Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

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

« Back to Dashboard

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
Pharmacology for NDA: 205065
Mechanism of ActionPhenylalanine Hydroxylase Activators
Breast Cancer Resistance Protein Inhibitors
P-Glycoprotein Inhibitors
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

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

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.

Copyright 2002-2018 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
DrugPatentWatch reviews  
Links

Follow DrugPatentWatch: