LEXIVA Drug Patent Profile

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When do Lexiva patents expire, and when can generic versions of Lexiva launch?

Lexiva is a drug marketed by Viiv Hlthcare and is included in two NDAs.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexiva

A generic version of LEXIVA was approved as fosamprenavir calcium by MYLAN on April 15^th, 2016.

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Summary for LEXIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	12
Patent Applications:	427
Drug Prices:	Drug price information for LEXIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LEXIVA
What excipients (inactive ingredients) are in LEXIVA?	LEXIVA excipients list
DailyMed Link:	LEXIVA at DailyMed

Drug patent expirations by year for LEXIVA

Recent Clinical Trials for LEXIVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical College of Wisconsin	Phase 3
ViiV Healthcare	Phase 1
GlaxoSmithKline	Phase 1

See all LEXIVA clinical trials

Pharmacology for LEXIVA

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

Paragraph IV (Patent) Challenges for LEXIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXIVA	Tablets	fosamprenavir calcium	700 mg	021548	1	2012-01-18

US Patents and Regulatory Information for LEXIVA

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LEXIVA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	SUSPENSION;ORAL	022116-001	Jun 14, 2007	⤷ Sign Up	⤷ Sign Up
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003	⤷ Sign Up	⤷ Sign Up
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

International Patents for LEXIVA

See the table below for patents covering LEXIVA around the world.

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Country	Patent Number	Title	Estimated Expiration
Panama	8477801	(3S) TETRAHIDRO-3-FURANIL (1S,2R)-3-[[4-AMINOFENIL) SULFONIL)] (ISOBUTIL) AMINO]-1-BENCIL-2-(FOSFONOOXI) PROPILCARBAMATO DE CALCIO	⤷ Sign Up
Bulgaria	105253		⤷ Sign Up
Slovenia	1098898		⤷ Sign Up
Colombia	4990992	PROFARMACOS DE COMPUESTOS DE SULFONAMIDA COMO INHIBIDORES DE ASPARTIL PROTEASA	⤷ Sign Up
Czech Republic	301653	Deriváty sulfonamidu a farmaceutický prostredek, který je obsahuje (Sulfonamide derivatives and pharmaceutical composition which the derivatives are comprised)	⤷ Sign Up
Hungary	0101831		⤷ Sign Up
Yugoslavia	3401		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LEXIVA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	SPC/GB08/018	United Kingdom	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
0933372	13/2008	Austria	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
0933372	SPC012/2008	Ireland	⤷ Sign Up	SPC012/2008: 20091119, EXPIRES: 20190711
0933372	91426	Luxembourg	⤷ Sign Up	91426, EXPIRES: 20190712
0933372	300339	Netherlands	⤷ Sign Up	300339, 20180310, EXPIRES: 20190711
0933372	C00933372/01	Switzerland	⤷ Sign Up	PRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
0933372	CA 2008 00027	Denmark	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description