Is there a generic for Saquinavir mesylate?

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

What is the reference-listed drug for Saquinavir mesylate?

INVIRASE (NDA 021785, HOFFMANN-LA ROCHE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Saquinavir mesylate are approved?

Saquinavir mesylate is approved in the following dosage forms: capsule, tablet.

FDA Orange Book · active-ingredient family

Saquinavir mesylate

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

Reference-listed drug:INVIRASE · NDA 021785

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, tablet

Product	Applicant	Application	TE	Approved
INVIRASERLD	HOFFMANN-LA ROCHE	NDA 021785	—	Dec 17, 2004
INVIRASERLD	HOFFMANN LA ROCHE	NDA 020628	—	Dec 06, 1995

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.

Saquinavir mesylate — frequently asked questions

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

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