Is there a generic for Fosamprenavir calcium?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Fosamprenavir calcium, referencing the brand LEXIVA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Fosamprenavir calcium?

LEXIVA (NDA 022116, VIIV HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Fosamprenavir calcium are approved?

Fosamprenavir calcium is approved in the following dosage forms: suspension, tablet.

FDA Orange Book · active-ingredient family

Fosamprenavir calcium

Fosamprenavir calcium is approved as 2 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LEXIVA · NDA 022116

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · suspension, tablet

Product	Applicant	Application	TE	Approved
LEXIVARLD	VIIV HLTHCARE	NDA 022116	—	Jun 14, 2007
LEXIVARLD	VIIV HLTHCARE	NDA 021548	—	Oct 20, 2003

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
FOSAMPRENAVIR CALCIUM	SUN PHARM	ANDA 204024	AB	Nov 20, 2019
FOSAMPRENAVIR CALCIUM	MYLAN	ANDA 204060	AB	Apr 15, 2016

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.

Fosamprenavir calcium — frequently asked questions

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

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