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Last Updated: September 29, 2023

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 twenty 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:20
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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. 70370-1060 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:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TARDIVE DYSKINESIA
Patent:⤷  Try a TrialPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TARDIVE DYSKINESIA
Patent:⤷  Try a TrialPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF TARDIVE DYSKINESIA

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