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Generated: February 21, 2018

DrugPatentWatch Database Preview

Aripiprazole - Generic Drug Details

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

Aripiprazole
is the generic ingredient in five branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Silarx Pharms Inc, Alembic Pharms Ltd, Orchid Hlthcare, Accord Hlthcare, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Prinston Inc, Santos Biotech, Sciegen Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Alkermes Inc, and is included in twenty-eight NDAs. There are fifty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has seven hundred and ninety-nine patent family members in fifty-four countries.

There are forty-five drug master file entries for aripiprazole. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for aripiprazole
Medical Subject Heading (MeSH) Categories for aripiprazole
Tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MGTABLET, ORALLY DISINTEGRATING; ORAL
➤ Sign Up➤ Sign Up30MGTABLET; ORALLY DISINTEGRATING
➤ Sign Up➤ Sign Up20MGTABLET, ORALLY DISINTEGRATING; ORAL

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 Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Ajanta Pharma Ltd ARIPIPRAZOLE aripiprazole TABLET;ORAL 206174-002 Sep 12, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 DISCN Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Apotex Inc ARIPIPRAZOLE aripiprazole TABLET;ORAL 078583-004 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

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Expired US Patents for aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for aripiprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,161,707 Communication system incorporated in an ingestible product ➤ Sign Up
8,912,908 Communication system with remote activation ➤ Sign Up
8,901,130 Low hygroscopic aripiprazole drug substance and processes for the preparation ➤ Sign Up
8,810,409 Multi-mode communication ingestible event markers and systems, and methods of using the same ➤ Sign Up
8,030,312 5-HT1A receptor subtype agonist ➤ Sign Up
9,198,608 Communication system incorporated in a container ➤ Sign Up
8,623,874 Method of treating neurodegenerative diseases ➤ Sign Up
9,649,066 Communication system with partial power source ➤ Sign Up
8,952,013 Controlled release sterile injectable aripiprazole formulation and method ➤ Sign Up
9,694,009 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for aripiprazole

Supplementary Protection Certificates for aripiprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014020 Lithuania ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
427 Luxembourg ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE
1675573/01 Switzerland ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
0669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
00669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
C/GB04/039 United Kingdom ➤ Sign Up 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
9 5013-2014 Slovakia ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
/2014 Austria ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
2014 00026 Denmark ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Julphar
Chubb
Citi
Colorcon
Dow
Teva
Express Scripts

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