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Last Updated: October 31, 2020

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OTSUKA Company Profile

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Summary for OTSUKA
International Patents:1004
US Patents:60
Tradenames:14
Ingredients:10
NDAs:16
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 021436-003 Nov 15, 2002 AB RX Yes No 7,053,092   Start Trial   Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No   Start Trial   Start Trial
Otsuka ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No 8,545,402   Start Trial Y   Start Trial
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 DISCN Yes No   Start Trial   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 ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 5,006,528*PED   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 5,753,677   Start Trial
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 5,006,528*PED   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
>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
0450097 C300408 Netherlands   Start Trial PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
1675573 122014000057 Germany   Start Trial PRODUCT NAME: ARIPIPRAZOL; 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 PA2018509,C1869025 Lithuania   Start Trial PRODUCT NAME: BREKSPIPRAZOLAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/18/1294 20180726
>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:

Medtronic
Express Scripts
Moodys
Dow
Johnson and Johnson
Harvard Business School

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