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Last Updated: September 24, 2022

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 fifty-five patent family members in twenty-one 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent RE43797

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008240259 See Plans and Pricing
Australia 2008347005 See Plans and Pricing
Brazil PI0809470 See Plans and Pricing
Brazil PI0821970 See Plans and Pricing
Canada 2682598 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Boehringer Ingelheim
Moodys
McKinsey
McKesson

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 verification 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.