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US Army
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Johnson and Johnson
Deloitte
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Generated: October 17, 2017

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Aripiprazole - Generic Drug Details

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What are the generic drug sources for aripiprazole and what is the scope of aripiprazole freedom to operate?

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, Santos Biotech, Apotex Inc, Orchid Hlthcare, Sciegen Pharms Inc, and Alkermes Inc, and is included in twenty-five 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.

Aripiprazole has four hundred and ninety-four patent family members in fifty-one countries and nine supplementary protection certificates in eight countries.

There are forty-four 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

US Patents:29
Tradenames:4
Applicants:17
NDAs:25
Drug Master File Entries: see list44
Suppliers / Packagers: see list40
Bulk Api Vendors: see list94
Clinical Trials: see list317
Patent Applications: see list5,570
Therapeutic Class: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. Strength Dosage Form
u► Subscribe10MGTABLET, ORALLY DISINTEGRATING; ORAL
u► Subscribe30MGTABLET; ORALLY DISINTEGRATING
u► Subscribe20MGTABLET, ORALLY DISINTEGRATING; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL204838-001Jun 17, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Alkermes Inc
ARISTADA
aripiprazole lauroxil
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207533-003Oct 5, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Accord Hlthcare
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL206251-005Dec 7, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Aurobindo Pharma Ltd
ARIPIPRAZOLE
aripiprazole
TABLET;ORAL203908-002Oct 8, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► Subscribe► 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
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-004Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 2004► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006► Subscribe► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-004Sep 29, 2014► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006► Subscribe► 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
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,030,3125-HT1A receptor subtype agonist► Subscribe
9,387,2075-HT1A receptor subtype agonist► Subscribe
9,694,009Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,703,773Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,604,041Method of treating panic disorder► 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.

Export unavailable in trial.
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International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
China101434573► Subscribe
Russian Federation2005107471► Subscribe
Canada2688860► Subscribe
Denmark1927357► Subscribe
Peru09232004► Subscribe
Argentina040887► Subscribe
Taiwan200507846► Subscribe
Japan2006501240► Subscribe
Czech Republic306181► Subscribe
Denmark1660037► 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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573/01Switzerland► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
/2014Austria► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
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
9 5013-2014Slovakia► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
2014020Lithuania► SubscribePRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Express Scripts
Fuji
AstraZeneca
Medtronic
Cerilliant
Boehringer Ingelheim
Deloitte
Chubb

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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