Lupin Launches Prucalopride Tablets to Expand GI Drug Portfolio

Lupin Ltd, the world's largest Indian pharma company, has declared US commercial availability of Prucalopride tablets with strengths of 1 mg and 2 mg. The commercial release was made after obtaining approval from the U.S. Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA).

Lupin's Prucalopride tablets are bioequivalent to Motegrity, a Takeda Pharmaceuticals USA Inc.-developed and marketed drug. Motegrity is an established therapy branded for application in adults with chronic idiopathic constipation (CIC), an illness wherein there is a quality and frequency of bowel movement without any known cause.

As per IQVIA MAT April 2025, Lupin's Prucalopride tablets of 1 mg and 2 mg strengths, as a brand equivalent of the Reference Listed Drug (RLD) Motegrity, accounted for estimated annual U.S. sales of about USD 184 million. The launch provides Lupin with a major opportunity to drive its penetration in the high-value segment of gastroenterology in the U.S. generic market.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with operations in more than 100 markets across the globe. The diversified product basket of the company comprises branded and generic formulations, complex generics, biosimilars, and active pharmaceutical ingredients (APIs). Lupin has been aggressively consolidating its position in the U.S. business through concentrated launches in high-in-demand therapy areas.

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The launch of Prucalopride reaffirms Lupin's focus on making available quality, affordable drugs meeting unmet clinical needs. It also reaffirms the firm's focus on relentless efforts towards building its pipeline of complex generics and capitalizing on future opportunities in regulated markets.

With this launch, Lupin is reaffirming its leadership position in the U.S. pharma market with a goal of creating value for patients and healthcare systems.

The launch is followed by the USFDA’s approval. Click here.