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FDA Orange Book · active-ingredient family

Degarelix acetate

Degarelix acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:FIRMAGON · NDA 022201

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
FIRMAGONRLD×2FERRINGNDA 022201Dec 24, 2008

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9579359Feb 10, 2029in 2 yr 8 mo
U-1978
10973870Feb 10, 2029in 2 yr 8 mo
U-1978
10729739Feb 10, 2029in 2 yr 8 mo
U-1978
12514898Feb 20, 2029in 2 yr 9 mo
U-1978
12533387Feb 20, 2029in 2 yr 9 mo
U-4417
10695398Apr 27, 2032in 5 yr 11 mo
U-1895
9415085Apr 27, 2032in 5 yr 11 mo
U-1895
11766468Apr 27, 2032in 5 yr 11 mo
U-1978
11826397Apr 27, 2032in 5 yr 11 mo
U-1978

Degarelix acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.