Is there a generic for Sermorelin acetate?

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

What is the reference-listed drug for Sermorelin acetate?

GEREF (NDA 020443, EMD SERONO INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sermorelin acetate are approved?

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

FDA Orange Book · active-ingredient family

Sermorelin acetate

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

Reference-listed drug:GEREF · NDA 020443

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
GEREFRLD×2	EMD SERONO INC	NDA 020443	—	Sep 26, 1997
GEREFRLD	EMD SERONO	NDA 019863	—	Dec 28, 1990

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.

Sermorelin acetate — frequently asked questions

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

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