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Last Updated: May 27, 2022

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 six patent family members in twenty-five countries.

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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of metabolic disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dry blend formulation of tetrahydrobiopterin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of metabolic disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA

Methods of administering tetrahydrobiopterin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-001 Dec 19, 2013 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04291149
Estimated Expiration: See Plans and Pricing

Patent: 05306686
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0416566
Estimated Expiration: See Plans and Pricing

Patent: 0517088
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45584
Estimated Expiration: See Plans and Pricing

Patent: 81814
Estimated Expiration: See Plans and Pricing

China

Patent: 05863
Estimated Expiration: See Plans and Pricing

Patent: 1132776
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18171
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 08690
Estimated Expiration: See Plans and Pricing

Patent: 38566
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 08690
Estimated Expiration: See Plans and Pricing

Patent: 45952
Estimated Expiration: See Plans and Pricing

Patent: 36379
Estimated Expiration: See Plans and Pricing

Patent: 38566
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 94875
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29533
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5529
Estimated Expiration: See Plans and Pricing

Patent: 2161
Estimated Expiration: See Plans and Pricing

Japan

Patent: 07511536
Estimated Expiration: See Plans and Pricing

Patent: 08520574
Estimated Expiration: See Plans and Pricing

Patent: 12207029
Estimated Expiration: See Plans and Pricing

Patent: 14012740
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2120
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06005451
Estimated Expiration: See Plans and Pricing

Patent: 07005039
Estimated Expiration: See Plans and Pricing

Peru

Patent: 061294
Estimated Expiration: See Plans and Pricing

Poland

Patent: 08690
Estimated Expiration: See Plans and Pricing

Patent: 38566
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 08690
Estimated Expiration: See Plans and Pricing

Patent: 38566
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 070005550
Estimated Expiration: See Plans and Pricing

Patent: 070084270
Estimated Expiration: See Plans and Pricing

Spain

Patent: 96827
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0624120
Estimated Expiration: See Plans and Pricing

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 2007511536 See Plans and Pricing
Japan 2013163691 METHOD FOR ADMINISTERING TETRAHYDROBIOPTERIN, RELATED COMPOSITION, AND MEASUREMENT METHOD See Plans and Pricing
Australia 2008240259 Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring See Plans and Pricing
Japan 2012207029 METHOD AND COMPOSITION FOR TREATMENT OF METABOLIC DISORDER See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.