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Last Updated: March 3, 2024

Otsuka Company Profile


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Summary for Otsuka
International Patents:1007
US Patents:61
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 Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No 7,807,680 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No 10,441,194 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 RX Yes No 10,517,507 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes 8,847,766 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No 8,945,005 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No 8,017,615 ⤷  Try a Trial Y ⤷  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 207202-001 Nov 13, 2017 7,053,092 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 8,642,760*PED ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 4,734,416 ⤷  Try a Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996 4,830,010 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002 9,089,567 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 9,359,302 ⤷  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
0367141 SPC/GB04/039 United Kingdom ⤷  Try a Trial 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
2207786 301256 Netherlands ⤷  Try a Trial PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
1869025 32/2018 Austria ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1294 (MITTEILUNG) 20180727
1675573 C01675573/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573 CA 2014 00026 Denmark ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119
1869025 C01869025/01 Switzerland ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66475 17.07.2018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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