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Last Updated: June 6, 2020

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LEXIVA Drug 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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in forty-six 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. Additional details are available on the fosamprenavir calcium profile page.

Paragraph IV (Patent) Challenges for LEXIVA
Tradename Dosage Ingredient NDA Submissiondate
LEXIVA TABLET;ORAL fosamprenavir calcium 021548 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 RX Yes Yes   Start Trial   Start Trial   Start Trial
Viiv Hlthcare LEXIVA fosamprenavir calcium TABLET;ORAL 021548-001 Oct 20, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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

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

Supplementary Protection Certificates for LEXIVA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 08C0015 France   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372 SPC/GB08/018 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
McKesson
Harvard Business School
Dow
Merck

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