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Serving leading biopharmaceutical companies globally:

US Army
Teva
Citi
Cerilliant
McKinsey
US Department of Justice
Healthtrust
Chinese Patent Office
QuintilesIMS
Medtronic

Generated: November 21, 2017

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Sapropterin dihydrochloride - Generic Drug Details

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What are the generic sources for sapropterin dihydrochloride and what is the scope of sapropterin dihydrochloride freedom to operate?

Sapropterin dihydrochloride
is the generic ingredient in one branded drug marketed by Biomarin Pharm and is included in two NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has fifty-seven patent family members in twenty countries.

There are three drug master file entries for sapropterin dihydrochloride. One supplier is listed for this compound.

Summary for sapropterin dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► Subscribe► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► Subscribe► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sapropterin dihydrochloride

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
7,475,360Method for dynamically providing scroll indicators► Subscribe
8,324,210Pterin analogs► Subscribe
7,601,717Pterin 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 Ingredient: sapropterin dihydrochloride

Country Document Number Estimated Expiration
South Korea20070005550► Subscribe
BrazilPI0809470► Subscribe
Russian Federation2009141618► Subscribe
Russian Federation2486899► Subscribe
South Korea20160064248► Subscribe
South Korea101721198► Subscribe
European Patent Office2139485► Subscribe
Japan2013163691► Subscribe
Japan2011508775► Subscribe
Australia2004291149► 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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Boehringer Ingelheim
Accenture
QuintilesIMS
AstraZeneca
Novartis
Deloitte
Cerilliant
Fuji

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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