ANI Pharmaceuticals, Inc., a diversified biopharmaceutical company, announced that following final approval from the US 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 US generics market,” stated Nikhil Lalwani, president and chief executive officer of ANI.
US annual sales for prucalopride tablets total approximately $168.0 million, based on October 2024 moving annual total (MAT) IQVIA data.
ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives"" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The company is focused on delivering sustainable growth through its rare disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its generics business, which leverages R&D expertise, operational excellence, and US-based manufacturing; and its established brands business.