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Generated: February 23, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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 two drug master file entries for this compound. Two suppliers are 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
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 N 59148-035-13
REXULTI brexpiprazole TABLET;ORAL 205422 NDA Otsuka America Pharmaceutical, Inc. 59148-036 N 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:➤ Sign UpPatent Expiration:Feb 23, 2027Product Flag?Substance Flag?YDelist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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