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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Chubb
Dow
QuintilesIMS
Novartis
Fuji
Covington
Farmers Insurance
Harvard Business School

Generated: February 23, 2018

DrugPatentWatch Database Preview

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-six 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

US Patents and Regulatory Information 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 POWDER;ORAL 205065-001 Dec 19, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,475,360 Method for dynamically providing scroll indicators ➤ Sign Up
7,601,717 Pterin analogs ➤ Sign Up
8,324,210 Pterin analogs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for sapropterin dihydrochloride

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Dow
McKinsey
Teva
Covington
Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Cerilliant

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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