Exclusivity/Patent protection.
I have posted something like this before, but here it is. Anavex will have some form of exclusivity for AVXL 2-73 for AD alone not to mention the exclusivity it may have for all of the other uses. It certainly has 5 years FDA exclusivity in the U.S. if there is efficacy for the treatment of AD and FDA approval is granted. However, Anavex is approaching approval for Rhett Syndrome first. Anavex has Orphan Drug Designation for AVXL 2-73 for Rhett. Orphan Drug Designation means faster approval of the drug for that use (for Rhett), and the exclusivity period for an Orphan Drug approval is 7 years. What's more , is that any FDA approval of a drug for any use will open the door for physicians to write off label prescriptions for that durg for any use whether it be for Rhett, Alzheimer's, Parkinson's or anything else.
It may also wind up with 20 years exclusivity from the date of filing (maybe more with patent extensions) patent protection because of the application it has on file in the U.S. about AVXL 2-73 as a monotherapy for AD, which is potentially revivable at any time. Remember too that Anavex allegedly has some foreign patent protection for AVXL alone including, but not limited to, that once controversial Greek patent assigned to Anavex.
Anavex has competent patent counsel. I believe more patent protection will be forthcoming.
If efficacy is proven, any way you look at it Anavex has some exclusivity and a valuable drug.
Patent protection is governed by the Patent and Trademark Office and generally, runs 20 years from the date of filing (there may be some extensions of the 20 year period and some I mention below). FDA approval involves varying periods of exclusivity as follows:
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)
