Is there a generic for Goserelin acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Goserelin acetate. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Goserelin acetate?

ZOLADEX (NDA 020578, TERSERA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Goserelin acetate are approved?

Goserelin acetate is approved in the following dosage form: implant.

FDA Orange Book · active-ingredient family

Goserelin acetate

Goserelin acetate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ZOLADEX · NDA 020578

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · implant

Product	Applicant	Application	TE	Approved
ZOLADEXRLD	TERSERA	NDA 020578	—	Jan 11, 1996
ZOLADEXRLD	TERSERA	NDA 019726	—	Dec 29, 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.

Goserelin acetate — frequently asked questions

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

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