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Last Updated: January 15, 2021

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OTSUKA Company Profile

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Summary for OTSUKA
International Patents:1007
US Patents:60
Tradenames:14
Ingredients:10
NDAs:16

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 ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes 9,444,503   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd REXULTI brexpiprazole TABLET;ORAL 205422-003 Jul 10, 2015 RX Yes No 8,618,109   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No 10,525,057   Start Trial   Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No 9,089,567   Start Trial   Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 RX Yes No 9,359,302   Start Trial Y Y   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 OTSUKA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 5,006,528*PED   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 5,972,882   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 5,140,993   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 5,006,528*PED   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 5,006,528*PED   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for OTSUKA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe 2007-12-20
➤ Subscribe Orally Disintegrating Tablets 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 2006-11-15
➤ Subscribe Tablets 60 mg ➤ Subscribe 2018-03-26
➤ Subscribe Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe 2006-11-15
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe 2013-09-23
➤ Subscribe Injection 6 mg/mL ➤ Subscribe 2012-12-26

Supplementary Protection Certificates for OTSUKA Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 LUC00086 Luxembourg   Start Trial PRODUCT NAME: BREXPIPRAZOLE OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1294 20180730
1675573 92427 Luxembourg   Start Trial PRODUCT NAME: ARIPIPRAZOLE
1675573 PA2014020 Lithuania   Start Trial PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
0287951 SPC/GB98/016 United Kingdom   Start Trial PRODUCT NAME: GREPAFLOXACIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT INCLUDING GREPAFLOXACIN HYDROCHLORIDE SESQUIHYDRATE; REGISTERED: DE 40682.00.00 19970731; DE 40682.01.00 19970731; DE 40682.02.00 19970731; UK 10949/0299 19971209; UK 10949/0300 19971209
1869025 1890028-2 Sweden   Start Trial PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Mallinckrodt
McKinsey
Boehringer Ingelheim
Johnson and Johnson

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 verification 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.