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Last Updated: March 18, 2024

ABILIFY Drug Patent Profile


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Which patents cover Abilify, and what generic alternatives are available?

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

This drug has three hundred and one patent family members in thirty-nine countries.

The generic ingredient in ABILIFY is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-eight 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 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
Genuine Research Center, EgyptPhase 1
P&C Labs, EgyptPhase 1
University of ChicagoPhase 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 Strength NDA ANDAs Submitted Submissiondate
ABILIFY Oral Solution aripiprazole 1 mg/mL 021713 1 2007-12-20
ABILIFY Tablets aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg 021436 8 2006-11-15
ABILIFY Orally Disintegrating Tablets aripiprazole 10 mg, 15 mg, 20 mg and 30 mg 021729 1 2006-11-15

US Patents and Regulatory Information for ABILIFY

ABILIFY is protected by four US patents.

Patents protecting ABILIFY

Aripiprazole complex formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Carbostyril derivatives and mood stabilizers for treating mood disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-001 Apr 27, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 021436-003 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ABILIFY

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) aripiprazole EMEA/H/C/003803
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised yes no no 2015-06-30
Otsuka Pharmaceutical Netherlands B.V. Abilify aripiprazole EMEA/H/C/000471
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
Authorised no no no 2004-06-04
Otsuka Pharmaceutical Netherlands B.V. Abilify Maintena aripiprazole EMEA/H/C/002755
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Authorised no no no 2013-11-14
Accord Healthcare S.L.U. Aripiprazole Accord aripiprazole EMEA/H/C/004021
Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment., , Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.,
Authorised yes no no 2015-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ABILIFY

See the table below for patents covering ABILIFY around the world.

Country Patent Number Title Estimated Expiration
Poland 219565 ⤷  Try a Trial
Malaysia 140793 ARIPIPRAZOLE COMPLEX FORMULATION AND METHOD ⤷  Try a Trial
Serbia 55392 BRZO TOPLJIVA FORMULACIJA ZA ORALNO DOZIRANJE (FLASHMELT ORAL DOSAGE FORMULATION) ⤷  Try a Trial
Norway 324606 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ABILIFY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 SPC/GB04/039 United Kingdom ⤷  Try a Trial 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
1675573 2014C/029 Belgium ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
0367141 300161 Netherlands ⤷  Try a Trial 300161, 20091027, EXPIRES: 20141026
0367141 C00367141/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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