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Generated: January 22, 2019

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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
Generic Entry Opportunity Date for 022181
Generic Entry Date for 022181*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 13, 2007TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:May 16, 2026Product 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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