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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Argus Health
Cerilliant
McKesson
AstraZeneca
Novartis
Baxter
Julphar
Cipla

Generated: October 21, 2017

DrugPatentWatch Database Preview

ABILIFY Drug Profile

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What is the patent landscape for Abilify, and what generic Abilify alternatives are available?

Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in five NDAs. There are twenty-three patents protecting this drug and three Paragraph IV challenges.

This drug has four hundred and twenty-four patent family members in forty-nine countries and four supplementary protection certificates in three countries.

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

Summary for Tradename: ABILIFY

US Patents:15
Applicants:2
NDAs:5
Suppliers / Packagers: see list14
Bulk Api Vendors: see list94
Clinical Trials: see list59
Patent Applications: see list3,368
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ABILIFY at DailyMed

Pharmacology for Tradename: ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo► Subscribe► Subscribe ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo► Subscribe► SubscribeY► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-003Sep 29, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka Pharm Co Ltd
ABILIFY MAINTENA KIT
aripiprazole
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 2006DISCNNoNo► Subscribe► SubscribeY► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ABILIFY

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
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 2006► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ABILIFY

Drugname Dosage Strength RLD Submissiondate
aripiprazoleOral Solution1 mg/mLAbilify12/20/2007
aripiprazoleTablets2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006
aripiprazoleOrally Disintegrating Tablets10 mg, 15 mg, 20 mg and 30 mgAbilify11/15/2006

Non-Orange Book Patents for Tradename: ABILIFY

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
8,680,105Method of treating down's syndrome► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,030,3125-HT1A receptor subtype agonist► Subscribe
9,387,2075-HT1A receptor subtype agonist► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,399,469Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,999,952Aripiprazole complex formulation and method► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,993,761Low 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
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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 Tradename: ABILIFY

Country Document Number Estimated Expiration
Denmark1927356► Subscribe
Lithuania1925308► Subscribe
Hong Kong1101550► Subscribe
China101434573► Subscribe
Lithuania4896► Subscribe
EcuadorSP055885► Subscribe
TaiwanI324074► Subscribe
Hong Kong1203060► Subscribe
Peru01242009► Subscribe
Iceland7701► 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.
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Supplementary Protection Certificates for Tradename: ABILIFY

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
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Accenture
Mallinckrodt
Novartis
Chubb
Covington
Deloitte
US Department of Justice
McKinsey

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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