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Last Updated: July 13, 2024

KUVAN Drug Patent Profile


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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 seventeen 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. Six suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

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Drug patent expirations by year for KUVAN
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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

Methods and compositions for the treatment of metabolic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods and compositions for the treatment of metabolic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dry blend formulation of tetrahydrobiopterin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods and compositions for the treatment of metabolic disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of administering tetrahydrobiopterin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

Patent: 2238
Patent: FORMULACION DE TABLETAS ESTABLES
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 05306686
Patent: Stable tablet formulation of tetrahydrobiopterin
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0517088
Patent: formulação de comprimido estável
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 81814
Patent: FORMULE STABLE DE COMPRIMES (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1132776
Patent: Stable tablet formulation of tetrahydrobiopterin
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 45952
Patent: FORMULE STABLE DE COMPRIMES DE TETRAHYDROBIOPTERINE (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN)
Estimated Expiration: ⤷  Sign Up

Patent: 36379
Patent: Formule de comprimé stable (Stable tablet formulation)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2161
Patent: STABLE FORMULATION COMPRISING A CRYSTALLINE POLYMORPH OF (6R)-L-ERYTHRO-TETRAHYDROBIOPTERIN DIHYDROCHLORIDE
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 08520574
Estimated Expiration: ⤷  Sign Up

Patent: 14012740
Patent: STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2120
Patent: STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07005039
Patent: FORMULACION DE TABLETA ESTABLE. (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN.)
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 061294
Patent: FORMULACION DE TABLETA ESTABLE QUE CONTIENE POLIMORFO B DE (6R)-L-ERITRO-TETRA HIDROBIOPTERINA
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 070084270
Patent: STABLE TABLET FORMULATION
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 0624120
Patent: Stable tablet formulation
Estimated Expiration: ⤷  Sign Up

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
Japan 2012207029 METHOD AND COMPOSITION FOR TREATMENT OF METABOLIC DISORDER ⤷  Sign Up
Portugal 2545939 ⤷  Sign Up
Croatia P20220188 ⤷  Sign Up
Cyprus 1118171 ⤷  Sign Up
South Korea 20160064248 테트라하이드로바이오프테린 투여 방법, 관련 조성물 및 측정 방법 (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING) ⤷  Sign Up
Canada 2678124 FORMES CRISTALLINES DE DIHYDROCHLORURE DE (6R)-L-ERYTHRO-TETRAHYDROBIOPTERINE (CRYSTALLINE FORMS OF (6R)-L-ERYTHRO-TETRAHYDROBIOPTERIN DIHYDROCHLORIDE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.