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Details for Patent: 9,433,624

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Patent 9,433,624 protects KUVAN and is included in two NDAs. There have been two Paragraph IV challenges on Kuvan.

This patent has eleven patent family members in ten countries.

Summary for Patent: 9,433,624

Title:Methods and compositions for the treatment of metabolic disorders
Abstract: The present invention is directed to a novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. More specifically, the specification describes methods and compositions for treating various types of phenylketonurias using compositions comprising BH4. Combination therapies of BH4 and other therapeutic regimens are contemplated.
Inventor(s): Oppenheimer; Daniel I. (Castro Valley, CA), Kakkis; Emil D. (Novato, CA), Price; Fredric D. (Bedford, NY), Dorenbaum; Alejandro (Mill Valley, CA), Moser; Rudolf (Schaffhausen, CH), Groehn; Viola (Dachsen, CH), Egger; Thomas (Kempthal, CH), Blatter; Fritz (Reinach, CH)
Assignee: BIOMARIN PHARMACEUTICAL INC. (Novato, CA)
Application Number:13/297,644
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYes9,433,624► subscribe METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXNo9,433,624► subscribe METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYes9,433,624► subscribe METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
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Non-Orange Book Patents for Patent: 9,433,624

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,067,416Methods and compositions for the treatment of metabolic disorders► subscribe
7,566,714Methods and compositions for the treatment of metabolic disorders► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 9,433,624

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2004291149► subscribe
BrazilPI0416566► subscribe
Canada2545584► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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