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.
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: | 2 |
| 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
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 | ||
| >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 |
|---|---|---|---|
| Canada | 2545584 | METHODES ET COMPOSITIONS POUR LE TRAITEMENT DES TROUBLES DU METABOLISME (TREATMENT OF PHENYLKETONURIAS WITH BH4) | ⤷ Sign Up |
| Japan | 2007511536 | ⤷ Sign Up | |
| Japan | 2014012740 | STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN | ⤷ Sign Up |
| European Patent Office | 4029519 | TÉTRAHYDROBIOPTÉRINE POUR LE TRAITEMENT DES CONDITIONS ASSOCIÉES AUX NIVEAUX ÉLEVÉS DE PHÉNYLALANINE (TETRAHYDROBIOPTERIN FOR TREATING CONDITIONS ASSOCIATED WITH ELEVATED PHENYLALANINE LEVELS) | ⤷ 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.
ISSN: 2162-2639
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