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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-five 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.

Summary for KUVAN

International Patents:	85
US Patents:	11
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	69
Drug Prices:	Drug price information for KUVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KUVAN
Prior Art and Litigation Support	Order Prior Art and Litigation support for KUVAN
DailyMed Link:	KUVAN at DailyMed

Generic Entry Opportunity Date for KUVAN

NDA:

205065

Dosage:

POWDER;ORAL

NDA:

022181

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 KUVAN

Drug Class	Phenylalanine Hydroxylase Activator
Mechanism of Action	Phenylalanine Hydroxylase Activators Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors

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		RX	Yes	Yes
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013		RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes					Y

Paragraph IV (Patent) Challenges for KUVAN

Drugname	Dosage	Strength	RLD	Date
	Powder for Oral Solution	500 mg/packet
	Powder for Oral Solution	100 mg per packet
	Tablets	100 mg

International Patents for KUVAN

Country	Patent Number	Estimated Expiration
Brazil	PI0809470
Japan	2007536210
Portugal	2139485
European Patent Office	1708690
Japan	2014012740
China	101132776