Indivior Withdraws 2018 Guidance Due To Competitive Pressures On Suboxone, Sublocade
Executive Summary
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.
You may also be interested in...
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.
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.
Dr. Reddy's Launches First Generic Suboxone Film; Indivior May Seek Injunction
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.