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Serving 500+ biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Julphar
Farmers Insurance
Queensland Health
Johnson and Johnson
Fish and Richardson
Harvard Business School
Chinese Patent Office
Argus Health

Generated: September 25, 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-one 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 Generic Name: sapropterin dihydrochloride

Tradenames:1
Patents:11
Applicants:1
NDAs:2
Drug Master File Entries: see list3
Suppliers / Packagers: see list1
Bulk Api Vendors: see list44
Clinical Trials: see list82
Patent Applications: see list256
Therapeutic Class:Enzyme Replacements/Modifiers
Drug Prices:see low prices
DailyMed Link:sapropterin dihydrochloride at DailyMed
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► Subscribe► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► SubscribeY► 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► SubscribeY► 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
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► 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
Mexico2010006025► Subscribe
World Intellectual Property Organization (WIPO)2005049000► Subscribe
South Korea20150080026► Subscribe
South Korea101721198► Subscribe
Denmark1708690► Subscribe
Denmark2139485► Subscribe
Canada2545584► Subscribe
Canada2682598► Subscribe
Australia2008240259► Subscribe
Spain2524026► 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 500+ biopharmaceutical companies globally:

Julphar
Express Scripts
Mallinckrodt
Novartis
Medtronic
Covington
Cipla
Johnson and Johnson
US Department of Justice
Colorcon

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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