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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Kuvan
A generic version of KUVAN was approved as sapropterin dihydrochloride by PAR PHARM INC on May 10th, 2019.
Summary for KUVAN
| International Patents: | 106 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 85 |
| Patent Applications: | 1,799 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for KUVAN
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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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.
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