Is there a generic for Amprenavir?

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

What is the reference-listed drug for Amprenavir?

AGENERASE (NDA 021039, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amprenavir are approved?

Amprenavir is approved in the following dosage forms: capsule, solution.

FDA Orange Book · active-ingredient family

Amprenavir

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

Reference-listed drug:AGENERASE · NDA 021039

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, solution

Product	Applicant	Application	TE	Approved
AGENERASERLD	GLAXOSMITHKLINE	NDA 021039	—	Apr 15, 1999
AGENERASE×2	GLAXOSMITHKLINE	NDA 021007	—	Apr 15, 1999

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.

Amprenavir — frequently asked questions

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

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