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Last Updated: April 14, 2021

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Fosamprenavir calcium - Generic Drug Details

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What are the generic sources for fosamprenavir calcium and what is the scope of patent protection?

Fosamprenavir calcium is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Mylan, and Sun Pharm, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fosamprenavir calcium has fifty-seven patent family members in forty-six countries.

There are four drug master file entries for fosamprenavir calcium. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fosamprenavir calcium
Recent Clinical Trials for fosamprenavir calcium

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2/Phase 3

See all fosamprenavir calcium clinical trials

Generic filers with tentative approvals for FOSAMPRENAVIR CALCIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial700MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for FOSAMPRENAVIR CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
LEXIVA TABLET;ORAL fosamprenavir calcium 021548 2012-01-18

US Patents and Regulatory Information for fosamprenavir calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan FOSAMPRENAVIR CALCIUM fosamprenavir calcium TABLET;ORAL 204060-001 Apr 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm FOSAMPRENAVIR CALCIUM fosamprenavir calcium TABLET;ORAL 204024-001 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
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 fosamprenavir calcium

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

Supplementary Protection Certificates for fosamprenavir calcium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0933372 13/2008 Austria   Start Trial 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 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
0933372 PA2008006,C0933372 Lithuania   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001-002 20040712
0933372 08C0015 France   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIQUE; REG. NO/DATE: EU/1/07/282/001-002 20040712
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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