Kuvan Drug Patent Profile
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Which patents cover Kuvan, and when can generic versions of Kuvan launch?
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 PAR PHARM INC on May 10th, 2019.
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: | 194 |
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: ⤷ 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 | ||
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 | 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: 05306686
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0517088
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 81814
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1132776
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 45952
Estimated Expiration: ⤷ Try a Trial
Patent: 36379
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2161
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 08520574
Estimated Expiration: ⤷ Try a Trial
Patent: 14012740
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 2120
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07005039
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 061294
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 070084270
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 | 3461503 | PROCÉDÉS D'ADMINISTRATION DE LA TÉTRAHYDROBIOPTÉRINE, COMPOSITIONS ASSOCIÉES ET PROCÉDÉS DE MESURE (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING) | ⤷ Try a Trial |
Portugal | 2545939 | ⤷ Try a Trial | |
Russian Federation | 2470642 | АНАЛОГИ ПТЕРИНА ДЛЯ ЛЕЧЕНИЯ СОСТОЯНИЯ, ЧУВСТВИТЕЛЬНОГО К ВН4 (PTERIN ANALOGUES FOR TREATING BH4 SENSITIVE CONDITION) | ⤷ Try a Trial |
Canada | 2581814 | FORMULE STABLE DE COMPRIMES (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN) | ⤷ Try a Trial |
Peru | 20061294 | FORMULACION DE TABLETA ESTABLE QUE CONTIENE POLIMORFO B DE (6R)-L-ERITRO-TETRA HIDROBIOPTERINA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |