FX.co ★ ANI Pharma Launches FDA-Approved Prucalopride Tablets With 180-Day CGT Exclusivity

ANI Pharmaceuticals, Inc. (ANIP) has announced the launch of Prucalopride Tablets, the generic equivalent of the reference listed drug (RLD) Motegrity. This follows the final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).

The FDA has awarded Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, which includes a 180-day period of exclusivity. According to IQVIA data for the moving annual total (MAT) ending October 2024, the annual U.S. sales for Prucalopride Tablets are approximately $168.0 million.