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Last Updated: August 3, 2020

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Otsuka America Pharm Company Profile

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What is the competitive landscape for OTSUKA AMERICA PHARM, and when can generic versions of OTSUKA AMERICA PHARM drugs launch?

OTSUKA AMERICA PHARM has one approved drug.

There are two US patents protecting OTSUKA AMERICA PHARM drugs.

There are sixty-four patent family members on OTSUKA AMERICA PHARM drugs in nineteen countries and five supplementary protection certificates in four countries.

Summary for Otsuka America Pharm
International Patents:64
US Patents:2
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Otsuka America Pharm

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 022275-001 May 19, 2009 RX Yes No 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 Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 5,753,677   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 8,501,730   Start Trial Y   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 Pharm

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 5,753,677   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 5,258,510   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 5,258,510   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for OTSUKA AMERICA PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 15 mg and 30 mg ➤ Subscribe 2013-09-23
➤ Subscribe Tablets 60 mg ➤ Subscribe 2018-03-26

Supplementary Protection Certificates for Otsuka America Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 09C0049 France   Start Trial PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 SPC/GB09/037 United Kingdom   Start Trial PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803
0450097 300408 Netherlands   Start Trial 300408, 20101018, EXPIRES: 20151017
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
>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:

Merck
Boehringer Ingelheim
AstraZeneca
Moodys
Harvard Business School
Mallinckrodt

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