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Last Updated: February 28, 2021

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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, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, and Alkermes Inc, and is included in thirty-six 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-six patent family members in fifty-seven countries.

There are forty-nine drug master file entries for aripiprazole. Forty-two 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
The First Affiliated Hospital of Kunming Medical CollegePhase 2
Guizhou Provincial People's HospitalPhase 2
West China HospitalPhase 2

See all ARIPIPRAZOLE clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial30MGTABLET; ORALLY DISINTEGRATING
  Start Trial  Start Trial20MGTABLET, ORALLY DISINTEGRATING; ORAL
  Start Trial  Start Trial15MGTABLET, 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 NDA Submissiondate
ABILIFY SOLUTION;ORAL aripiprazole 021713 2007-12-20
ABILIFY TABLET;ORAL aripiprazole 021436 2006-11-15
ABILIFY TABLET, ORALLY DISINTEGRATING;ORAL aripiprazole 021729 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 aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Zydus Pharms ARIPIPRAZOLE aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 090165-001 Aug 28, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare ARIPIPRAZOLE aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 202547-001 Dec 11, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Zydus Pharms ARIPIPRAZOLE aripiprazole TABLET;ORAL 090472-006 Jan 7, 2019 DISCN No No   Start Trial   Start Trial   Start 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 021729-005 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013   Start Trial   Start Trial
>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
1675573 C01675573/01 Switzerland   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573 C300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 122014000057 Germany   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 2014C/029 Belgium   Start Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573 32/2014 Austria   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
1675573 300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141 SPC/GB04/039 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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