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. 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 ENDO OPERATIONS on May 10th, 2019.
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Summary for KUVAN
| International Patents: | 117 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Patent Applications: | 169 |
| 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 |
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
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Methods and compositions for the treatment of metabolic disorders
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Patent Expiration: ⤷ Sign Up
Dry blend formulation of tetrahydrobiopterin
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Patent Expiration: ⤷ Sign Up
Methods and compositions for the treatment of metabolic disorders
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Patent Expiration: ⤷ Sign Up
Methods of administering tetrahydrobiopterin
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| 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
See the table below for patents covering KUVAN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20160065998 | 테트라하이드로바이오프테린 투여 방법, 관련 조성물 및 측정 방법 (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING) | ⤷ Sign Up |
| Japan | 2014012740 | STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN | ⤷ Sign Up |
| Mexico | 2009010977 | METODOS DE ADMINISTRACION DE TETRAHIDROBIOPTERINA, COMPOSICIONES ASOCIADAS Y METODOS DE MEDICION. (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING.) | ⤷ Sign Up |
| Japan | 2010523708 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2009088530 | ⤷ Sign Up | |
| Denmark | 3138566 | ⤷ 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.
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