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Serving leading biopharmaceutical companies globally:

Healthtrust
Julphar
Cantor Fitzgerald
US Army
Cipla
Farmers Insurance
Merck
Daiichi Sankyo
Covington
Chinese Patent Office

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021866

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NDA 021866 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. It is available from thirteen suppliers. There are twenty-three 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 021866
Tradename:ABILIFY
Applicant:Otsuka
Ingredient:aripiprazole
Patents:2
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021866
Medical Subject Heading (MeSH) Categories for 021866
Suppliers and Packaging for NDA: 021866
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866 NDA Otsuka America Pharmaceutical, Inc. 59148-016 59148-016-65 1.3 mL in 1 VIAL (59148-016-65)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULARStrength9.75MG/1.3ML (7.5MG/ML)
Approval Date:Sep 20, 2006TE:RLD:No
Regulatory Exclusivity Expiration:Jun 9, 2017
Regulatory Exclusivity Use:LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
Regulatory Exclusivity Expiration:Dec 12, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Regulatory Exclusivity Expiration:Dec 12, 2017
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)

Expired US Patents for NDA 021866

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Covington
Cipla
Chinese Patent Office
Deloitte
Novartis
Argus Health
Citi

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