listed, no generic listed as marketed

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

2020202520302035204001brand 2021data datePatent 8911786 listed to expire 14 February 2029Patent 10206887 listed to expire 15 April 2030Patent 12061183 listed to expire 5 March 2036Patent 10705070 listed to expire 5 March 2036Patent 12133844 listed to expire 29 June 2036Patent 10973806 listed to expire 29 June 2036Patent 11497737 listed to expire 28 October 2040Exclusivity ODE-386 to 22 November 2028
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 November 2028Exclusivity ODE-386 Fyarro
  • 14 February 2029Patent 8911786 drug product
  • 15 April 2030Patent 10206887 drug product
  • 5 March 2036Patent 12061183 drug product
  • 5 March 2036Patent 10705070 drug product
  • 29 June 2036Patent 12133844
  • 29 June 2036Patent 10973806
  • 28 October 2040Patent 11497737 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.