drug · Product Intelligence

Epidiolex 100 mg/mL Oral Solution
Pipeline Intelligence

Epidiolex 100 mg/mL Oral Solution: 2 indexed trials, 2 sponsors; 33 linked Orange Book patents and 4 FDA-linked events where matched.

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2Indexed trials
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2Sponsors
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33Orange Book patent links
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4FDA-linked events

Development evidence

NCT04721691Northwell Health · epilepsyPHASE1
NCT05485831Jazz Pharmaceuticals · epilepsyACTIVE_NOT_RECRUITING

FDA / patent evidence

12661365EPIDIOLEX · app 2103652042-09-24
11160795EPIDIOLEX · app 2103652041-03-01
11406623EPIDIOLEX · app 2103652041-03-01
12102619EPIDIOLEX · app 2103652041-03-01
11865102EPIDIOLEX · app 2103652039-04-26
11207292EPIDIOLEX · app 2103652039-04-26
10918608EPIDIOLEX · app 2103652035-10-13
11096905EPIDIOLEX · app 2103652035-10-13
11065209EPIDIOLEX · app 2103652035-10-13
11400055EPIDIOLEX · app 2103652035-10-13
11311498EPIDIOLEX · app 2103652035-06-17
11357741EPIDIOLEX · app 2103652035-06-17

Regulatory context

FDA_EXCLUSIVITYEPIDIOLEX · ODE-3262027-07-31
FDA_EXCLUSIVITYEPIDIOLEX · ODE-3322027-07-31
FDA_EXCLUSIVITYEPIDIOLEX · M-2702026-10-20
FDA_APPROVALEPIDIOLEX · 2018-09-28

FDA Orange Book coverage is U.S.-specific and is not a substitute for worldwide patent or regulatory review.