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.
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Suboxone market share has declined with the at-risk launch of Dr. Reddy’s generic competitor, while Indivior awaits a court decision on a requested temporary restraining order against the launch.
Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.
Shares in Indivior slid nearly 40% on news of a US court ruling which raises chances its key opioid addiction treatment may face generic competition sooner than expected.