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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, Macleods Pharms Ltd, Otsuka, Torrent Pharms Ltd, Accord Hlthcare, Hetero Labs Ltd V, Otsuka Pharm Co Ltd, Silarx Pharms Inc, Ajanta Pharma Ltd, Stason Pharms, Apotex Inc, Sciegen Pharms Inc, and Alkermes Inc, and is included in twenty-four NDAs. There are twenty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has four hundred and forty-one patent family members in fifty countries.

There are forty-three drug master file entries for aripiprazole. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: aripiprazole

Tradenames:4
Patents:29
Applicants:16
NDAs:24
Drug Master File Entries: see list43
Suppliers / Packagers: see list40
Bulk Api Vendors: see list94
Clinical Trials: see list77
Patent Applications: see list3,065
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:aripiprazole at DailyMed

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 2004DISCNYesNo6,977,257*PED► subscribeY► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002RXYesNo8,017,615*PED► subscribeY► subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo8,338,427► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 20135,006,528*PED► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 20065,006,528*PED► subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 20025,006,528*PED► subscribe
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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
8,999,952Aripiprazole complex formulation and method► subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► subscribe
8,722,680Method of treating neurodegenerative diseases► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
Hungary230456► subscribe
New Zealand540060► subscribe
Russian Federation2005140285► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/039United Kingdom► subscribePRODUCT 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
427Luxembourg► subscribePRODUCT NAME: ARIPIPRAZOLE
/2014Austria► subscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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