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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Fuji
Express Scripts
Cantor Fitzgerald
Farmers Insurance
Cipla
Mallinckrodt
Harvard Business School
Chubb

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205065

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NDA 205065 describes KUVAN, which is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KUVAN profile page.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 205065
Tradename:KUVAN
Applicant:Biomarin Pharm
Ingredient:sapropterin dihydrochloride
Patents:6
Therapeutic Class:Enzyme Replacements/Modifiers
Suppliers and Packaging for NDA: 205065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KUVAN sapropterin dihydrochloride POWDER;ORAL 205065 NDA BioMarin Pharmaceutical Inc. 68135-301 N 68135-301-22
KUVAN sapropterin dihydrochloride POWDER;ORAL 205065 NDA BioMarin Pharmaceutical Inc. 68135-482 N 68135-482-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength100MG/PACKET
Approval Date:Dec 19, 2013TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Deloitte
Accenture
Chinese Patent Office
McKinsey
Federal Trade Commission
Covington
Fish and Richardson

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