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Serving leading biopharmaceutical companies globally:

Novartis
US Department of Justice
Moodys
Federal Trade Commission
Cerilliant
Chubb
Boehringer Ingelheim
Teva
Dow
Citi

Generated: October 21, 2017

DrugPatentWatch Database Preview

Biomarin Pharm Company Profile

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What is the competitive landscape for BIOMARIN PHARM, and what generic alternatives to BIOMARIN PHARM drugs are available?

BIOMARIN PHARM has two approved drugs.

There are eleven US patents protecting BIOMARIN PHARM drugs and there have been two Paragraph IV challenges on BIOMARIN PHARM drugs in the past three years.

There are fifty-one patent family members on BIOMARIN PHARM drugs in twenty countries.

Summary for Applicant: Biomarin Pharm

International Patents:51
US Patents:11
Tradenames:1
Ingredients:1
NDAs:2
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► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► 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► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
TABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin Pharm
KUVAN
sapropterin dihydrochloride
POWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV activity for BIOMARIN PHARM drugs

Drugname Dosage Strength Tradename Submissiondate
sapropterin dihydrochloride
Powder for Oral Solution500 mg/packet
KUVAN
12/20/2016
sapropterin dihydrochloride
Powder for Oral Solution100 mg per packet
KUVAN
11/9/2015
sapropterin dihydrochloride
Tablets100 mg
KUVAN
5/30/2014

Non-Orange Book Patents for Biomarin Pharm

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 Biomarin Pharm Drugs

Country Document Number Estimated Expiration
BrazilPI0416566► Subscribe
South Korea20170037676► Subscribe
Denmark2139485► Subscribe
World Intellectual Property Organization (WIPO)2008128049► Subscribe
China1905863► Subscribe
Japan2012207029► Subscribe
Mexico2010006025► Subscribe
South Korea20150080026► Subscribe
BrazilPI0809470► Subscribe
Japan2013163691► 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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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Colorcon
Mallinckrodt
US Department of Justice
Healthtrust
Teva
Daiichi Sankyo
UBS
Chinese Patent Office

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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