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Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202971

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NDA 202971 describes ABILIFY MAINTENA KIT, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ABILIFY MAINTENA KIT profile page.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-four drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

Summary for NDA: 202971

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:9
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202971

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 NDA Otsuka America Pharmaceutical, Inc. 59148-018 59148-018-71 1 KIT in 1 CARTON (59148-018-71) * 5 mL in 1 VIAL, SINGLE-USE * 1.5 mL in 1 VIAL, SINGLE-USE
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971 NDA Otsuka America Pharmaceutical, Inc. 59148-019 59148-019-71 1 KIT in 1 CARTON (59148-019-71) * 5 mL in 1 VIAL, SINGLE-USE * 1.9 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength300MG/VIAL
Approval Date:Feb 28, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Dec 5, 2017
Regulatory Exclusivity Use:ADDITION OF THE RESULTS OF A CONTROLLED CLINICAL STUDY TREATING ADULT PATIENTS WITH SCHIZOPHRENIA EXPERIENCING AN ACUTE RELAPSE
Patent:► SubscribePatent Expiration:Oct 19, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202971

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-002Feb 28, 2013► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Moodys
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Federal Trade Commission
McKinsey
US Army
Express Scripts
Mallinckrodt
Farmers Insurance
Johnson and Johnson
Dow

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