Home / Generic availability / Ganirelix
When will generic Ganirelix be available?
The FDA lists no patents or exclusivity for ganirelix, and 7 generic applications are already approved, so generic ganirelix is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| GANIRELIX ACETATE | Brand (NDA) | ORGANON USA LLC A SUB OF ORGANON AND CO | 1999-07-29 | reference listed drug, reference standard |
| FYREMADEL | Generic (ANDA) | SUN PHARMACEUTICAL INDUSTRIES LTD | 2018-11-30 | |
| GANIRELIX ACETATE | Generic (ANDA) | AMPHASTAR PHARMACEUTICALS INC | 2022-04-07 | |
| GANIRELIX ACETATE | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2022-06-06 | |
| GANIRELIX ACETATE | Generic (ANDA) | GLAND PHARMA LTD | 2023-02-28 | |
| GANIRELIX ACETATE | Generic (ANDA) | LUPIN LTD | 2023-11-16 | |
| GANIRELIX ACETATE | Generic (ANDA) | QILU PHARMACEUTICAL CO LTD | 2025-04-23 | |
| GANIRELIX ACETATE | Generic (ANDA) | TRIS PHARMA INC | 2025-06-27 |
What a generic Ganirelix would have to match
How it is supplied
HOW SUPPLIED Ganirelix Acetate Injection is supplied in: Disposable, ready for use, single dose, sterile, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubber piston that does not contain latex. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge × 1/2-inch needle closed by a needle shield. Packaging components of this product are free from dry natural rubber/latex. Single syringe NDC 83301-0082-1 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Storage
Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
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 2026-05-11.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Goserelinno patent or exclusivity listed
- Icatibantno patent or exclusivity listed
- Oxytocinno patent or exclusivity listed
- Pramlintideno patent or exclusivity listed
- Secretinno patent or exclusivity listed
Frequently asked questions
When will generic Ganirelix be available?
The FDA lists no patents or exclusivity for ganirelix, and 7 generic applications are already approved, so generic ganirelix is available in the United States.
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.
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