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Skyclarys · pharmadog

pharmadog
drugs
Skyclarys

drug

patient view →

omaveloxolone

Marketedupdated 2mo ago

by Reata Pharmaceuticals Inc

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Skyclarys

generic

omaveloxolone

indication

Friedreich Ataxia

phase

marketed

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no comments yet — first sniff?

Patent cliff

source: FDA Orange Book

first barrier falls

Dec 20, 2027

~1.5 years out

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

patents (7)

Apr 24, 2033compositionUS 8993640
Apr 24, 2033compositionUS 9701709
Dec 3, 2029compositionUS 81247993.4y
Apr 20, 2029method-of-use (U-3552)US 110914302.8y
Apr 20, 2029method-of-use (U-3863)US 119198382.8y
Apr 20, 2029formulationUS 84408542.8y
Apr 20, 2029compositionUS 96701472.8y

FDA exclusivities (3)

Feb 28, 2030ODE-427Orphan Drug (7y)3.6y
Feb 28, 2028NCENew Chemical Entity (5y)1.6y
Dec 20, 2027M-270Method (3y)1.5y

Data sources

ClinicalTrials.gov

last refreshed 15m ago

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Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

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top 2

tagApproval20 co-mentions · 5 sources
tagSmall Molecule10 co-mentions · 5 sources

Trials studying omaveloxolone

phase3A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxiarecruitingn=255
phase1A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55recruitingn=70
phase2A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxiacompletedn=172
phase1A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Oldrecruitingn=35
phase1A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55completedn=22
phase1A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55completedn=52
—A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babiesrecruitingn=20
phase2RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTORcompletedn=53

more trials →