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KUVAN Drug 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 eleven patents protecting this drug and three Paragraph IV challenges.
This drug has eighty-nine patent family members in twenty-four countries.
The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
US ANDA 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: | 89 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 79 |
| Patent Applications: | 1,597 |
| 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 | NDA | Submissiondate |
|---|---|---|---|---|
| KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2017-02-23 |
| KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2015-11-09 |
| KUVAN | TABLET;ORAL | sapropterin dihydrochloride | 022181 | 2014-06-05 |
US Patents and Regulatory Information for KUVAN
| 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 | Start Trial | Start Trial | Start Trial | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-001 | Dec 19, 2013 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2007005039 | Start Trial |
| Portugal | 1708690 | Start Trial |
| Japan | 2011508775 | Start Trial |
| Denmark | 1708690 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
