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Gavreto · pharmadog

pharmadog
drugs
Gavreto

drug

patient view →

pralsetinib

Marketedupdated 2mo ago

by Blueprint Medicines Corp

Approved

community read0 votes

indications

investigational

NSCLC

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Gavreto

generic

pralsetinib [INN]

indication

Solid Tumor

phase

marketed

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Patent cliff

source: FDA Orange Book

first barrier falls

Sep 4, 2027

~1.2 years out

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

patents (6)

Jul 7, 2042compositionUS 12448366
Apr 3, 2039method-of-use (U-2952)US 11273160
Apr 3, 2039method-of-use (U-2952)US 11872192
Apr 3, 2039method-of-use (U-2828)US 11963958
Apr 3, 2039method-of-use (U-2828)US 12539303
Nov 1, 2036compositionUS 10030005

FDA exclusivities (3)

Dec 1, 2027ODE-340Orphan Drug (7y)1.4y
Dec 1, 2027ODE-341Orphan Drug (7y)1.4y
Sep 4, 2027ODE-318Orphan Drug (7y)1.2y

Data sources

ClinicalTrials.gov

last refreshed 31m ago

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top 2

tagApproval40 co-mentions · 10 sources
tagSmall Molecule20 co-mentions · 10 sources

Trials studying pralsetinib

phase2A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)recruitingn=99
phase2Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Studyactive not recruitingn=920
phase3A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)terminatedn=223
phase2Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumorscompletedn=590
—KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors IIrecruitingn=1,000
phase2A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Responsecompletedn=252
phase3A Study of Pralsetinib Versus Standard of Care (SOC) for Treatment of RET-Mutated Medullary Thyroid Cancer (MTC).withdrawn