Details for New Drug Application (NDA): 021548

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NDA 021548 describes LEXIVA, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LEXIVA profile page.

The generic ingredient in LEXIVA is fosamprenavir calcium. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fosamprenavir calcium profile page.

Summary for 021548

Tradename:	LEXIVA
Applicant:	Viiv Hlthcare
Ingredient:	fosamprenavir calcium
Patents:	2
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021548

Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A4 Inducers P-Glycoprotein Inducers HIV Protease Inhibitors

Suppliers and Packaging for NDA: 021548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548	NDA	ViiV Healthcare Company	49702-207	49702-207-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18)
LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548	NDA	State of Florida DOH Central Pharmacy	53808-0281	53808-0281-1	30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0281-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 700MG BASE
Approval Date:	Oct 20, 2003	TE:	AB	RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Jun 24, 2018	Product Flag?		Substance Flag?		Delist Request?
Patent:	➤ Try a Free Trial	Patent Expiration:	Jan 15, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021548

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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