Why Did Suboxone ANDA Applicant Forfeit 180-Day Exclusivity? US FDA's Answer Sets New Policy

Agency reinterprets definition of "first applicant" and applies "failure to market" forfeiture provision of MMA; court halts sales of Dr. Reddy's generic.

The US FDA has clarified when sponsors are eligible for 180-day marketing exclusivity in a letter to applicants of abbreviated new drug applications for generic versions of Indivior PLC's Suboxone (buprenorphine/naloxone) sublingual film.

Specifically, the agency provided a new definition of "first applicant," whereby a sponsor does not lose this status by failing...