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Last Updated: August 4, 2020

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Otsuka America Company Profile

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Summary for Otsuka America
International Patents:64
US Patents:2
Tradenames:3
Ingredients:2
NDAs:2

Drugs and US Patents for Otsuka America

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 AB RX Yes Yes 8,501,730   Start Trial Y   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 AB RX Yes Yes 5,753,677   Start Trial   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 DISCN No No   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 5,753,677   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 America

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 5,753,677   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 5,753,677   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001 4,830,010   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 5,258,510   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for OTSUKA AMERICA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 60 mg ➤ Subscribe 2018-03-26
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe 2013-09-23

Supplementary Protection Certificates for Otsuka America 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
0450097 CA 2009 00031 Denmark   Start Trial
0450097 09C0049 France   Start Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 300408 Netherlands   Start Trial 300408, 20101018, EXPIRES: 20151017
>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:

Colorcon
McKesson
Medtronic
Harvard Business School
Boehringer Ingelheim
Mallinckrodt

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