GI Gains: Lupin Targets $184M Market with New FDA-Approved Tablets

Image Source: Express Pharma

Lupin Ltd has begun marketing its Prucalopride Tablets 1 mg and 2 mg in the United States following approval of its Abbreviated New Drug Application (ANDA) from the FDA. The drug is a generic bioequivalent of Takeda's Motegrity® and is approved to be used for adults with Chronic Idiopathic Constipation (CIC). This is a strategic addition in Lupin's U.S. business, entering a $184 million per annum market.

Product Overview

Drug Name: Prucalopride Tablets (1 mg and 2 mg)
Indication: Adults with Chronic Idiopathic Constipation (CIC)
Reference Brand: Motegrity® by Takeda Pharmaceuticals U.S.A. Inc.
Manufacturing Site: Lupin's Goa plant, India

Market Impact

U.S. Market Size: Estimated at $184 million (IQVIA, April 2025)
Strategic Fit: Strengthens Lupin's gastrointestinal and generics business in the U.S.
Competitive Edge: Offers a value-for-money alternative in a growing therapeutic class

Operational Highlights

Facility: Manufactured at Lupin's state-of-the-art facility in Goa
Regulatory Success: U.S. FDA approved through ANDA
Portfolio Expansion: Unfolds at the back of recent U.S. approvals like Oxcarbazepine ER Tablets

Sources: Financial Express, CNBC TV18, Lupin Official Announcement