FDA Orange Book · active-ingredient family
Ganirelix acetate
Ganirelix acetate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GANIRELIX ACETATE · NDA 021057
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANIRELIX ACETATERLD | ORGANON USA ORGANON | NDA 021057 | AP | Jul 29, 1999 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GANIRELIX ACETATE | TRIS PHARMA INC | ANDA 219454 | — | Jun 27, 2025 | |
| GANIRELIX ACETATE | QILU | ANDA 218855 | AP | Apr 23, 2025 | |
| GANIRELIX ACETATE | LUPIN | ANDA 216075 | AP | Nov 16, 2023 | |
| GANIRELIX ACETATE | GLAND | ANDA 215658 | AP | Feb 28, 2023 | |
| GANIRELIX ACETATE | MEITHEAL | ANDA 214996 | AP | Jun 06, 2022 | |
| GANIRELIX ACETATE | AMPHASTAR PHARMS INC | ANDA 212613 | AP | Apr 07, 2022 | |
| FYREMADEL | SUN PHARM | ANDA 204246 | AP | Nov 30, 2018 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ganirelix acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
