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Generated: June 25, 2018

DrugPatentWatch Database Preview

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 four 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. Five 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
Therapeutic Class:	Antivirals
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021548

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

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	REMEDYREPACK INC.	49349-811	N	49349-811-02
LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548	NDA	ViiV Healthcare Company	49702-207	N	49702-207-18

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:	➤ Sign Up	Patent Expiration:	Jun 24, 2018	Product Flag?		Substance Flag?		Delist Request?
Patent:	➤ Sign Up	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	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.