Adamis Pharmaceuticals Announces Patent Litigation Regarding Its Higher Dose Naloxone Injection Product
Adamis Pharmaceuticals Corporation (ADMP)
Last adamis pharmaceuticals corporation earnings: 11/12 04:16 pm
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Source: GlobeNewswire
SAN DIEGO, May 21, 2019 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that on May 20, 2019, it received notice that it had been named and served as a defendant in a lawsuit filed by kaléo Inc. in the United States District Court for the District of Delaware regarding Adamis’ higher dose naloxone injection product candidate for the treatment of opioid overdose, for which Adamis has previously submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) that is being reviewed by the agency. The complaint alleges, among other things, that the company’s product candidate infringes patents purportedly held by kaléo relating to its naloxone auto-injector product. The action was filed under the provisions of the Hatch-Waxman Act in response to Adamis’ Paragraph IV certification regarding the kaléo patents as part of the company’s NDA process, and results in an automatic stay of any final approval by the FDA of Adamis’ NDA.
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