FDA Orange Book · active-ingredient family
Cetrorelix acetate
Cetrorelix acetate is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CETROTIDE · NDA 021197
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CETROTIDERLD×2 | EMD SERONO INC | NDA 021197 | AP | Aug 11, 2000 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CETRORELIX ACETATE | EPIC PHARMA LLC | ANDA 218740 | AP | Apr 29, 2026 | |
| CETRORELIX ACETATE | XIROMED | ANDA 218061 | AP | Jun 03, 2025 | |
| CETRORELIX ACETATE | GLAND | ANDA 218150 | AP | Apr 25, 2024 | |
| CETRORELIX ACETATE | LIVZON GRP | ANDA 214540 | AP | Apr 24, 2024 | |
| CETRORELIX ACETATE | QILU | ANDA 217776 | AP | Apr 16, 2024 | |
| CETRORELIX ACETATE | TEVA PHARMS INC | ANDA 215737 | AP | Aug 12, 2022 |
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.
Cetrorelix acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
