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Details for New Drug Application (NDA): 205065
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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 |
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) |
Paragraph IV (Patent) Challenges for 205065
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2017-02-23 |
| KUVAN | POWDER;ORAL | sapropterin dihydrochloride | 205065 | 2015-11-09 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 100MG/PACKET | ||||
| Approval Date: | Dec 19, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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