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Last Updated: May 25, 2022

Aripiprazole - Generic Drug Details


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What are the generic drug sources for aripiprazole and what is the scope of patent protection?

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-five 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.

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

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
Aurobindo Pharma Ltd ARIPIPRAZOLE aripiprazole TABLET;ORAL 203908-005 Oct 8, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boscogen ARIPIPRAZOLE aripiprazole TABLET;ORAL 091279-004 Jan 9, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 AB RX 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;ORAL 021436-003 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for aripiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0367141 SPC/GB04/039 United Kingdom See Plans and Pricing 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 92427 Luxembourg See Plans and Pricing PRODUCT NAME: ARIPIPRAZOLE
1675573 CA 2014 00026 Denmark See Plans and Pricing PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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