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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Express Scripts
McKinsey
McKesson
Queensland Health
US Army
Johnson and Johnson
Medtronic

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for Patent: RE43797

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Which drugs does patent RE43797 protect, and when does it expire?

Patent RE43797 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: RE43797
Title:Methods of administering tetrahydrobiopterin
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), Okhamafe; Augustus O. (Concord, CA)
Assignee: Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:13/299,499
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent RE43797
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Drugs Protected by US Patent RE43797

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 RE43797

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
7,612,073 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring ➤ Sign Up
7,475,360 Method for dynamically providing scroll indicators ➤ Sign Up
7,947,681 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring ➤ Sign Up
7,601,717 Pterin analogs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Family Members for US Patent RE43797

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Slovenia 2139485 ➤ Sign Up
Russian Federation 2486899 ➤ Sign Up
Russian Federation 2009141618 ➤ Sign Up
Russian Federation 2470642 ➤ 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:

Teva
AstraZeneca
Fish and Richardson
Fuji
McKesson
Harvard Business School
Dow
Federal Trade Commission
Deloitte

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