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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Daiichi Sankyo
Boehringer Ingelheim
McKesson
Johnson and Johnson
Baxter
McKinsey
Queensland Health
Federal Trade Commission

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021713

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NDA 021713 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from ten suppliers. There are forty-nine patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.

The generic ingredient in ABILIFY is aripiprazole. There are forty-five drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021713
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:5
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021713
Medical Subject Heading (MeSH) Categories for 021713
Suppliers and Packaging for NDA: 021713
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole SOLUTION;ORAL 021713 NDA Otsuka America Pharmaceutical, Inc. 59148-013 N 59148-013-15

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 10, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
Patent:➤ Sign UpPatent Expiration:Oct 24, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jan 28, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Expired US Patents for NDA 021713

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
McKesson
Boehringer Ingelheim
Moodys
Cerilliant
Deloitte
US Department of Justice
Covington
Fuji

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