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OmniRx › Tools › Generic competition check › Leuprolide Acetate

Generic competition · all medicines · read 12 November 2026

Is there a generic of Leuprolide Acetate, and who makes it?

Leuprolide Acetate appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 generic makers listed as marketed across them. 4 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 13.3 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.
Leuprolide Acetate6 dosage-form groups in the Orange Book
8generic makers listed
  1. Leuprolide Acetate appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 8 generic makers listed as marketed across them.
  2. 4 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 13.3 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.

Solution, Subcutaneous

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 4 August 1998.

198519901995200020052010201520202025203008brand 1985Sandoz Inc, first approval 4 August 1998Meitheal Pharmaceuticals Inc, first approval 25 October 2000Sun Pharmaceutical Industries Ltd, first approval 9 March 2009Somerset Therapeutics Llc, first approval 13 August 2021Eugia Pharma Specialities Ltd, first approval 6 June 2022Amneal Eu Ltd, first approval 28 October 2022Ubi Pharma Inc, first approval 17 October 2024Zydus Pharmaceuticals Usa Inc, first approval 13 November 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc4 August 19981
Meitheal Pharmaceuticals Inc25 October 20001
Sun Pharmaceutical Industries Ltd9 March 20091
Somerset Therapeutics Llc13 August 20211
Eugia Pharma Specialities Ltd6 June 20221
Amneal Eu Ltd28 October 20221
Ubi Pharma Inc17 October 20241
Zydus Pharmaceuticals Usa Inc13 November 20251

Patents and exclusivities still listed

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

Powder, Intramuscular

Brand listed, no generic listed as marketed

Brand listed as marketed: Lupron Depot-Ped Kit. No generic is listed as marketed.

199019952000200520102015202020252030203501brand 1993data datePatent 9617303 listed to expire 22 March 2028Patent 8921326 listed to expire 5 February 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 March 2028Patent 9617303
  • 5 February 2031Patent 8921326 drug product

Injectable, Injection

Brand listed, no generic listed as marketed

Brand listed as marketed: Lupron Depot. No generic is listed as marketed.

1985199019952000200520102015202020252030203501brand 1989data datePatent 9617303 listed to expire 22 March 2028Patent 8921326 listed to expire 5 February 2031
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 March 2028Patent 9617303
  • 5 February 2031Patent 8921326 drug product

Powder, Subcutaneous

Brand listed, no generic listed as marketed

Brand listed as marketed: Eligard Kit and Fensolvi Kit. No generic is listed as marketed.

200020052010201520202025203020352040204501brand 2002data datePatent 12397120 listed to expire 22 December 2041Patent 11931559 listed to expire 22 December 2041Patent 11771841 listed to expire 22 December 2041
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 22 December 2041Patent 12397120
  • 22 December 2041Patent 11931559 drug substance
  • 22 December 2041Patent 11771841 drug substance

For Suspension, Intramuscular

Brand listed, no generic listed as marketed

Brand listed as marketed: Leuprolide Acetate For Depot Suspension. No generic is listed as marketed.

201520202025203001brand 2018data 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.

Implant, Implantation

Nothing listed as marketed

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

200020052010201520202025203001brand 2000data 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.

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.