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Last Updated: November 12, 2024

Tolvaptan - Generic Drug Details


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

Tolvaptan is the generic ingredient in three branded drugs marketed by Otsuka, Alkem Labs Ltd, Apotex, Endo Operations, Hetero Labs Ltd V, and MSN, and is included in seven 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 eighty-six patent family members in twenty-four countries.

There are eight drug master file entries for tolvaptan. Six suppliers are listed for this compound.

Drug Prices for tolvaptan

See drug prices for tolvaptan

Recent Clinical Trials for tolvaptan

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

SponsorPhase
University Medical Center GroningenPhase 3
University of Colorado, DenverPhase 2
University of MarylandPhase 2

See all tolvaptan clinical trials

Pharmacology for tolvaptan
Anatomical Therapeutic Chemical (ATC) Classes for tolvaptan
Paragraph IV (Patent) Challenges for TOLVAPTAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JYNARQUE Tablets tolvaptan 15 mg, 30 mg, 45 mg, 60 mg, 90 mg 204441 1 2021-04-08
SAMSCA Tablets tolvaptan 60 mg 022275 1 2018-03-26
SAMSCA Tablets tolvaptan 15 mg 022275 1 2013-10-10
SAMSCA Tablets tolvaptan 30mg 022275 1 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
Msn TOLVAPTAN tolvaptan TABLET;ORAL 216949-002 Jun 21, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations TOLVAPTAN tolvaptan TABLET;ORAL 206119-001 Feb 15, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-003 May 19, 2009 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 RX Yes No ⤷  Sign Up ⤷  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

Expired US Patents for tolvaptan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-002 Apr 23, 2018 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-005 Apr 23, 2018 ⤷  Sign Up ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-004 Apr 23, 2018 ⤷  Sign Up ⤷  Sign Up
Otsuka SAMSCA tolvaptan TABLET;ORAL 022275-001 May 19, 2009 ⤷  Sign Up ⤷  Sign Up
Otsuka JYNARQUE tolvaptan TABLET;ORAL 204441-001 Apr 23, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for tolvaptan

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V. Jinarc tolvaptan EMEA/H/C/002788
Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.
Authorised no no no 2015-05-27
Otsuka Pharmaceutical Netherlands B.V. Samsca tolvaptan EMEA/H/C/000980
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).,
Authorised no no no 2009-08-02
Accord Healthcare S.L.U. Tolvaptan Accord tolvaptan EMEA/H/C/005961
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Authorised yes no no
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tolvaptan

Country Patent Number Title Estimated Expiration
Japan 5893083 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008156217 ⤷  Sign Up
Japan 2007091738 METHOD OF MANUFACTURING BENZOAZEPIN COMPOUND OR ITS SALT ⤷  Sign Up
Spain 2358217 ⤷  Sign Up
European Patent Office 2251319 Procédés pour préparer des dérivés d' acide benzoïque (Process for preparing derivatives of benzoic acid) ⤷  Sign Up
Austria E544744 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tolvaptan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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 09C0049 France ⤷  Sign Up PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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