With Dronabinol already being generic (and FDA approved for AIDS related Anorexia and CINV / Chemo Induced Nausea/Vomiting), Dr. Lippa discussed the rationale for it retaining commercial value in Sleep Apnea against generics (Slide 31) -
1) The method of use patent going to 2025 - the generic company could be sued by Cortex if they were to advertise the use of their generic Dronabinol for Sleep Apnea.
2) Proprietary formulations, and 2 pending dosing patents -
-- a) Proprietary dose - presumably the lowest 2.5 mg dose, but not sure how this would provide patent protection from a generic 2.5 mg product (?)
-- b) Pulse dose formulation - to provide efficacy over the entire night. This is interesting but apparently not yet developed - a 2.5 mg pill which would also contain an additional delayed release 2.5 mg amount of Dronabinol which will kick in at night after the initial 2.5 wears off. Dronabinol's halflife is 2-4 hours, so it only covers the first half night's sleep. But in the Phase 2a it was noted that the low 2.5 mg dose provided the same efficacy as the high 10 mg dose for the first ~ four hours of sleep, creating the opportunity for Cortex to produce a patented dosage form which will include an extra 2.5 mg 'booster' for hours 4-8 hours of sleep. So a clever way to make the Cortex product stand out in the marketplace against generics, although actually developing this dosing form and running some trials will take time.
3) 3rd Party payers - the fact that off-label use of generics and medical marijuana are not covered by 3rd party payers. I wonder though, if once the FDA approval for Sleep Apnea occurs, it then won't be considered off label anymore (?) Hopefully Dr. Lippa will elaborate more on this strategy in future presentations.
