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Last Updated: January 24, 2020

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KUVAN Drug Profile

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Which patents cover Kuvan, and when can generic versions of Kuvan launch?

Kuvan is a drug marketed by Biomarin Pharm and is included in two NDAs. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-seven patent family members in twenty-four countries.

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.

Drug patent expirations by year for KUVAN
Drug Prices for KUVAN

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Recent Litigation for KUVAN

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District Court Litigation
Case NameDate
BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.2015-03-06

See all KUVAN litigation

Paragraph IV (Patent) Challenges for KUVAN
Tradename Dosage Ingredient NDA Submissiondate
KUVAN POWDER;ORAL sapropterin dihydrochloride 205065 2017-02-23
KUVAN POWDER;ORAL sapropterin dihydrochloride 205065 2015-11-09
KUVAN TABLET;ORAL sapropterin dihydrochloride 022181 2014-06-05

US Patents and Regulatory Information for KUVAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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