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Last Updated: November 2, 2024

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. Additional information is available in the individual branded drug profile pages.

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.

Recent Clinical Trials for fosamprenavir calcium

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2/Phase 3

See all fosamprenavir calcium clinical trials

Generic filers with tentative approvals for FOSAMPRENAVIR CALCIUM
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up700MGTABLET;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 Strength NDA ANDAs Submitted Submissiondate
LEXIVA Tablets fosamprenavir calcium 700 mg 021548 1 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 Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm FOSAMPRENAVIR CALCIUM fosamprenavir calcium TABLET;ORAL 204024-001 Nov 20, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare LEXIVA fosamprenavir calcium SUSPENSION;ORAL 022116-001 Jun 14, 2007 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare LEXIVA fosamprenavir calcium TABLET;ORAL 021548-001 Oct 20, 2003 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 SUSPENSION;ORAL 022116-001 Jun 14, 2007 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare LEXIVA fosamprenavir calcium TABLET;ORAL 021548-001 Oct 20, 2003 ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare LEXIVA fosamprenavir calcium TABLET;ORAL 021548-001 Oct 20, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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