Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Moodys
Mallinckrodt
Dow
McKinsey

Last Updated: May 30, 2023

KUVAN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of metabolic disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dry blend formulation of tetrahydrobiopterin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of metabolic disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of administering tetrahydrobiopterin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride TABLET;ORAL 022181-001 Dec 13, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biomarin Pharm KUVAN sapropterin dihydrochloride POWDER;ORAL 205065-002 Oct 27, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

Patent: 04291149
Estimated Expiration: ⤷  Try a Trial

Patent: 05306686
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0416566
Estimated Expiration: ⤷  Try a Trial

Patent: 0517088
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 45584
Estimated Expiration: ⤷  Try a Trial

Patent: 81814
Estimated Expiration: ⤷  Try a Trial

China

Patent: 05863
Estimated Expiration: ⤷  Try a Trial

Patent: 1132776
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18171
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 08690
Estimated Expiration: ⤷  Try a Trial

Patent: 38566
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 08690
Estimated Expiration: ⤷  Try a Trial

Patent: 45952
Estimated Expiration: ⤷  Try a Trial

Patent: 36379
Estimated Expiration: ⤷  Try a Trial

Patent: 38566
Estimated Expiration: ⤷  Try a Trial

Patent: 77999
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 94875
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 29533
Estimated Expiration: ⤷  Try a Trial

Patent: 58126
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5529
Estimated Expiration: ⤷  Try a Trial

Patent: 2161
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 07511536
Estimated Expiration: ⤷  Try a Trial

Patent: 08520574
Estimated Expiration: ⤷  Try a Trial

Patent: 12207029
Estimated Expiration: ⤷  Try a Trial

Patent: 14012740
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2120
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06005451
Estimated Expiration: ⤷  Try a Trial

Patent: 07005039
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 061294
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 08690
Estimated Expiration: ⤷  Try a Trial

Patent: 38566
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 08690
Estimated Expiration: ⤷  Try a Trial

Patent: 38566
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 38566
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 070005550
Estimated Expiration: ⤷  Try a Trial

Patent: 070084270
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 96827
Estimated Expiration: ⤷  Try a Trial

Patent: 05305
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 0624120
Estimated Expiration: ⤷  Try a Trial

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 comprim√© stable (Stable tablet formulation) ⤷  Try a Trial
Canada 2678165 FORMES CRISTALLINES DE DIHYDROCHLORURE DE (6R)-L-ERYTHRO-TETRAHYDROBIOPTERINE (CRYSTALLINE FORMS OF (6R)-L-ERYTHRO-TETRAHYDROBIOPTERIN DIHYDROCHLORIDE) ⤷  Try a Trial
China 101969953 Pterin analog for treating bh4 responsive condition ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
McKesson
Dow
Harvard Business School
Merck

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.