Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Prucalopride Tablets, 1 mg, and 2 mg. Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. This product will be manufactured at Lupin’s Goa facility in India.
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).