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Serving leading biopharmaceutical companies globally:

Julphar
McKinsey
McKesson
Queensland Health
Harvard Business School
AstraZeneca
Mallinckrodt
Novartis
Fish and Richardson
Cantor Fitzgerald

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for Patent: 7,612,073

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Which drugs does patent 7,612,073 protect, and when does it expire?

Patent 7,612,073 protects KUVAN and is included in two NDAs.

Protection for KUVAN has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-four patent family members in eighteen countries.
Summary for Patent: 7,612,073
Title:Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Abstract:The present invention is directed to treatment methods of administering tetrahydrobiopterin, including in oral dosage forms, in intravenous formulations, and with food. Also disclosed herein are biopterin assays for measuring the amount of biopterin and metabolites of biopterin in a sample.
Inventor(s): Oppenheimer; Daniel I. (Castro Valley, CA), Dorenbaum; Alejandro (Mill Valley, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:12/329,838
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Drugs Protected by US Patent 7,612,073

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 7,612,073

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
8,324,210 Pterin analogs ➤ Sign Up
RE43797 Methods of administering tetrahydrobiopterin ➤ Sign Up
7,601,717 Pterin analogs ➤ Sign Up
7,947,681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 7,612,073

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008240259 ➤ Sign Up
Australia 2008347005 ➤ Sign Up
Brazil PI0809470 ➤ Sign Up
Brazil PI0821970 ➤ Sign Up
Canada 2682598 ➤ Sign Up
Canada 2711160 ➤ Sign Up
China 101678025 ➤ Sign Up
China 101969953 ➤ Sign Up
Cyprus 1113543 ➤ Sign Up
Denmark 2139485 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim
Daiichi Sankyo
QuintilesIMS
Chubb
Deloitte
Medtronic
AstraZeneca
Harvard Business School

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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