Is there a generic for Gonadorelin acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gonadorelin acetate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Gonadorelin acetate?

LUTREPULSE KIT (NDA 019687, FERRING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gonadorelin acetate are approved?

Gonadorelin acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gonadorelin acetate

Gonadorelin acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:LUTREPULSE KIT · NDA 019687

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
LUTREPULSE KIT×2	FERRING	NDA 019687	—	Oct 10, 1989

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.

Gonadorelin acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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