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Last Updated: July 19, 2024

Details for New Drug Application (NDA): 205422


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NDA 205422 describes REXULTI, which is a drug marketed by Otsuka and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the REXULTI profile page.

The generic ingredient in REXULTI is brexpiprazole. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 205422
Tradename:REXULTI
Applicant:Otsuka
Ingredient:brexpiprazole
Patents:6
Pharmacology for NDA: 205422
Suppliers and Packaging for NDA: 205422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REXULTI brexpiprazole TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-035 59148-035-13 1 BOTTLE in 1 CARTON (59148-035-13) / 30 TABLET in 1 BOTTLE
REXULTI brexpiprazole TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-036 59148-036-07 1 BLISTER PACK in 1 CARTON (59148-036-07) / 7 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 10, 2015TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 27, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 10, 2026
Regulatory Exclusivity Use:TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE
Patent:⤷  Sign UpPatent Expiration:Oct 12, 2032Product Flag?YSubstance Flag?Delist Request?

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