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Last Updated: June 29, 2022

ARIPIPRAZOLE - Generic Drug Details


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

Aripiprazole is the generic ingredient in six branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in thirty-seven NDAs. There are sixty-six 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 thirty-five patent family members in fifty-two countries.

There are forty-nine drug master file entries for aripiprazole. Forty-six 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
Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoPhase 4
Vanderbilt University Medical CenterPhase 4
Tan Tock Seng HospitalPhase 3

See all ARIPIPRAZOLE clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing30MGTABLET; ORALLY DISINTEGRATING
See Plans and PricingSee Plans and Pricing20MGTABLET, ORALLY DISINTEGRATING; ORAL
See Plans and PricingSee Plans and Pricing15MGTABLET, ORALLY DISINTEGRATING; ORAL

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
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021729-002 Jun 7, 2006 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 See Plans and Pricing See Plans and Pricing
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ARIPIPRAZOLE

Country Patent Number Title Estimated Expiration
Hong Kong 1136961 See Plans and Pricing
China 104306374 See Plans and Pricing
Canada 2689051 SUBSTANCE PHARMACEUTIQUE D'ARIPIPRAZOLE FAIBLEMENT HYGROSCOPIQUE ET METHODES DE PREPARATION ASSOCIEES (LOW HYGROSCOPIC ARIPIPRAZOLE DRUG SUBSTANCE AND PROCESSES FOR THE PREPARATION THEREOF) See Plans and Pricing
Israel 238687 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARIPIPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 2014C/029 Belgium See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 C300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 300669 Netherlands See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 92427 Luxembourg See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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