NEW YORK CITY (dpa-AFX) - Acura Pharmaceuticals Inc. (ACUR), which develops products to address medication abuse and misuse, said Thursday it has received notification from a generic sponsor of the filing of an Abbreviated New Drug Application for a generic drug listing Pfizer Inc.'s (PFE) OXECTA (oxycodone HCl) Tablets CII as the reference listed drug.
OXECTA is covered by U.S. patents issued to Acura and licensed to Pfizer. The notification includes a Paragraph IV certification indicating the generic sponsor believes Acura's patents are invalid, unenforceable or not infringed. Acura said it plans to take appropriate action to enforce its intellectual property.
In June 2011, the U.S. Food and Drug Administration approved OXECTA which incorporates Acura Pharmaceuticals' proprietary AVERSION technology.
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