DrugPatentWatch Database Preview
KUVAN Drug Profile
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 eleven patents protecting this drug and three Paragraph IV challenges.
This drug has eighty-seven 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. One supplier is 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 January 24th, 2020.
Summary for KUVAN
| International Patents: | 87 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 68 |
| Patent Applications: | 199 |
| Drug Prices: | Drug price information for KUVAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for KUVAN |
| 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 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | 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 | ||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | RX | Yes | No | 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 |
|---|---|---|
| Canada | 2545584 | Start Trial |
| South Korea | 20160064248 | Start Trial |
| Canada | 2678124 | Start Trial |
| Japan | 2007511536 | Start Trial |
| Australia | 2004291149 | Start Trial |
| Peru | 20061294 | Start Trial |
| South Korea | 20160065998 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
