For the first time, FDA is allowing new fixed-dose combination (FDC) drugs to be eligible for five years of New Chemical Entity (NCE) exclusivity. FDA currently provides market-based exclusivity to pharma companies who have been approved to market new drugs, granting them patent protection and disapproving any outside equivalents over a five-year period. Until now, FDC drug products have been ineligible for five-year exclusivity if they consist of any previously approved entities.
FDA has recently released a final guidance document outlining the new standards for exclusivity. While industry’s reaction was seemingly positive, many companies have expressed concerns with the new policy’s lack of retroactivity. FDA explains in the guidance that these new exclusivity standards will only be effective as of October 10, 2014, which is when the document was published, meaning that FDC drugs with prior approval will remain ineligible for this exclusivity.