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Home / Generic availability / Degarelix

FDA Orange Book · updated 2026-09-23

When will generic Degarelix be available?

Under patent or exclusivity

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. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.

2032-04-27
Last protection expires
9
Patents listed
0
Exclusivity records
1
Generics waiting

Generics already cleared and waiting

A tentative approval means the FDA has already judged the generic to meet its standards but cannot allow marketing yet.

  • CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. tentative approval 2025, application ANDA215791

Patents listed with the FDA

9 unexpired or current listing(s).

PatentExpiresCoversProduct
107297392029-02-10method of useFIRMAGON
109738702029-02-10method of useFIRMAGON
95793592029-02-10method of useFIRMAGON
125148982029-02-20method of useFIRMAGON
125333872029-02-20method of useFIRMAGON
106953982032-04-27method of useFIRMAGON
117664682032-04-27method of useFIRMAGON
118263972032-04-27method of useFIRMAGON
94150852032-04-27method of useFIRMAGON

Approved products

ProductTypeApplicantApproved
FIRMAGONBrand (NDA)FERRING PHARMACEUTICALS INC2008-12-24reference listed drug, reference standard
How to read these dates. They come from the FDA Orange Book, which records the patents a brand has listed and the exclusivity the FDA has granted. The date shown is when the last of those expires. It is an upper bound on protection, not a prediction of when a generic will actually reach pharmacies.

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. 1 generic application already holds tentative FDA approval, meaning the FDA has judged it acceptable and it is waiting on these dates.

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.