Hi All,
I have a bit of info regarding the difference between the normal 20 year life span of a patent and the 7 year exclusivity offered by the Orphan Drug Act.
The patent still expires 20 years after it being lodged, but ODD allows the FDA to withhold approval of a competitors application for a generic drug for a further 7 years if they wish. [Not sure if it is guaranteed]
I think PAAs patent for Neurological applications expires in 2032. But not 100% sure.
Cheers
FDA Application for Orphan Drug Designation , PAA, MPL, page-280
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