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Generated: November 21, 2018

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Details for New Drug Application (NDA): 205422

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NDA 205422 describes REXULTI, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the REXULTI profile page.

The generic ingredient in REXULTI is brexpiprazole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 205422
Tradename:REXULTI
Applicant:Otsuka Pharm Co Ltd
Ingredient:brexpiprazole
Patents:4
Generic Entry Opportunity Date for 205422
Generic Entry Date for 205422*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 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 30 TABLET in 1 BOTTLE (59148-035-13)
REXULTI brexpiprazole TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-036 59148-036-13 30 TABLET in 1 BOTTLE (59148-036-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 10, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 23, 2019
Regulatory Exclusivity Use:UPDATES TO THE PRODUCT INFORMATION REGARDING MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS BASED UPON THE RESULTS FROM STUDY 331-10-232
Patent:➤ Try a Free TrialPatent Expiration:Feb 23, 2027Product Flag?Substance Flag?YDelist Request?

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