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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Boehringer Ingelheim
Argus Health
Cantor Fitzgerald

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,003,126

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Which drugs does patent 8,003,126 protect, and when does it expire?

Patent 8,003,126 protects KUVAN and is included in one NDA. There have been three Paragraph IV challenges on Kuvan.

Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,003,126

Title:Stable tablet formulation
Abstract: The present invention is directed to a stable solid formulations of tetrahydrobiopterin, processes for producing them, and treatment methods using such formulations.
Inventor(s): Jungles; Steven (Novato, CA), Henderson; Mark (Larkspur, CA), Sluzky; Victoria (Corte Madera, CA), Baffi; Robert (Moraga, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:10/563,418
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
Biomarin PharmKUVANsapropterin dihydrochlorideTABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► Subscribe► SubscribeY
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Foreign Priority and PCT Information for Patent: 8,003,126

PCT Information
PCT FiledNovember 16, 2005PCT Application Number:PCT/US2005/041252
PCT Publication Date:May 26, 2006PCT Publication Number: WO2006/055511

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Queensland Health
Cantor Fitzgerald
Boehringer Ingelheim

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