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Aripiprazole - Generic Drug Details

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Aripiprazole is the generic ingredient in four branded drugs marketed by Alembic Pharms Ltd, Amneal Pharms, Teva Pharms Usa, Aurobindo Pharma Ltd, Otsuka, Torrent Pharms Ltd, Hetero Labs Ltd V, Otsuka Pharm Co Ltd, Silarx Pharms Inc, Apotex Inc, and Alkermes Inc, and is included in eighteen NDAs. There are twenty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and sixty-one patent family members in forty-three countries.

There are forty-one drug master file entries for aripiprazole. Thirty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: aripiprazole

Tradenames:4
Patents:24
Applicants:11
NDAs:18
Drug Master File Entries: see list41
Suppliers / Packaging: see list32
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: aripiprazole

Tentative approvals for ARIPIPRAZOLE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL10MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL15MG
<disabled><disabled>TABLET, ORALLY DISINTEGRATING; ORAL20MG

Clinical Trials for: aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNNo8,580,796*PED<disabled>Y<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002RXNo8,580,796*PED<disabled>Y<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002RXYes7,053,092<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: aripiprazole

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 20065,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 20045,006,528*PED<disabled>
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 20065,006,528*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: aripiprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof<disabled in preview>
9,006,2485-HT.sub.1A receptor subtype agonist<disabled in preview>
8,030,3125-HT1A receptor subtype agonist<disabled in preview>
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International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
Iceland2878<disabled in preview>
Japan2007503460<disabled in preview>
China104306374<disabled in preview>
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Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/039United Kingdom<disabled>PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
00669Netherlands<disabled>PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
427Luxembourg<disabled>PRODUCT NAME: ARIPIPRAZOLE
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