2 days ago
Lupin gets U.S. FDA nod for Prucalopride Tablets for treatment of CIC in adults
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.
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