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Last Updated: June 4, 2020

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Details for New Drug Application (NDA): 022181

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NDA 022181 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 022181
Applicant:Biomarin Pharm
Ingredient:sapropterin dihydrochloride
Suppliers and Packaging for NDA: 022181
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KUVAN sapropterin dihydrochloride TABLET;ORAL 022181 NDA BioMarin Pharmaceutical Inc. 68135-300 68135-300-02 120 TABLET in 1 BOTTLE (68135-300-02)
Paragraph IV (Patent) Challenges for 022181
Tradename Dosage Ingredient NDA Submissiondate
KUVAN TABLET;ORAL sapropterin dihydrochloride 022181 2014-06-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 13, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 16, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

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