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 |
| 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 |
What a generic Leuprolide would have to match
Forms and strengths
VABRINTY is an injectable suspension of leuprolide acetate available in a pre-connected syringe system and packaged with a sterile safety needle and cap (Table 2), a desiccant, prescribing information and instructions for use. The pre-connected syringe system consists of syringe A and syringe B connected using a coupling device. Syringe A contains the in situ polymeric extended release technology and the syringe B contains leuprolide acetate powder. When reconstituted, VABRINTY is administered as a single dose. Refer to Table 10 for details of the description of the dosage form before and after mixing [see How Supplied/Storage and Handling ( 16 )] . Table 2. Specifications for VABRINTY Sterile Safety Needle and Cap VABRINTY strength Gauge Length 7.5 mg 20-gauge 5/8-inch 22.5 mg 20-gauge 5/8-inch 30 mg 20-gauge 5/8-inch 45 mg 18-gauge 5/8-inch Injectable suspension: 7.5 mg ( 3 )...
How it is supplied
How Supplied VABRINTY is supplied as a single-dose, two syringe-mixing system with a sterile safety needle and cap. VABRINTY is available as follows (Table 10): Table 10. VABRINTY Product Presentations VABRINTY strength NDC number Description of Syringe A with the delivery system Description of Syringe B with leuprolide acetate Description of the suspension after mixing 7.5 mg 85043-075-05 Light tan to tan, clear, viscous solution White to off white powder Light tan to tan 22.5 mg 85043-025-02 Colorless to pale yellow, clear viscous solution White to off white powder Colorless to pale yellow 30 mg 85043-030-03 Colorless to pale yellow, clear viscous solution White to off white powder...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-04-30.
Recalls involving Leuprolide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Tolmar, Inc. | CO | Class III | 2023-09-12 | Superpotent Drug - Higher than expected levels of leuprolide acetate i |
| Perry Drug Inc. | KS | Class II | 2014-11-07 | Lack of sterility assurance;All lots of sterile products compounded by |
| AbbVie Inc | IL | Class II | 2014-03-10 | Defective Delivery System: Some Lupron Depot Kits may contain a syring |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Carfilzomibprotection runs to January 2027
- Exenatideprotection runs to February 2027
- Linaclotideprotection runs to February 2027
- Semaglutideprotection runs to March 2027
- Lanreotideprotection runs to March 2027
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 2026-11-01. 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.
Related data
- Leuprolide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book