Is there a generic for Nelfinavir mesylate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Nelfinavir mesylate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Nelfinavir mesylate?

VIRACEPT (NDA 021503, AGOURON PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nelfinavir mesylate are approved?

Nelfinavir mesylate is approved in the following dosage forms: powder, tablet.

FDA Orange Book · active-ingredient family

Nelfinavir mesylate

Nelfinavir mesylate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:VIRACEPT · NDA 021503

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · powder, tablet

Product	Applicant	Application	TE	Approved
VIRACEPTRLD	AGOURON PHARMS	NDA 021503	—	Apr 30, 2003
VIRACEPTRLD	AGOURON PHARMS	NDA 020779	—	Mar 14, 1997
VIRACEPT	AGOURON PHARMS	NDA 020778	—	Mar 14, 1997

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.

Nelfinavir mesylate — frequently asked questions

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

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