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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance

Generated: December 14, 2017

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 three patents protecting this drug. Additional details are available on the REXULTI profile page.

The generic ingredient in REXULTI is brexpiprazole. Two suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.

Summary for 205422


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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 23, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Jul 10, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Feb 23, 2027Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Farmers Insurance
Harvard Business School

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