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Details for New Drug Application (NDA): 209241
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NDA 209241 describes INGREZZA, which is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the INGREZZA profile page.
The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
Summary for 209241
| Tradename: | INGREZZA |
| Applicant: | Neurocrine |
| Ingredient: | valbenazine tosylate |
| Patents: | 3 |
Generic Entry Opportunity Date for 209241
Generic Entry Date for 209241*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 209241
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 209241
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1040 | 70370-1040-1 | 30 CAPSULE in 1 BOTTLE (70370-1040-1) |
| INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241 | NDA | Neurocrine Biosciences, Inc. | 70370-1080 | 70370-1080-1 | 30 CAPSULE in 1 BOTTLE (70370-1080-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Apr 11, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 11, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF TARDIVE DYSKINESIA | ||||||||
| Patent: | Start Trial | Patent Expiration: | Oct 6, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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