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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Cerilliant
Dow
AstraZeneca
Fuji
Queensland Health
Federal Trade Commission
Express Scripts
Mallinckrodt

Generated: April 22, 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 six NDAs. It is available from five suppliers. There are forty-eight 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-seven 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 N 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:Dec 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
Patent:➤ Sign UpPatent Expiration:Jan 21, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jan 21, 2025Product Flag?Substance Flag?Delist Request?Y

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 ➤ 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:

Cerilliant
Merck
Argus Health
Cantor Fitzgerald
Moodys
Julphar
Cipla
Medtronic
Healthtrust

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