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TOLVAPTAN · pharmadog

pharmadog
drugs
TOLVAPTAN

drug

patient view →

TOLVAPTAN

Marketedupdated 2mo ago

by Otsuka America Pharmaceutical Inc

Approved

community read0 votes

all catalysts(1)

approval · 1

TOLVAPTAN — FDA approval

News(0)

no news has mentioned this drug yet

brand

TOLVAPTAN

generic

TOLVAPTAN

indication

Polycystic Kidney Disease

phase

marketed

Patent cliff

source: FDA Orange Book

first barrier falls

Sep 1, 2026

56 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 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Apr 7, 2030formulationUS 109056943.8y
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d
Sep 1, 2026compositionUS 850173056d

Data sources

openFDA · ClinicalTrials.gov

last refreshed 31m ago

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🐶 often sniffed alongside

top 3

tagApproval2 co-mentions · 1 sources
drugSamsca1 co-mentions · 1 sources
tagSmall Molecule1 co-mentions · 1 sources

Trials studying TOLVAPTAN

phase3A Study to See Iftolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old withAutosomal 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Who at Enrollment Are 28 Days to Less Than 12 Weeks Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)withdrawn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 →