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FDA Orange Book · active-ingredient family

Degarelix acetate

Degarelix acetate: 1 brand, 0 generics; first approved Dec 24, 2008; on patent until Feb 10, 2029.

On patent
Generic status & protection

Protected until Feb 10, 2029 (earliest listed patent expiry).

Earliest patent expiry Feb 10, 2029
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
9
Next patent expiry
Feb 10, 2029
in 2 yr 7 mo
Originator applications

Brand (NDA) products

FIRMAGONRLD
NDA 02220120082 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 80MG BASE/VIALPOWDERSUBCUTANEOUSRx—
EQ 120MG BASE/VIALPOWDERSUBCUTANEOUSRx—
Protection horizon

Patent & exclusivity timeline

20262027202820292030203120322033TodayPatent 9579359 — 2029-02-10Patent 9579359Patent 10973870 — 2029-02-10Patent 10973870Patent 10729739 — 2029-02-10Patent 10729739Patent 12514898 — 2029-02-20Patent 12514898Patent 12533387 — 2029-02-20Patent 12533387Patent 10695398 — 2032-04-27Patent 10695398Patent 9415085 — 2032-04-27Patent 9415085Patent 11766468 — 2032-04-27Patent 11766468Patent 11826397 — 2032-04-27Patent 11826397
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

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 7 mo
U-1978
10973870Feb 10, 2029in 2 yr 7 mo
U-1978
10729739Feb 10, 2029in 2 yr 7 mo
U-1978
12514898Feb 20, 2029in 2 yr 8 mo
U-1978
12533387Feb 20, 2029in 2 yr 8 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
FDA approval span

Approval history

First approval
Dec 24, 2008
17 yr 10 mo ago
Most recent approval
Dec 24, 2008
17 yr 10 mo ago

All 1 application were approved in 2008.

Brand (NDA) 1100%
Generic (ANDA) 00%

Degarelix acetate — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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