Your statement is completely false.
Except for some reason for a few years under Obama these orphan drugs were somehow placed back under patent and awarded to companies that had nothing to do with them.
I don't like Obama any more than anyone else does on this board, but again your statement is false.
GSK decided to get out of the product or sold it off for their own business reasons. A small company picked up the asset where no competition is currently present. They have a window of market uniqueness because there is not competition -- not that a patent is standing on the way of anything.
A generic firm or firms may choose or may have already chosen to file a generic version of this drug with FDA in search of marketing approval.
It is entirely a business decision for a generic firm to file a product with FDA to enter this market, but FDA is not standing in the way of anything here either. In fact it is FDA's policy to put generic approvals on a prioritized review track for an eligible drug product like this one is when there are fewer than 3 generics on the market. Once generic entrants are approved the price for the med will collapse almost overnight.
You need to research things more thoroughly before you post.
FReegards!
