Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Novartis
Express Scripts
Medtronic
US Army
Harvard Business School
Deloitte
Mallinckrodt
UBS

Generated: October 17, 2017

DrugPatentWatch Database Preview

KUVAN Drug Profile

« Back to Dashboard

Which patents cover Kuvan, and when can generic versions of Kuvan launch?

Kuvan is a drug marketed by Biomarin Pharm and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-seven patent family members in twenty 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

US Patents:11
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list34
Clinical Trials: see list34
Patent Applications: see list142
Drug Prices:see details
DailyMed Link:KUVAN 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
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► Subscribe ► 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;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► Subscribe ► 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
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges for KUVAN

Drugname Dosage Strength RLD Submissiondate
sapropterin dihydrochloridePowder for Oral Solution500 mg/packetKuvan12/20/2016
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
7,475,360Method for dynamically providing scroll indicators► Subscribe
8,324,210Pterin analogs► Subscribe
7,601,717Pterin analogs► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: KUVAN

Country Document Number Estimated Expiration
Mexico2009010977► Subscribe
Spain2596827► Subscribe
BrazilPI0416566► Subscribe
Russian Federation2010132278► Subscribe
Japan2012207029► Subscribe
Japan2010523708► Subscribe
Russian Federation2009141618► Subscribe
Mexico2010006025► Subscribe
World Intellectual Property Organization (WIPO)2005049000► Subscribe
Portugal1708690► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Cantor Fitzgerald
UBS
Healthtrust
US Army
Daiichi Sankyo
Covington
Chinese Patent Office
Merck

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot