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Last Updated: May 21, 2022

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 two suppliers. There are ten 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. Four suppliers are 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
Pharmacology for NDA: 205065
Mechanism of ActionBreast Cancer Resistance Protein Inhibitors
P-Glycoprotein Inhibitors
Phenylalanine Hydroxylase Activators
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:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:May 17, 2025Product Flag?Substance Flag?Delist Request?Y

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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 verification 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.

 
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2022, www.DrugPatentWatch.com.

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