- Two strengths of 1 mg and 2 mg approved for US market
- Product equivalent to Takeda’s Motegrity; US market estimated at $100 million
NE BUSINESS BUREAU
MUMBAI, JULY 29
Alembic Pharmaceuticals has added another USFDA-approved product to its growing US portfolio, securing final regulatory clearance for Prucalopride Tablets in 1 mg and 2 mg strengths—an approval that strengthens its presence in the gastrointestinal therapeutics segment of the world’s largest pharmaceutical market.
The company said it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg and 2 mg.
The approved product is therapeutically equivalent to Motegrity Tablets, the reference listed drug (RLD) of Takeda Pharmaceuticals USA Inc. Prucalopride is a serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Detailed indications are as per the approved product label.
The latest approval comes with a sizeable commercial opportunity. According to IQVIA data cited by Alembic, the US market for Prucalopride Tablets, 1 mg and 2 mg, was estimated at $100 million for the 12 months ended March 2026.
The approval adds another product to Alembic’s expanding US regulatory pipeline and takes the company’s cumulative tally of USFDA ANDA approvals to 245, comprising 225 final approvals and 20 tentative approvals.
For Alembic, the latest clearance underscores its continuing focus on developing and commercialising generic medicines for high-value international markets, while broadening its product basket across therapeutic segments.
