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Last Updated: April 23, 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 MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No 8,547,248 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No 7,978,064 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No 10,525,057 ⤷  Try a Trial ⤷  Try a Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No 8,399,469 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No 8,258,962 ⤷  Try a Trial Y ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 RX Yes No 8,945,005 ⤷  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 Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-004 Sep 29, 2014 5,006,528*PED ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-004 Jun 7, 2006 8,642,760*PED ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 9,089,567 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 9,387,182 ⤷  Try a Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 8,642,760 ⤷  Try a Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 8,580,796*PED ⤷  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 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
➤ 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

Supplementary Protection Certificates for Otsuka Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1869025 1890028-2 Sweden ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOLE, OR A SALT THEREOF; REG. NO/DATE: EU/1/18/1294 20180730
1869025 PA2018509 Lithuania ⤷  Try a Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
0287951 SPC/GB98/016 United Kingdom ⤷  Try a 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 SPC/GB18/038 United Kingdom ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/18/1294/001(NI) 20180730; UK PLGB 506970019 20180730; UK PLGB 506970020 20180730; UK PLGB 506970021 20180730; UK PLGB 506970022 20180730; UK PLGB 506970023 20180730; UK EU/1/18/1294/007(NI) 20180730; UK EU/1/18/1294/008(NI) 20180730; UK EU/1/18/1294/009(NI) 20180730; UK EU/1/18/1294/010(NI) 20180730; UK EU/1/18/1294/011(NI) 20180730; UK PLGB 506970024 20180730; UK EU/1/18/1294/002(NI) 20180730; UK EU/1/18/1294/003(NI) 20180730; UK EU/1/18/1294/004(NI) 20180730; UK EU/1/18/1294/005(NI) 20180730; UK EU/1/18/1294/006(NI) 20180730
1869025 18C0004 France ⤷  Try a Trial PRODUCT NAME: BREXPIPRAZOLE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1675573 32/2014 Austria ⤷  Try a Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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