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Generated: November 14, 2018

DrugPatentWatch Database Preview

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
Tradename:KUVAN
Applicant:Biomarin Pharm
Ingredient:sapropterin dihydrochloride
Patents:10
Generic Entry Opportunity Date for 022181
Generic Entry Date for 022181*:
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Constraining patent/regulatory exclusivity:
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Dosage:
TABLET;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.

Pharmacology for NDA: 022181
Mechanism of ActionPhenylalanine Hydroxylase Activators
Breast Cancer Resistance Protein Inhibitors
P-Glycoprotein Inhibitors
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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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.

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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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