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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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.
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
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. 70370-1040 70370-1040-2 90 CAPSULE in 1 BOTTLE (70370-1040-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 40MG BASE
Approval Date:Apr 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 11, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TARDIVE DYSKINESIA
Patent:  Start TrialPatent Expiration:Oct 6, 2029Product Flag?YSubstance Flag?YDelist Request?

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