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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Mallinckrodt
Farmers Insurance
Baxter
Accenture
Cipla
Queensland Health
Fuji
Covington

Generated: November 16, 2018

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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.

Summary for Otsuka America Pharm
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 RX Yes Yes 5,753,677 ➤ Sign Up ➤ 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
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN 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 022275-001 May 19, 2009 5,258,510 ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 5,258,510 ➤ Sign Up
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0408 Netherlands ➤ Sign Up 300408, 20101018, EXPIRES: 20151017
C/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
00408 Netherlands ➤ Sign Up PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803
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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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Medtronic
US Army
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Baxter
Farmers Insurance
Teva

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