Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg and 2 mg. These tablets are the generic equivalent of Motegrity® Tablets by Takeda Pharmaceuticals U.S.A., Inc.
The approved product will be manufactured at Lupin’s state-of-the-art facility in Goa, India.
Prucalopride Tablets are used for the treatment of chronic idiopathic constipation (CIC) in adults, a condition that causes difficult or infrequent bowel movements without a known cause. The drug works by stimulating bowel movements through selective serotonin 5-HT4 receptor agonism.
According to IQVIA MAT data for April 2025, Prucalopride Tablets (1 mg and 2 mg) had estimated annual sales of USD 184 million in the U.S., highlighting the strong market potential for Lupin’s generic version.
This approval reinforces Lupin’s position as a leading provider of high-quality, affordable generics in the U.S. pharmaceutical market.
