Home / Generic availability / Cetrorelix
When will generic Cetrorelix be available?
The FDA lists no patents or exclusivity for cetrorelix, and 6 generic applications are already approved, so generic cetrorelix is available in the United States.
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| CETROTIDE | Brand (NDA) | EMD SERONO INC | 2000-08-11 | reference listed drug, reference standard |
| CETRORELIX ACETATE | Generic (ANDA) | LIVZON GROUP PHARMACEUTICAL FACTORY | 2024-04-24 | |
| CETRORELIX ACETATE | Generic (ANDA) | TEVA PHARMACEUTICALS INC | 2022-08-12 | |
| CETRORELIX ACETATE | Generic (ANDA) | QILU PHARMACEUTICAL CO LTD | 2024-04-16 | |
| CETRORELIX ACETATE | Generic (ANDA) | XIROMED PHARMA ESPANA SL | 2025-06-03 | |
| CETRORELIX ACETATE | Generic (ANDA) | GLAND PHARMA LTD | 2024-04-25 | |
| CETRORELIX ACETATE | Generic (ANDA) | EPIC PHARMA LLC | 2026-04-29 |
What a generic Cetrorelix would have to match
How it is supplied
HOW SUPPLIED Cetrotide ® (cetrorelix acetate for injection) 0.25 mg is available in a carton of one packaged tray (NDC 44087-1225-1). Each packaged tray contains: one glass vial containing 0.26 - 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, one 20 gauge needle (yellow) and one 27 gauge needle (grey). Storage Store Cetrotide ® 0.25 mg refrigerated, 2ºC - 8ºC (36ºF - 46ºF). Store the packaged tray in the outer carton in order to protect from light.
Storage
Storage Store Cetrotide ® 0.25 mg refrigerated, 2ºC - 8ºC (36ºF - 46ºF). Store the packaged tray in the outer carton in order to 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 2025-09-22.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Cosyntropinno patent or exclusivity listed
- Enfuvirtideno patent or exclusivity listed
- Eptifibatideno patent or exclusivity listed
- Ganirelixno patent or exclusivity listed
- Goserelinno patent or exclusivity listed
Frequently asked questions
When will generic Cetrorelix be available?
The FDA lists no patents or exclusivity for cetrorelix, and 6 generic applications are already approved, so generic cetrorelix 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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