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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Boehringer Ingelheim
Cerilliant
QuintilesIMS
UBS
Healthtrust
Express Scripts
Accenture
Farmers Insurance
Citi

Generated: January 21, 2018

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.

The generic ingredient in ABILIFY is aripiprazole. There are forty-five 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 ABILIFY
Drug patent expirations by year for ABILIFY
Pharmacology for ABILIFY
Medical Subject Heading (MeSH) Categories for ABILIFY

US Patents and Regulatory Information 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;ORAL 021436-006 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ABILIFY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ABILIFY
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe 12/20/2007
➤ Subscribe Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 11/15/2006
➤ Subscribe Orally Disintegrating Tablets 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 11/15/2006

Non-Orange Book US Patents for 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
8,680,105 Method of treating down's syndrome ➤ Subscribe
8,399,469 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,030,312 5-HT1A receptor subtype agonist ➤ Subscribe
9,387,207 5-HT1A receptor subtype agonist ➤ Subscribe
8,901,303 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,901,130 Low hygroscopic aripiprazole drug substance and processes for the preparation ➤ Subscribe
8,703,772 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,703,773 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,993,761 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,426,423 Method of treating Attention Deficit Hyper-Activity Disorder ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ABILIFY

Supplementary Protection Certificates for ABILIFY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00669 Netherlands ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669 Netherlands ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
427 Luxembourg ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLE
C/GB04/039 United Kingdom ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Novartis
AstraZeneca
Moodys
Fish and Richardson
Fuji
Boehringer Ingelheim
Teva

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