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Last Updated: March 28, 2024

ARIPIPRAZOLE - Generic Drug Details


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What are the generic sources for aripiprazole and what is the scope of freedom to operate?

Aripiprazole is the generic ingredient in seven branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Breckenridge, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-two NDAs. There are sixty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has eight hundred and ninety-seven patent family members in forty-eight countries.

There are forty-nine drug master file entries for aripiprazole. Forty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for ARIPIPRAZOLE

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Drug Sales Revenue Trends for ARIPIPRAZOLE

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Recent Clinical Trials for ARIPIPRAZOLE

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
All India Institute of Medical Sciences, BhubaneswarN/A
First Affiliated Hospital of Chongqing Medical UniversityPhase 1/Phase 2

See all ARIPIPRAZOLE clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial15MGTABLET, ORALLY DISINTEGRATING; ORAL
⤷  Try a Trial⤷  Try a Trial10MGTABLET, ORALLY DISINTEGRATING; ORAL
⤷  Try a Trial⤷  Try a Trial30MGTABLET; ORALLY DISINTEGRATING

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ARIPIPRAZOLE
Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ABILIFY MAINTENA KIT Extended-release Injectable Suspension aripiprazole 300 mg/vial and 400 mg/vial 202971 1 2021-12-20
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 ARIPIPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma ARIPIPRAZOLE aripiprazole TABLET;ORAL 203908-004 Oct 8, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx ARIPIPRAZOLE aripiprazole SOLUTION;ORAL 215595-001 Oct 25, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Prinston Inc ARIPIPRAZOLE aripiprazole TABLET;ORAL 205363-004 Dec 4, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 ARIPIPRAZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ARIPIPRAZOLE

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
Zentiva, k.s. Aripiprazole Zentiva aripiprazole EMEA/H/C/003899
Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva 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 Zentiva 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 2015-06-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ARIPIPRAZOLE

Country Patent Number Title Estimated Expiration
Argentina 106449 FORMULACIÓN INYECTABLE DE ARIPIPRAZOL ESTÉRIL DE LIBERACIÓN CONTROLADA LA CUAL, DESPUÉS DE LA INYECCIÓN, LIBERA ARIPIPRAZOL, UNA FORMULACIÓN DE ARIPIPRAZOL ESTÉRIL DE LIBERACIÓN CONTROLADA SECADA POR CONGELAMIENTO, Y UN MÉTODO PARA SU PREPARACIÓN ⤷  Try a Trial
Israel 268511 מערכת לניהול שרשרת אספקה (System for supply chain management) ⤷  Try a Trial
Hong Kong 1166680 藥物信息系統 (PHARMA-INFORMATICS SYSTEM) ⤷  Try a Trial
Mexico 2013008433 DISPOSITIVO MEDICO QUE CONTIENE UNA COMPOSICION EN TORTA QUE COMPRENDE ARIPIPRAZOL COMO INGREDIENTE ACTIVO, Y UNA COMPOSICION EN TORTA QUE COMPRENDE ARIPIRAZOL COMO INGREDIENTE ACTIVO. (MEDICAL DEVICE CONTAINING A CAKE COMPOSITION COMPRISING ARIPIPRAZOLE AS AN ACTIVE INGREDIENT, AND A CAKE COMPOSITION COMPRISING ARIPIPRAZOLE AS AN ACTIVE INGREDIENT.) ⤷  Try a Trial
Slovenia 1660037 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARIPIPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 C01675573/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573 92427 Luxembourg ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 C300669 Netherlands ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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 32/2014 Austria ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.