FDA Orange Book · active-ingredient family
Cetrorelix acetate
Cetrorelix acetate: 1 brand, 6 generics; first approved Aug 11, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- EMD SERONO INCNDA 02119720002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP EQ 3MG BASE/VIAL POWDER SUBCUTANEOUS Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- CETRORELIX ACETATEEPIC PHARMA LLCANDA 2187402026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP - CETRORELIX ACETATEXIROMEDANDA 2180612025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP - CETRORELIX ACETATEGLANDANDA 2181502024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP - CETRORELIX ACETATELIVZON GRPANDA 2145402024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP - CETRORELIX ACETATEQILUANDA 2177762024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP - CETRORELIX ACETATETEVA PHARMS INCANDA 2157372022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.25MG BASE/VIAL POWDER SUBCUTANEOUS Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
26 yr 5 mo ago
Most recent approval
4 mo ago
Approvals span 2000–2026 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Cetrorelix 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
