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Generated: November 17, 2018

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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
Generic Entry Opportunity Date for 205065
Generic Entry Date for 205065*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;ORAL

*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: 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 68135-301-22 30 PACKET in 1 CARTON (68135-301-22) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11)
KUVAN sapropterin dihydrochloride POWDER;ORAL 205065 NDA BioMarin Pharmaceutical Inc. 68135-482 68135-482-11 30 PACKET in 1 CARTON (68135-482-11) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)

Profile for product number 001

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

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