Orange Book product · Brand (NDA)
FIRMAGON
DEGARELIX ACETATE
At a glance
Dec 24, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 2008
17 yr 9 mo ago
Today
Patent 10729739 expires
Listed method-of-use patent (U-1978) expiration.
Feb 10, 2029
in 2 yr 8 mo
Patent 10973870 expires
Listed method-of-use patent (U-1978) expiration.
Feb 10, 2029
in 2 yr 8 mo
Patent 9579359 expires
Listed method-of-use patent (U-1978) expiration.
Feb 10, 2029
in 2 yr 8 mo
Patent 12514898 expires
Listed method-of-use patent (U-1978) expiration.
Feb 20, 2029
in 2 yr 9 mo
Patent 12533387 expires
Listed method-of-use patent (U-4417) expiration.
Feb 20, 2029
in 2 yr 9 mo
Patent 10695398 expires
Listed method-of-use patent (U-1895) expiration.
Apr 27, 2032
in 5 yr 11 mo
Patent 11766468 expires
Listed method-of-use patent (U-1978) expiration.
Apr 27, 2032
in 5 yr 11 mo
Patent 11826397 expires
Listed method-of-use patent (U-1978) expiration.
Apr 27, 2032
in 5 yr 11 mo
Patent 9415085 expires
Listed method-of-use patent (U-1895) expiration.
Apr 27, 2032
in 5 yr 11 mo
Pharmaceutical detail
Active ingredient
DEGARELIX ACETATE
Strength
EQ 80MG BASE/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 022201
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10729739 | Feb 10, 2029 | in 2 yr 8 mo | U-1978 |
| 10973870 | Feb 10, 2029 | in 2 yr 8 mo | U-1978 |
| 9579359 | Feb 10, 2029 | in 2 yr 8 mo | U-1978 |
| 12514898 | Feb 20, 2029 | in 2 yr 9 mo | U-1978 |
| 12533387 | Feb 20, 2029 | in 2 yr 9 mo | U-4417 |
| 10695398 | Apr 27, 2032 | in 5 yr 11 mo | U-1895 |
| 11766468 | Apr 27, 2032 | in 5 yr 11 mo | U-1978 |
| 11826397 | Apr 27, 2032 | in 5 yr 11 mo | U-1978 |
| 9415085 | Apr 27, 2032 | in 5 yr 11 mo | U-1895 |
