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Serving leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Medtronic
Deloitte
UBS
McKinsey
Moodys
Healthtrust
Fish and Richardson
McKesson

Generated: November 22, 2017

DrugPatentWatch Database Preview

LEXIVA Drug Profile

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What is the patent landscape for Lexiva, and what generic Lexiva alternatives are available?

Lexiva is a drug marketed by Viiv Hlthcare and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty patent family members in fifty-three countries and eleven supplementary protection certificates in ten countries.

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.
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;ORAL022116-001Jun 14, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003ABRXYesYes► Subscribe► SubscribeY► Subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for LEXIVA

Drugname Dosage Strength RLD Submissiondate
fosamprenavir calciumTablets700 mgLexiva1/18/2012

Non-Orange Book Patents for Tradename: LEXIVA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,559,137 Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► Subscribe
7,592,368Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► Subscribe
6,838,474 Sulphonamide derivatives as prodrugs of aspartyl protease inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LEXIVA

Country Document Number Estimated Expiration
Slovenia1098898► Subscribe
Eurasian Patent Organization200000703► Subscribe
Colombia5090836► Subscribe
TunisiaSN99145► Subscribe
Portugal1098898► Subscribe
Spain2189450► Subscribe
Norway2009008► Subscribe
China1284071► Subscribe
Denmark0933372► Subscribe
Colombia4990992► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LEXIVA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4Finland► Subscribe
C/GB08/018United Kingdom► SubscribePRODUCT 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
0339Netherlands► Subscribe300339, 20180310, EXPIRES: 20190711
C012/2008Ireland► SubscribeSPC012/2008: 20091119, EXPIRES: 20190711
426Luxembourg► Subscribe91426, EXPIRES: 20190712
2008 00027Denmark► Subscribe
2008006,C0933372Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
2008006Lithuania► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372/01Switzerland► SubscribePRODUCT NAME: FOSAMPRENAVIR; REGISTRATION NUMBER/DATE: SWISSMEDIC 56706 17.03.2005
C0015France► SubscribePRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Cantor Fitzgerald
Harvard Business School
Johnson and Johnson
UBS
Merck
Argus Health
Chubb
Federal Trade Commission
Queensland Health

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.

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