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Last Updated: May 12, 2024

Otsuka Company Profile


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Summary for Otsuka
International Patents:1017
US Patents:56
Tradenames:15
Ingredients:10
NDAs:17
Patent Litigation for Otsuka: See patent lawsuits for Otsuka

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 aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 AB RX Yes No 8,017,615*PED ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka REXULTI brexpiprazole TABLET;ORAL 205422-005 Jul 10, 2015 AB RX Yes No 8,349,840 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No 9,268,909 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 RX Yes No 11,229,378 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No 8,258,962 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-002 Feb 28, 2013 RX Yes Yes 11,400,087 ⤷  Try a Trial ⤷  Try a 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 ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 8,642,760 ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 9,089,567 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 8,642,760*PED ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 8,338,428 ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 8,580,796 ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 9,387,182 ⤷  Try a 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 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
➤ 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

Supplementary Protection Certificates for Otsuka Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 PA2023538 Lithuania ⤷  Try a Trial PRODUCT NAME: CEDAZURIDINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1756 20230915
1675573 C300669 Netherlands ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 92427 Luxembourg ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOLE
0287951 C980011 Netherlands ⤷  Try a Trial PRODUCT NAME: GREPAFLOXACINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AA NVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET EEN ALKANOL MET 1-6 KOOLSTOFATOMEN, IN HET BIJZONDER GREPAFLOXACINI HYDROCHLOR IDUM SESQUIHYDRATUM; NAT. REGISTRATION NO/DATE: RVG 21894, RVG 21895 19971113; FIRST REGISTRATION: DE 40682.00.00, 40682.01.00, 40682.02.00 19970731
1869025 CR 2018 00028 Denmark ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL ELLER ET SALT DERAF; REG. NO/DATE: EU/1/18/1294/001-006 20180727
0451216 99C0028 Belgium ⤷  Try a Trial PRODUCT NAME: GREPAFLOXACINE; CHLORHYDRATE SESQUIHYDRATE; NAT. REGISTRATION NO/DATE: NL 23 373 19990525; FIRST REGISTRATION: DE - 4062.00.00 19970731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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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.