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Last Updated: November 2, 2024

FOSAMPRENAVIR CALCIUM Drug Patent Profile


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Which patents cover Fosamprenavir Calcium, and what generic alternatives are available?

Fosamprenavir Calcium is a drug marketed by Mylan and Sun Pharm and is included in two NDAs.

The generic ingredient in FOSAMPRENAVIR CALCIUM 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fosamprenavir Calcium

A generic version of FOSAMPRENAVIR CALCIUM was approved as fosamprenavir calcium by MYLAN on April 15th, 2016.

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Drug patent expirations by year for FOSAMPRENAVIR CALCIUM
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

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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