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  1. pharmadog
  2. ›drugs
  3. ›TOLVAPTAN
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TOLVAPTAN

Marketedupdated 3mo ago
by Otsuka America Pharmaceutical Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • tagApproval2 co-mentions · 1 sources
  • drugSamsca1 co-mentions · 1 sources
  • tagSmall Molecule1 co-mentions · 1 sources

all catalysts(1)

approval · 1
Nov 10, 2025
approval
9mo ago
TOLVAPTAN — FDA approval
TOLVAPTAN
→

Trials studying TOLVAPTAN

  • phase3A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)recruitingn=20
  • phase3A Study to See if Tolvaptan Can Delay Dialysis in Infants and Children Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)withdrawn
  • —Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKDcompletedn=1,802
  • phase1A Study of HRS-9057 in Patients With Heart Failure and Volume Overloadcompletedn=25
  • phase1Phase I Study Multi Dose of 7.5mg Tolvaptan in Health Malecompletedn=12
  • phase1Single Dose of 7.5mg Tolvaptan Phase I Clinical Trial Protocolcompletedn=10
  • —Samsca PMS in ADPKD Patientscompletedn=2,067
  • phase2A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremiacompletedn=241
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 1, 2026
12 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (16)

  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Apr 7, 2030formulationUS 109056943.6y
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d
  • Sep 1, 2026compositionUS 850173012d

News(0)

no news has mentioned this drug yet

brand
TOLVAPTAN
generic
TOLVAPTAN
indication
Polycystic Kidney Disease
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 1h ago
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