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Last Updated: July 13, 2024

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 two NDAs. It is available from one supplier. There are twenty-two 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.
Summary for 209241
Tradename:INGREZZA
Applicant:Neurocrine
Ingredient:valbenazine tosylate
Patents:22
Pharmacology for NDA: 209241
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. 70370-1060 70370-1060-1 30 CAPSULE in 1 BOTTLE (70370-1060-1)
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:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Apr 11, 2017TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 18, 2030
Regulatory Exclusivity Use:FOR TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Regulatory Exclusivity Expiration:Aug 18, 2026
Regulatory Exclusivity Use:TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE
Patent:⤷  Sign UpPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING HUNTINGTON'S CHOREA

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