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Last Updated: October 1, 2020

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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-nine patent family members in nineteen 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 Submissiondate
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Boehringer Ingelheim
Moodys
McKinsey
McKesson

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