Lupin gets U.S. FDA nod for generic of Takeda’s constipation drug 

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for Prucalopride Tablets 1 mg and 2 mg that are indicated for treatment of chronic idiopathic constipation (CIC) in adults.

Prucalopride Tablets are bioequivalent to Motegrity Tablets 1 mg and 2 mg of Takeda Pharmaceuticals U.S.A. Inc, Lupin said on U.S. FDA approving its abbreviated new drug application.

Lupin will manufacture the product at its Goa facility. Prucalopride Tablets 1 mg and 2 mg (reference listed drug Motegrity) had estimated annual sales of $184 million in the U.S, the company said citing IQVIA MAT April 2025 numbers.