Home / Generic availability / Degarelix
When will generic Degarelix be available?
Based on the patents and exclusivity the FDA lists today, generic degarelix cannot be marketed in the United States before 2032-04-27, when the last listed protection expires.
Patents listed with the FDA
9 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10729739 | 2029-02-10 | method of use | FIRMAGON |
| 10973870 | 2029-02-10 | method of use | FIRMAGON |
| 9579359 | 2029-02-10 | method of use | FIRMAGON |
| 12514898 | 2029-02-20 | method of use | FIRMAGON |
| 12533387 | 2029-02-20 | method of use | FIRMAGON |
| 10695398 | 2032-04-27 | method of use | FIRMAGON |
| 11766468 | 2032-04-27 | method of use | FIRMAGON |
| 11826397 | 2032-04-27 | method of use | FIRMAGON |
| 9415085 | 2032-04-27 | method of use | FIRMAGON |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| FIRMAGON | Brand (NDA) | FERRING PHARMACEUTICALS INC | 2008-12-24 | reference listed drug, reference standard |
What a generic Degarelix would have to match
Forms and strengths
For injection: FIRMAGON (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in two prefilled syringes. FIRMAGON (80 mg): One single-dose vial delivering 80 mg of degarelix in a white to off-white lyophilized powder for reconstitution supplied with diluent in one prefilled syringe. For injection: FIRMAGON (240 mg): Two single-dose vials each delivering 120 mg of degarelix in a lyophilized powder for reconstitution supplied with diluent in two prefilled syringes ( 3 ) FIRMAGON (80 mg): One single-dose vial delivering 80 mg of degarelix in a lyophilized powder for reconstitution supplied with diluent in one prefilled syringe ( 3 )
How it is supplied
FIRMAGON is available as: NDC 55566-8403-1, Starting dose, One carton contains: Two single-dose vials each delivering 120 mg of degarelix in a white to off-white lyophilized powder for injection Two prefilled syringes each containing 3 mL of Sterile Water for Injection, USP Two vial adapters Two administration needles NDC 55566-8303-1, Maintenance dose, One carton contains: One single-dose vial delivering 80 mg of degarelix in a white to off-white lyophilized powder for injection One prefilled syringe containing 4.2 mL of Sterile Water for Injection, USP One vial adapter One administration needle Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)....
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
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 2024-01-30.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Desmopressinprotection runs to May 2029
- Triptorelinprotection runs to June 2029
- Afamelanotideprotection runs to January 2033
- Bremelanotideprotection runs to November 2033
- Vasopressinprotection runs to January 2035
Frequently asked questions
When will generic Degarelix be available?
Based on the patents and exclusivity the FDA lists today, generic degarelix cannot be marketed in the United States before 2032-04-27, 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.
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