KUVAN Drug Patent Profile

Which patents cover Kuvan, and what generic alternatives are available?

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

This drug has one hundred and fourteen patent family members in twenty-six countries.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kuvan

A generic version of KUVAN was approved as sapropterin dihydrochloride by PAR PHARM INC on May 10^th, 2019.

Summary for KUVAN

International Patents:	114
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	236
Drug Prices:	Drug price information for KUVAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KUVAN
What excipients (inactive ingredients) are in KUVAN?	KUVAN excipients list
DailyMed Link:	KUVAN at DailyMed

See drug prices for KUVAN

Pharmacology for KUVAN

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

Anatomical Therapeutic Chemical (ATC) Classes for KUVAN

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for KUVAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	500 mg per packet	205065	1	2017-02-23
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	100 mg per packet	205065	1	2015-11-09
KUVAN	Tablets	sapropterin dihydrochloride	100 mg	022181	1	2014-06-05

US Patents and Regulatory Information for KUVAN

KUVAN is protected by six US patents.

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

International Patents for KUVAN

When does loss-of-exclusivity occur for KUVAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Peru

Poland

Portugal

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KUVAN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2436379	Formule de comprimé stable (Stable tablet formulation)
Canada	2678165	FORMES CRISTALLINES DE DIHYDROCHLORURE DE (6R)-L-ERYTHRO-TETRAHYDROBIOPTERINE (CRYSTALLINE FORMS OF (6R)-L-ERYTHRO-TETRAHYDROBIOPTERIN DIHYDROCHLORIDE)
China	101969953	Pterin analog for treating bh4 responsive condition