FDA’s ANDA Backlog Poses Threat to Generic Marketing Exclusivity

As the FDA’s backlog in reviewing ANDAs continues to grow, generic-drug makers are now facing a situation where they could potentially lose initial marketing exclusivity on their products as a result. By the end of last year, the number of ANDAs waiting to be reviewed by the agency had reached 2,361, Kurt Karst, an attorney with Hyman, Phelps & McNamara, said Feb. 4. The delay in approval times is a major concern for drugmakers who were the first to file an ANDA for a generic version of a brand drug and would stand to gain 180 days of marketing exclusivity once the application is approved.
Washington Drug Letter