The launch follows a final approval from the U.S. Food and Drug Administration for Par Health’s Abbreviated New Drug Application. According to IQVIA data, the brand-name drug, manufactured by Merck Sharp & Dohme, recorded approximately $269.9 million in U.S. sales for the 12-month period ending in May 2026.

Jake Longenecker, Executive Vice President and Chief Commercial Officer of Generics at Par Health, stated that the introduction of this first-to-market generic is intended to broaden patient access to affordable treatment options. The company views this development as a significant expansion of its existing generics portfolio, emphasizing a strategy centered on providing lower-cost alternatives for both patients and healthcare providers.