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Serving leading biopharmaceutical companies globally:

UBS
Accenture
Cerilliant
Johnson and Johnson
Teva
Federal Trade Commission
QuintilesIMS
McKinsey
Argus Health
US Department of Justice

Generated: January 23, 2018

DrugPatentWatch Database Preview

Otsuka Company Profile

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Summary for Otsuka
International Patents:545
US Patents:28
Tradenames:11
Ingredients:9
NDAs:13

Drugs and US Patents for Otsuka

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 REXULTI brexpiprazole TABLET;ORAL 205422-001 Jul 10, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 DISCN No No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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 Otsuka

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka RAXAR grepafloxacin hydrochloride TABLET;ORAL 020695-001 Nov 6, 1997 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ➤ Subscribe ➤ Subscribe
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 ➤ Subscribe ➤ Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ➤ Subscribe ➤ Subscribe
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-002 Nov 15, 2002 ➤ Subscribe ➤ Subscribe
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OTSUKA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe 9/23/2013
➤ Subscribe Injection 6 mg/mL ➤ Subscribe 12/26/2012
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe 12/20/2007
➤ Subscribe Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 11/15/2006
➤ Subscribe Orally Disintegrating Tablets 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 11/15/2006

Non-Orange Book US Patents for Otsuka

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
8,901,303 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,999,952 Aripiprazole complex formulation and method ➤ Subscribe
9,480,686 Piperazine-substituted benzothiophenes for treatment of mental disorders ➤ Subscribe
9,006,248 5-HT.sub.1A receptor subtype agonist ➤ Subscribe
5,258,510 United States Patent: 5258510   ( 1 ➤ Subscribe
8,901,130 Low hygroscopic aripiprazole drug substance and processes for the preparation ➤ Subscribe
9,206,167 Piperazine-substituted benzothiophenes for treatment of mental disorders ➤ Subscribe
8,273,735 Process for preparing benzazepine compounds or salts thereof ➤ Subscribe
8,703,772 Low hygroscopic aripiprazole drug substance and processes for the preparation thereof ➤ Subscribe
8,623,874 Method of treating neurodegenerative diseases ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for Otsuka Drugs

Supplementary Protection Certificates for Otsuka Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
427 Luxembourg ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLE
2014 00026 Denmark ➤ Subscribe PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
C/GB04/039 United Kingdom ➤ Subscribe 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
2009 00031 Denmark ➤ Subscribe
1675573/01 Switzerland ➤ Subscribe PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
9 5013-2014 Slovakia ➤ Subscribe PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
2014020 Lithuania ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
0669 Netherlands ➤ Subscribe PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0408 Netherlands ➤ Subscribe 300408, 20101018, EXPIRES: 20151017
/2014 Austria ➤ Subscribe PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Healthtrust
Boehringer Ingelheim
Baxter
Citi
Covington
Johnson and Johnson
Julphar
Farmers Insurance

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.

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