LEXIVA Drug Patent Profile

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.

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:	510
Formulation / Manufacturing:	see details
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

See drug prices 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

Anatomical Therapeutic Chemical (ATC) Classes for LEXIVA

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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
Viiv Hlthcare	LEXIVA	fosamprenavir calcium	TABLET;ORAL	021548-001	Oct 20, 2003		DISCN	Yes	No

Expired US Patents for LEXIVA

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

International Patents for LEXIVA

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

Country	Patent Number	Title	Estimated Expiration
Austria	382042
Australia	755087
Malaysia	131525	SULPHONAMIDE DERIVATIVES AS PRODRUGS OF ASPARTYL PROTEASE INHIBITORS
Norway	329676
Czech Republic	20002363

Supplementary Protection Certificates for LEXIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0933372	CA 2008 00027	Denmark
0933372	08C0015	France		PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
0933372	91426	Luxembourg		91426, EXPIRES: 20190712
0933372	SPC012/2008	Ireland		SPC012/2008: 20091119, EXPIRES: 20190711
0933372	SPC/GB08/018	United Kingdom		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