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Last Updated: November 2, 2024

ARIPIPRAZOLE Drug Patent Profile


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

Aripiprazole is a drug marketed by 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, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, and Zydus Pharms. and is included in thirty-four NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Aripiprazole

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

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Drug patent expirations by year for ARIPIPRAZOLE
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Recent Clinical Trials for ARIPIPRAZOLE

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SponsorPhase
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 4
Instituto de Salud Carlos IIIPhase 4
All India Institute of Medical Sciences, BhubaneswarN/A

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Pharmacology for ARIPIPRAZOLE
Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE
Anatomical Therapeutic Chemical (ATC) Classes 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
Hetero Labs Ltd V ARIPIPRAZOLE aripiprazole TABLET;ORAL 205064-006 Apr 28, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc ARIPIPRAZOLE aripiprazole TABLET;ORAL 205363-005 Dec 4, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd ARIPIPRAZOLE aripiprazole TABLET;ORAL 207105-005 Feb 21, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic ARIPIPRAZOLE aripiprazole TABLET;ORAL 202101-002 Apr 28, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Norvium Bioscience ARIPIPRAZOLE aripiprazole TABLET;ORAL 206240-002 Sep 19, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ARIPIPRAZOLE aripiprazole TABLET;ORAL 078608-001 Apr 28, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex ARIPIPRAZOLE aripiprazole TABLET;ORAL 078583-001 Jul 24, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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
Sandoz GmbH Aripiprazole Sandoz aripiprazole EMEA/H/C/004008
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Sandoz 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 Sandoz 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 2015-08-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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