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KUVAN Drug Profile

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Kuvan is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has forty-two patent family members in seventeen countries.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

Summary for Tradename: KUVAN

Patents:11
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYes9,433,624► subscribe ► subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYes7,947,681*PED► subscribeY► subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYes► subscribe► subscribe
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Paragraph IV activity for: KUVAN

Drugname Dosage Strength RLD Submissiondate
sapropterin dihydrochloridePowder for Oral Solution100 mg per packetKuvan11/9/2015
sapropterin dihydrochlorideTablets100 mgKuvan5/30/2014

Non-Orange Book Patents for Tradename: KUVAN

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
7,601,717Pterin analogs► subscribe
8,324,210Pterin analogs► 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 Tradename: KUVAN

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005049000► subscribe
Russian Federation2010132278► subscribe
BrazilPI0809470► 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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