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Generated: April 24, 2019

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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 022275-001 May 19, 2009 RX Yes No 5,753,677 ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 5,753,677 ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes 5,753,677 ➤ Sign Up ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 RX Yes Yes 8,501,730 ➤ Sign Up Y ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No 8,501,730 ➤ Sign Up Y ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 RX Yes No 8,501,730 ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 5,258,510 ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 5,258,510 ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 5,258,510 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for OTSUKA AMERICA PHARM 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 Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0450097 CA 2009 00031 Denmark ➤ Sign Up
0450097 C300408 Netherlands ➤ Sign Up PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
0450097 300408 Netherlands ➤ Sign Up 300408, 20101018, EXPIRES: 20151017
0450097 09C0049 France ➤ Sign Up PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
0450097 SPC/GB09/037 United Kingdom ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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