Lupin Limited, a leading global pharmaceutical company, has announced the launch of its Prucalopride Tablets in 1 mg and 2 mg strengths in the United States, following the recent approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (FDA).
The tablets are the generic equivalent of Motegrity®, originally developed by Takeda Pharmaceuticals U.S.A. Inc., and are approved for the treatment of chronic idiopathic constipation (CIC) in adults—a condition characterized by infrequent or difficult bowel movements without an identifiable cause.
Prucalopride is a selective serotonin-4 (5-HT4) receptor agonist that works by stimulating colonic peristalsis, which helps to restore normal bowel function. Unlike traditional laxatives that act locally in the gut, prucalopride enhances gastrointestinal motility by targeting receptors in the intestinal wall, offering a more physiological and targeted approach to managing chronic constipation. Its use is particularly valuable for patients who have not found relief with fiber, diet changes, or over-the-counter laxatives.
According to IQVIA sales data for the 12 months ending April 2025, the brand-name version of Prucalopride (Motegrity®) generated approximately USD 184 million in annual sales in the U.S. With the launch of its generic version, Lupin is expected to contribute to greater market access and affordability for patients suffering from this chronic condition.
