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Last Updated: March 29, 2024

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.

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

This patent has sixteen patent family members in fourteen countries.

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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,003,126
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;

Drugs Protected by US Patent 8,003,126

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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

International Family Members for US Patent 8,003,126

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 052238 ⤷  Try a Trial
Australia 2005306686 ⤷  Try a Trial
Brazil PI0517088 ⤷  Try a Trial
Canada 2581814 ⤷  Try a Trial
China 101132776 ⤷  Try a Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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