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Last Updated: March 28, 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
Drug Prices for TOLVAPTAN

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Recent Clinical Trials for TOLVAPTAN

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SponsorPhase
University Medical Center GroningenPhase 3
University of Colorado, DenverPhase 2
University of MarylandPhase 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V TOLVAPTAN tolvaptan TABLET;ORAL 205646-001 Jul 16, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex TOLVAPTAN tolvaptan TABLET;ORAL 207605-002 Sep 6, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn TOLVAPTAN tolvaptan TABLET;ORAL 216949-001 Jun 21, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd TOLVAPTAN tolvaptan TABLET;ORAL 211891-001 May 19, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd TOLVAPTAN tolvaptan TABLET;ORAL 211891-002 May 19, 2020 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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