Details for New Drug Application (NDA): 218390
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NDA 218390 describes INGREZZA SPRINKLE, which is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier. There are twenty-two patents protecting this drug. Additional details are available on the INGREZZA SPRINKLE profile page.
The generic ingredient in INGREZZA SPRINKLE is valbenazine tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
The generic ingredient in INGREZZA SPRINKLE is valbenazine tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
Summary for 218390
| Tradename: | INGREZZA SPRINKLE |
| Applicant: | Neurocrine |
| Ingredient: | valbenazine tosylate |
| Patents: | 22 |
Pharmacology for NDA: 218390
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 218390
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390 | NDA | Neurocrine Biosciences, Inc. | 70370-4040 | 70370-4040-1 | 30 CAPSULE in 1 BOTTLE (70370-4040-1) |
| INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390 | NDA | Neurocrine Biosciences, Inc. | 70370-4060 | 70370-4060-1 | 30 CAPSULE in 1 BOTTLE (70370-4060-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 30, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 18, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | A METHOD OF TREATING HUNTINGTON'S CHOREA | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF TARDIVE DYSKINESIA | ||||||||
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