.

BioPharmaceutical Business Intelligence

  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Deloitte
Healthtrust
Colorcon
Dow
QuintilesIMS
Harvard Business School
Covington
Moodys
Cantor Fitzgerald

Generated: December 12, 2017

DrugPatentWatch Database Preview

Aripiprazole - Generic Drug Details

« Back to Dashboard

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

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

Aripiprazole has four hundred and ninety-four patent family members in fifty-one countries and nine supplementary protection certificates in eight countries.

There are forty-four drug master file entries for aripiprazole. Thirty-nine 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
u► Subscribe10MGTABLET, ORALLY DISINTEGRATING; ORAL
u► Subscribe30MGTABLET; ORALLY DISINTEGRATING
u► Subscribe20MGTABLET, ORALLY DISINTEGRATING; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-006Nov 15, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET, ORALLY DISINTEGRATING;ORAL021729-003Jun 7, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaARIPIPRAZOLEaripiprazoleTABLET;ORAL078708-001Apr 28, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncARIPIPRAZOLEaripiprazoleTABLET;ORAL078583-001Jul 24, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ajanta Pharma LtdARIPIPRAZOLEaripiprazoleTABLET;ORAL206174-001Sep 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-005Nov 15, 2002ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Santos BiotechARIPIPRAZOLEaripiprazoleTABLET;ORAL091279-006Jan 9, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-006Nov 15, 2002ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET, ORALLY DISINTEGRATING;ORAL021729-004Jun 7, 2006DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
OtsukaABILIFYaripiprazoleTABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-006Nov 15, 2002► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-001Nov 15, 2002► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-004Nov 15, 2002► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-004Nov 15, 2002► Subscribe► Subscribe
Otsuka Pharm Co LtdABILIFY MAINTENA KITaripiprazoleFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR202971-001Feb 28, 2013► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET, ORALLY DISINTEGRATING;ORAL021729-005Jun 7, 2006► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleSOLUTION;ORAL021713-001Dec 10, 2004► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleINJECTABLE;INTRAMUSCULAR021866-001Sep 20, 2006► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-001Nov 15, 2002► Subscribe► Subscribe
OtsukaABILIFYaripiprazoleTABLET;ORAL021436-003Nov 15, 2002► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: 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
8,030,3125-HT1A receptor subtype agonist► Subscribe
9,763,935Controlled release sterile injectable aripiprazole formulation and method► Subscribe
8,604,041Method of treating panic disorder► Subscribe
8,999,952Aripiprazole complex formulation and method► Subscribe
7,910,589Low hygroscopic aripiprazole drug substance and processes for the preparation thereof► Subscribe
8,680,105Method of treating down's syndrome► Subscribe
9,006,2485-HT.sub.1A receptor subtype agonist► Subscribe
9,694,009Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders► Subscribe
8,722,680Method of treating neurodegenerative diseases► Subscribe
8,952,013Controlled release sterile injectable aripiprazole formulation and method► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: aripiprazole

Country Document Number Estimated Expiration
Peru09232004► Subscribe
China104306337► Subscribe
Hong Kong1129891► Subscribe
Japan5372032► Subscribe
Spain2295677► Subscribe
Malaysia152919► Subscribe
Russian Federation2003132426► Subscribe
China105267151► Subscribe
Poland374798► Subscribe
Malaysia125766► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ARIPIPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573/01Switzerland► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
00669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
9 5013-2014Slovakia► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
427Luxembourg► SubscribePRODUCT NAME: ARIPIPRAZOLE
2014 00026Denmark► SubscribePRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
2014020Lithuania► SubscribePRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
/2014Austria► SubscribePRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
0669Netherlands► SubscribePRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
C/GB04/039United Kingdom► SubscribePRODUCT 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

McKesson
Citi
Fish and Richardson
Merck
Cantor Fitzgerald
Argus Health
Teva
Moodys
Boehringer Ingelheim
Daiichi Sankyo

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot