Alkermes plc (NASDAQ: ALKS) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. This potential new two-month offering would expand the range of ARISTADA dosing intervals to include a third option for patients with schizophrenia. ARISTADA was approved by the FDA in October 2015 as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options.
Alkermes also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application 14/663,042 related to ARISTADA, with allowed claims that will cover methods of treatment for schizophrenia. Alkermes expects this patent to issue within the next few months and expire no earlier than March 2035. A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application.