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Last Updated: March 29, 2024

Otsuka Company Profile


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Summary for Otsuka
International Patents:1007
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 ASIMTUFII aripiprazole SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 217006-002 Apr 27, 2023 RX Yes Yes 11,638,757 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 AB RX Yes No 9,125,939 ⤷  Try a Trial ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No 9,060,708 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No 11,476,952 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  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 aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 8,642,600*PED ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 9,359,302 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 8,580,796*PED ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 7,053,092 ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 9,089,567 ⤷  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 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
➤ 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

Supplementary Protection Certificates for Otsuka Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 32/2014 Austria ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
1869025 18C0004 France ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025 122018000088 Germany ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 20180726
1869025 C20180022 00264 Estonia ⤷  Try a Trial PRODUCT NAME: BREKSPIPRASOOL;REG NO/DATE: EU/1/18/1294 30.07.2018
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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