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Serving leading biopharmaceutical companies globally:

Moodys
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Baxter
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Cantor Fitzgerald
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Generated: November 19, 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 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.

Pharmacology for ABILIFY

Medical Subject Heading (MeSH) Categories for 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, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 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
TABLET;ORAL021436-006Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-005Nov 15, 2002► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
SOLUTION;ORAL021713-001Dec 10, 2004► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
INJECTABLE;INTRAMUSCULAR021866-001Sep 20, 2006► Subscribe► Subscribe
Otsuka
ABILIFY
aripiprazole
TABLET;ORAL021436-002Nov 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
9,006,2485-HT.sub.1A receptor subtype agonist► Subscribe
8,901,303Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,030,3125-HT1A receptor subtype agonist► Subscribe
8,901,130Low hygroscopic aripiprazole drug substance and processes for the preparation► Subscribe
8,623,874Method of treating neurodegenerative diseases► Subscribe
9,694,009Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders► Subscribe
8,993,761Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,703,772Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,399,469Low 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
Ukraine85235► Subscribe
Estonia200000497► Subscribe
New Zealand542985► Subscribe
Japan2006070045► Subscribe
Denmark1927357► Subscribe
TaiwanI332839► Subscribe
Russian Federation2003132426► Subscribe
Canada2688915► Subscribe
Serbia51903► Subscribe
Russian Federation2279429► 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
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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
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 leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Accenture
Argus Health
Deloitte
Federal Trade Commission
Harvard Business School
UBS
Chubb
McKesson

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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