Additional Relevant Details
Under the settlement and license agreement, Horizon has granted Amneal the non-exclusive right to market a generic diclofenac sodium topical 2% w/w solution in the United States under Amneal's Abbreviated New Drug Application (ANDA), beginning January 10, 2029 or earlier under certain circumstances.The agreement includes a stipulation by the parties requesting dismissal without prejudice of the lawsuit filed by Horizon in the U.S. District Court for the District of New Jerseyrelating to the ANDA filed by Amneal with the U.S. Food and Drug Administration for a generic version of PENNSAID 2%.