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Serving 500+ biopharmaceutical companies globally:

Colorcon
Farmers Insurance
QuintilesIMS
McKinsey
Julphar
McKesson
Queensland Health
Federal Trade Commission
Citi
Moodys

Generated: June 25, 2017

DrugPatentWatch Database Preview

ABILIFY Drug Profile

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Which patents cover Abilify, and when can generic versions of Abilify launch?

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 three hundred and eighty-nine patent family members in forty-nine 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

Patents:15
Applicants:2
NDAs:5
Suppliers / Packagers: see list14
Bulk Api Vendors: see list94
Clinical Trials: see list58
Patent Applications: see list3,165
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, 2002ABRXYesNo8,017,615*PED► SubscribeY► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 2002ABRXYesYes► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo9,359,302► SubscribeYY ► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo8,642,600*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 Patents for Tradename: ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-001Nov 15, 20024,734,416► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-006Nov 15, 20025,006,528*PED► Subscribe
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 20045,006,528*PED► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 20065,006,528*PED► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET, ORALLY DISINTEGRATING;ORAL021729-002Jun 7, 20065,006,528*PED► Subscribe
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Paragraph IV activity 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
8,623,874Method of treating neurodegenerative diseases► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,703,773Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► 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 Tradename: ABILIFY

Country Document Number Estimated Expiration
South Korea100530731► Subscribe
Portugal1927355► Subscribe
Malaysia140793► Subscribe
Australia752214► Subscribe
Russian Federation2389490► 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: ABILIFY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
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
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669Netherlands► 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 500+ biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Novartis
Cipla
US Army
Boehringer Ingelheim
Merck
Deloitte
Accenture
Express Scripts

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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