Based on FDA feedback, Adamis Pharmaceuticals (ADMP -4.5%) has removed kaléo’s EVZIO (naloxone HCl injection) 2 mg auto-injector as the Reference Listed Drug (RLD) in its marketing application seeking approval for its higher dose naloxone injection product for the emergency treatment of opioid overdose. It has also withdrawn the associated Paragraph IV certification (enables a generic drug maker to challenge an existing patent in court after notifying the patent holder).
The company hopes that the agency will now approve the application in a timely fashion since the sole remaining RLD is Narcan injectable which has no Orange Book-listed patents. The agency’s action date is October 31.
Adamis is being sued for patent infringement by kaléo but believes that its higher dose formulation does not infringe, adding that it will “continue to vigorously defend its naloxone injection product” against any infringement allegations.
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