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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Questions you can ask:
- What is the 5 year forecast for KUVAN?
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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: | 182 |
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.
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 | 8,067,416*PED | ⤷ Try for Free | ⤷ Try for Free | |||
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | AB | RX | Yes | Yes | 8,067,416*PED | ⤷ Try for Free | ⤷ Try for Free | |||
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | AB | RX | Yes | No | 7,612,073*PED | ⤷ Try for Free | ⤷ Try for Free | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for KUVAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | 7,727,987*PED | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | RE43797*PED | ⤷ Try for Free |
Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-001 | Dec 19, 2013 | 8,067,416*PED | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KUVAN
See the table below for patents covering KUVAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101721198 | ⤷ Try for Free | |
Portugal | 1708690 | ⤷ Try for Free | |
European Patent Office | 1845952 | FORMULE STABLE DE COMPRIMES DE TETRAHYDROBIOPTERINE (STABLE TABLET FORMULATION OF TETRAHYDROBIOPTERIN) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for KUVAN (Sapropterin Hydrochloride)
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