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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Mallinckrodt
Citi
McKinsey
Cipla
Cerilliant
McKesson
Baxter
AstraZeneca

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,067,416

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Which drugs does patent 8,067,416 protect, and when does it expire?

Patent 8,067,416 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 sixteen patent family members in seventeen countries.
Summary for Patent: 8,067,416
Title:Methods and compositions for the treatment of metabolic disorders
Abstract: The present invention is directed to a novel methods and compositions for the therapeutic intervention in hyperphenylalaninemia. More specifically, the specification describes methods and compositions for treating various types of phenylketonurias using compositions comprising BH4. Combination therapies of BH4 and other therapeutic regimens are contemplated.
Inventor(s): Oppenheimer; Daniel I. (Castro Valley, CA), Kakkis; Emil D. (Novato, CA), Price; Fredric D. (Bedford, NY), Dorenbaum; Alejandro (Mill Valley, CA), Moser; Rudolf (Schaffhausen, CH), Groehn; Viola (Dachsen, CH), Egger; Thomas (Kempthal, CH), Blatter; Fritz (Reinach, CH)
Assignee: Merck Eprova AG (Schaffhausen, CH) Biomarin Pharmaceutical Inc. (Novato, CA)
Application Number:12/508,209
Patent Claim Types:
see list of patent claims
Use; Delivery;

Drugs Protected by US Patent 8,067,416

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 8,067,416

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
7,566,714 Methods and compositions for the treatment of metabolic disorders ➤ Sign Up
9,433,624 Methods and compositions for the treatment of metabolic disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Accenture
Teva
Farmers Insurance
Mallinckrodt
US Army
QuintilesIMS
Moodys
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 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.