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Generated: November 14, 2018

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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-eight 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 202971
Tradename:ABILIFY MAINTENA KIT
Applicant:Otsuka Pharm Co Ltd
Ingredient:aripiprazole
Patents:9
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202971
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) * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE

Profile 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:NEW INDICATION OF MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER IN ADULTS
Patent:➤ Sign UpPatent Expiration:Oct 19, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 19, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA

Expired US 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;INTRAMUSCULAR 202971-001 Feb 28, 2013 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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