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Details for New Drug Application (NDA): 205065
NDA 205065 describes KUVAN, which is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KUVAN profile page.
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.
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 205065
| Tradename: | KUVAN |
| Applicant: | Biomarin Pharm |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 6 |
Generic Entry Opportunity Date for 205065
Generic Entry Date for 205065*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 205065
Suppliers and Packaging for NDA: 205065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065 | NDA | BioMarin Pharmaceutical Inc. | 68135-301 | 68135-301-22 | 30 PACKET in 1 CARTON (68135-301-22) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11) |
| KUVAN | sapropterin dihydrochloride | POWDER;ORAL | 205065 | NDA | BioMarin Pharmaceutical Inc. | 68135-482 | 68135-482-11 | 30 PACKET in 1 CARTON (68135-482-11) > 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
| Approval Date: | Dec 19, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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