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Last Updated: December 7, 2021

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ABILIFY Drug Patent Profile


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When do Abilify patents expire, and what generic alternatives are available?

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

This drug has four hundred and twenty-eight patent family members in fifty-one countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Abilify

A generic version of ABILIFY was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28th, 2015.

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Drug patent expirations by year for ABILIFY
Drug Prices for ABILIFY

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Drug Sales Revenue Trends for ABILIFY

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Recent Clinical Trials for ABILIFY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rutgers, The State University of New JerseyPhase 2
New Jersey Governor's Council for Medical Research and Treatment of AutismPhase 2
New York State Institute for Basic ResearchPhase 2

See all ABILIFY clinical trials

Pharmacology for ABILIFY
Anatomical Therapeutic Chemical (ATC) Classes for ABILIFY
Paragraph IV (Patent) Challenges for ABILIFY
Tradename Dosage Ingredient NDA Submissiondate
ABILIFY SOLUTION;ORAL aripiprazole 021713 2007-12-20
ABILIFY TABLET, ORALLY DISINTEGRATING;ORAL aripiprazole 021729 2006-11-15
ABILIFY TABLET;ORAL aripiprazole 021436 2006-11-15

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 021436-005 Nov 15, 2002 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ABILIFY

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

International Patents for ABILIFY

Country Patent Number Estimated Expiration
Hong Kong 1145291 ⤷  Try it Free
Hungary 228864 ⤷  Try it Free
Poland 360900 ⤷  Try it Free
World Intellectual Property Organization (WIPO) 2004105682 ⤷  Try it Free
Austria A235179 ⤷  Try it Free
Japan 2003212852 ⤷  Try it Free
World Intellectual Property Organization (WIPO) 2004060374 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for ABILIFY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 300669 Netherlands ⤷  Try it Free PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 C300669 Netherlands ⤷  Try it Free PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141 C00367141/01 Switzerland ⤷  Try it Free FORMER REPRESENTATIVE: BOHEST AG, CH
1675573 2014C/029 Belgium ⤷  Try it Free PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141 300161 Netherlands ⤷  Try it Free 300161, 20091027, EXPIRES: 20141026
0367141 C300161 Netherlands ⤷  Try it Free PRODUCT NAME: ARIPIPRAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/276/001-005;006-010;011-015;016-020 20040604
1675573 92427 Luxembourg ⤷  Try it Free PRODUCT NAME: ARIPIPRAZOLE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKesson
Express Scripts
McKinsey
Johnson and Johnson

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