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Ojemda · pharmadog

pharmadog
drugs
Ojemda

drug

patient view →

tovorafenib

Marketedupdated 2mo ago

by $DAWN Day One Biopharmaceuticals, Inc.

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Ojemda

generic

tovorafenib

indication

Low-Grade Glioma

phase

marketed

Data sources

ClinicalTrials.gov

last refreshed 58m ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Apr 23, 2029

~2.8 years out

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

patents (4)

Jun 23, 2035formulationUS 10426782
Jun 23, 2035formulationUS 10426782
Aug 4, 2031compositionUS 8293752
Aug 4, 2031compositionUS 8293752

FDA exclusivities (4)

Apr 23, 2031ODE-478Orphan Drug (7y)4.8y
Apr 23, 2031ODE-478Orphan Drug (7y)4.8y
Apr 23, 2029NCENew Chemical Entity (5y)2.8y
Apr 23, 2029NCENew Chemical Entity (5y)2.8y

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Trials studying tovorafenib

phase1A Study to Assess a Medicine Called Tovorafenib in Japanese Children and Young Adults With Brain Tumoursrecruitingn=6
phase3DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)active not recruitingn=418
phase2Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adultsrecruitingn=57
phase2Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)not yet recruitingn=79
phase2Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumorsterminatedn=23
phase1Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumorsterminatedn=44
phase2A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumorsrecruitingn=141
—Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Gliomaapproved for marketing

more trials →