ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity.
“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,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.
U.S. annual sales for Prucalopride Tablets total approximately $168.0 million, based on October 2024 moving annual total (MAT) IQVIA data.
