DrugPatentWatch Database Preview
KUVAN Drug Profile
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-six 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.
Summary for KUVAN
| International Patents: | 86 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 69 |
| Patent Applications: | 195 |
| 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 |
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 | See Pricing | See Pricing | See Pricing | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181-001 | Dec 13, 2007 | RX | Yes | Yes | See Pricing | See Pricing | Y | See Pricing | |||
| Biomarin Pharm | KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065-002 | Oct 27, 2015 | AB | RX | Yes | No | See Pricing | See Pricing | See Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Paragraph IV (Patent) Challenges for KUVAN
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Powder for Oral Solution | 500 mg/packet | ➤ Subscribe | See Pricing |
| ➤ Subscribe | Powder for Oral Solution | 100 mg per packet | ➤ Subscribe | See Pricing |
| ➤ Subscribe | Tablets | 100 mg | ➤ Subscribe | See Pricing |
International Patents for KUVAN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2008128049 | See Pricing |
| China | 1905863 | See Pricing |
| Denmark | 2139485 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
