FDA Orange Book · active-ingredient family
Ganirelix acetate
Ganirelix acetate: 1 brand, 7 generics; first approved Jul 29, 1999; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
8
Brand (NDA) products
Originator applications
- GANIRELIX ACETATERLDRSORGANON USA ORGANONNDA 0210571999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP
Generic (ANDA) products (7)
Abbreviated applications
- GANIRELIX ACETATETRIS PHARMA INCANDA 2194542025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Discontinued — - GANIRELIX ACETATEQILUANDA 2188552025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP - GANIRELIX ACETATELUPINANDA 2160752023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP - GANIRELIX ACETATEGLANDANDA 2156582023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP - GANIRELIX ACETATEMEITHEALANDA 2149962022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP - GANIRELIX ACETATEAMPHASTAR PHARMS INCANDA 2126132022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION Rx AP - SUN PHARMANDA 2042462018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MCG/0.5ML INJECTABLE INJECTION 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
27 yr 7 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1999–2025 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Ganirelix 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.
