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Details for New Drug Application (NDA): 022181
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NDA 022181 describes KUVAN, which is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from two suppliers. 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. Four suppliers are 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. Four suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
Summary for 022181
| Tradename: | KUVAN |
| Applicant: | Biomarin Pharm |
| Ingredient: | sapropterin dihydrochloride |
| Patents: | 10 |
Suppliers and Packaging for NDA: 022181
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181 | NDA | Dr. Reddys Laboratories Inc. | 43598-749 | 43598-749-04 | 1 BOTTLE in 1 CARTON (43598-749-04) > 120 TABLET in 1 BOTTLE |
| KUVAN | sapropterin dihydrochloride | TABLET;ORAL | 022181 | NDA | BioMarin Pharmaceutical Inc. | 68135-300 | 68135-300-02 | 120 TABLET in 1 BOTTLE (68135-300-02) |
Paragraph IV (Patent) Challenges for 022181
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| KUVAN | TABLET;ORAL | sapropterin dihydrochloride | 022181 | 2014-06-05 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 13, 2007 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try it Free | Patent Expiration: | May 16, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try it Free | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Try it Free | Patent Expiration: | May 17, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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