ANI Pharmaceuticals Launches Prucalopride Tablets

ANI Pharmaceuticals, Inc. today announced the launch of Prucalopride Tablets, following final approval from the U.S. Food and Drug Administration (FDA)for its Abbreviated New Drug Application (ANDA). These Prucalopride tablets are a generic version of Motegrity®, the reference listed drug(RLD). According to IQVIA data from October 2024, Prucalopride Tablets have an annual market value of approximately $168 million in the United States.

Nikhil Lalwani, President and Chief Executive Officer of ANI, said, "We are delighted to build momentum early in 2025 with the approval of the first generic for Motegrity®, once again highlighting our superior R&D capabilities. The FDA has granted our Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity. ANI continues to hold the second-highest number of CGT approvals in the U.S. Generics market.”