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Last Updated: November 12, 2024

TOLVAPTAN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Tolvaptan

A generic version of TOLVAPTAN was approved as tolvaptan by ALKEM LABS LTD on May 19th, 2020.

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Drug patent expirations by year for TOLVAPTAN
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Recent Clinical Trials for TOLVAPTAN

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

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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
Alkem Labs Ltd TOLVAPTAN tolvaptan TABLET;ORAL 211891-003 Sep 6, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations TOLVAPTAN tolvaptan TABLET;ORAL 206119-002 Feb 15, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex TOLVAPTAN tolvaptan TABLET;ORAL 207605-002 Sep 6, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V TOLVAPTAN tolvaptan TABLET;ORAL 205646-002 Sep 6, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd TOLVAPTAN tolvaptan TABLET;ORAL 211891-001 May 19, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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