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LEXIVA Drug Profile

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

This drug has one hundred and thirteen patent family members in fifty-three countries.

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. There is one tentative approval for this compound. Additional details are available on the fosamprenavir calcium profile page.

Summary for Tradename: LEXIVA

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
SUSPENSION;ORAL022116-001Jun 14, 2007RXYes6,436,989*PED► subscribeY► subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
TABLET;ORAL021548-001Oct 20, 2003RXYes6,514,953*PED► subscribeY► subscribe
Viiv Hlthcare
LEXIVA
fosamprenavir calcium
SUSPENSION;ORAL022116-001Jun 14, 2007RXYes► subscribe► subscribe
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Paragraph IV activity 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
Hungary229596► subscribe
Hong Kong1034261► subscribe
Japan2009102400► 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
/2008Austria► subscribePRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
0339Netherlands► subscribe300339, 20180310, EXPIRES: 20190711
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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.

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