Home / Generic availability / Leuprolide
When will generic Leuprolide be available?
Based on the patents and exclusivity the FDA lists today, generic leuprolide cannot be marketed in the United States before 2041-12-22, when the last listed protection expires.
Patents listed with the FDA
20 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10646572 | 2027-01-16 | drug product | CAMCEVI KIT |
| 9744207 | 2027-01-16 | drug product | CAMCEVI KIT |
| 10646572 | 2027-01-16 | drug product | CAMCEVI ETM |
| 9744207 | 2027-01-16 | drug product | CAMCEVI ETM |
| 9617303 | 2028-03-22 | method of use | LUPRON DEPOT-PED KIT |
| 9617303 | 2028-03-22 | method of use | LUPRON DEPOT |
| 9572857 | 2029-08-02 | drug product | CAMCEVI KIT |
| 9572857 | 2029-08-02 | drug product | CAMCEVI ETM |
| 8921326 | 2031-02-05 | drug product | LUPRON DEPOT-PED KIT |
| 8921326 | 2031-02-05 | drug product | LUPRON DEPOT |
| 12133878 | 2037-12-18 | drug product | CAMCEVI KIT |
| 12133878 | 2037-12-18 | drug product | CAMCEVI ETM |
| 11717555 | 2039-01-01 | drug product | CAMCEVI KIT |
| 11717555 | 2039-01-01 | drug product | CAMCEVI ETM |
| 11771841 | 2041-12-22 | drug substance, drug product | FENSOLVI KIT |
| 11931559 | 2041-12-22 | drug substance | FENSOLVI KIT |
| 12397120 | 2041-12-22 | method of use | FENSOLVI KIT |
| 11771841 | 2041-12-22 | drug substance, drug product | ELIGARD KIT |
| 11931559 | 2041-12-22 | drug substance | ELIGARD KIT |
| 12397120 | 2041-12-22 | method of use | ELIGARD KIT |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| NS | 2026-04-14 | New strength | LUPRON DEPOT-PED KIT |
| NS | 2028-08-25 | New strength | CAMCEVI ETM |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| LUPRON | Brand (NDA) | ABBVIE ENDOCRINE INC | 1985-04-09 | reference listed drug |
| LUPRON DEPOT | Brand (NDA) | ABBVIE ENDOCRINE INC | 1989-01-26 | reference listed drug, reference standard |
| LUPRON DEPOT | Brand (NDA) | ABBVIE ENDOCRINE INC | 1990-10-22 | reference listed drug, reference standard |
| LUPRON DEPOT-PED KIT | Brand (NDA) | ABBVIE ENDOCRINE INC | 1993-04-16 | reference listed drug, reference standard |
| LUPRON DEPOT | Brand (NDA) | ABBVIE ENDOCRINE INC | 1995-12-22 | reference listed drug, reference standard |
| LUPRON DEPOT | Brand (NDA) | ABBVIE ENDOCRINE INC | 1997-03-07 | reference listed drug, reference standard |
| VIADUR | Brand (NDA) | ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC | 2000-03-03 | |
| ELIGARD KIT | Brand (NDA) | TOLMAR INC | 2002-01-23 | reference listed drug, reference standard |
| ELIGARD KIT | Brand (NDA) | TOLMAR INC | 2002-07-24 | reference listed drug, reference standard |
| ELIGARD KIT | Brand (NDA) | TOLMAR INC | 2003-02-13 | reference listed drug, reference standard |
| ELIGARD KIT | Brand (NDA) | TOLMAR INC | 2004-12-14 | reference listed drug, reference standard |
| LEUPROLIDE ACETATE | Generic (ANDA) | SANDOZ INC | 1998-08-04 | reference standard |
| LEUPROLIDE ACETATE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2000-10-25 | |
| LEUPROLIDE ACETATE | Generic (ANDA) | GENZYME CORPORATION | 2001-11-29 | |
| LEUPROLIDE ACETATE | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2009-03-09 | |
| LUPANETA PACK | Brand (NDA) | ABBVIE ENDOCRINE INC | 2012-12-14 | reference listed drug |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | Brand (NDA) | INVAGEN PHARMACEUTICALS INC | 2018-08-28 | reference listed drug, reference standard |
| CAMCEVI KIT | Brand (NDA) | ACCORD BIOPHARMA INC | 2021-05-25 | reference listed drug, reference standard |
| LEUPROLIDE ACETATE | Generic (ANDA) | EUGIA PHARMA SPECIALITIES LTD | 2022-06-06 | |
| FENSOLVI KIT | Brand (NDA) | TOLMAR INTERNATIONAL LTD | 2020-05-01 | reference listed drug, reference standard |
| VOBRIG | Brand (NDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2026-08-26 | reference listed drug, reference standard |
| LEUPROLIDE ACETATE | Generic (ANDA) | SOMERSET THERAPEUTICS LLC | 2021-08-13 | |
| LEUPROLIDE ACETATE | Generic (ANDA) | AMNEAL EU LTD | 2022-10-28 | |
| LEUPROLIDE ACETATE | Generic (ANDA) | ZYDUS PHARMACEUTICALS USA INC | 2025-11-13 |
Frequently asked questions
When will generic Leuprolide be available?
Based on the patents and exclusivity the FDA lists today, generic leuprolide cannot be marketed in the United States before 2041-12-22, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.