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Last Updated: August 5, 2020

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TOLVAPTAN - Generic Drug Details

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What are the generic drug sources for tolvaptan and what is the scope of patent protection?

Tolvaptan is the generic ingredient in three branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka America Pharm, Alkem Labs Ltd, and Apotex, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tolvaptan has seventy-seven patent family members in nineteen countries.

There are eight drug master file entries for tolvaptan. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for TOLVAPTAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Gia Dinh People HospitalN/A
Otsuka Pharmaceutical VietnamN/A
Palladio BiosciencesPhase 3

See all TOLVAPTAN clinical trials

Generic filers with tentative approvals for TOLVAPTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial30MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL
  Start Trial  Start Trial30MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TOLVAPTAN
Paragraph IV (Patent) Challenges for TOLVAPTAN
Tradename Dosage Ingredient NDA Submissiondate
SAMSCA TABLET;ORAL tolvaptan 022275 2018-03-26
SAMSCA TABLET;ORAL tolvaptan 022275 2013-10-10
SAMSCA TABLET;ORAL tolvaptan 022275 2013-09-23

US Patents and Regulatory Information for TOLVAPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009 AB RX Yes Yes   Start Trial   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 TOLVAPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm Co Ltd JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009   Start Trial   Start Trial
Otsuka America Pharm SAMSCA tolvaptan TABLET;ORAL 022275-002 May 19, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TOLVAPTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 2009 00031 Denmark   Start Trial
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Moodys
Merck
Harvard Business School
Colorcon

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