Perrigo announced that Adapt Pharma Operations Limited, Adapt Pharma, Adapt Pharma Ltd. and Opiant Pharmaceuticals initiated patent litigation on October 25, 2018 in the United States District Court for the District of New Jersey regarding Perrigo's Paragraph IV Abbreviated New Drug Application for naloxone hydrochloride nasal spray 4mg, asserting patents listed in the Orange Book for Narcan. This action formally initiates the litigation process under the Hatch-Waxman Act.
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Narcan (naloxone HCl) Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression. Annual market sales for the 12 months ending August 2018 were $95 million as measured by IQVIA.
"This filing is another example of the diligent work done by our skilled R&D, operations and legal teams to develop new extended topical generic products that lower the cost of healthcare," Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski said.