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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Cerilliant
McKinsey
Queensland Health
Healthtrust
Johnson and Johnson
US Army
Deloitte
Fuji

Generated: December 16, 2017

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. There have been three Paragraph IV challenges on Kuvan.

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 Claim Types:
see list of patent claims
Use; Dosage form;

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 PharmKUVANsapropterin dihydrochloridePOWDER;ORAL205065-001Dec 19, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Biomarin PharmKUVANsapropterin dihydrochloridePOWDER;ORAL205065-002Oct 27, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Biomarin PharmKUVANsapropterin dihydrochlorideTABLET;ORAL022181-001Dec 13, 2007RXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents 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
7,475,360Method for dynamically providing scroll indicators► Subscribe
7,947,681Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring► Subscribe
8,324,210Pterin analogs► Subscribe
7,612,073Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring► 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 Patent: RE43797

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2008240259► Subscribe
Australia2008347005► Subscribe
BrazilPI0809470► Subscribe
BrazilPI0821970► Subscribe
Canada2682598► Subscribe
Canada2711160► Subscribe
China101678025► Subscribe
China101969953► Subscribe
Cyprus1113543► Subscribe
Denmark2139485► 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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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
Fuji
Federal Trade Commission
Moodys
Julphar
Accenture
Colorcon
Express Scripts
Johnson and Johnson

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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