Lupin Launches Generic Prucalopride In US Market; Targets $184 mn Segment

Mumbai, June 26, 2025: Pharma major Lupin Ltd (NSE: LUPIN) has announced the launch of its Prucalopride Tablets, 1 mg and 2 mg, in the United States. The move follows the recent approval of its Abbreviated New Drug Application (ANDA) by the US Food and Drug Administration (FDA). It is expected to strengthen Lupin’s presence in the high-margin gastrointestinal therapeutics space in the US, its largest market.

The launch marks its entry into the $184 million chronic idiopathic constipation (CIC) segment. The company’s formulation is a generic version of Motegrity® by Takeda Pharmaceuticals U.S.A. Inc., and is indicated for the treatment of CIC in adults.

Despite opening in green, the stock dipped to an intraday low of ₹1,910.00 before recovering to ₹1,919.40 by 2:03 PM.

U.S. Market Details

According to IQVIA MAT April 2025 data, Prucalopride (marketed as Motegrity®) generated annual sales of approximately USD 184 million in the United States. Lupin’s generic entry is expected to offer a more affordable treatment option for patients, while enabling the company to capture a meaningful share of this niche but lucrative segment.

Strategic Importance

The launch is part of Lupin’s broader strategy to expand its complex generics portfolio and deepen its roots in regulated markets. Furthermore, the launch also aligns with Lupin’s focus areas, complementing its growing base in cardiovascular, respiratory, CNS, and women’s health therapies, particularly in the gastrointestinal segment.

“The launch of Prucalopride reinforces our commitment to bringing high-quality and affordable medications to the US market,” Lupin said in a statement. The company has not disclosed its pricing strategy but is likely to adopt a competitive approach to tap into both retail and institutional demand.

What to Expect?

With USFDA approvals remaining key to growth in North America, Lupin continues to focus on first-to-file and first-to-market opportunities. The successful launch of Prucalopride could help improve the company’s margins in FY26, especially given the relatively limited competition in the segment.

Lupin remains committed to bolstering its speciality and generics pipeline and is expected to announce further product rollouts in the coming quarters. The US launch of Prucalopride comes at a time when Indian pharma companies are regaining momentum in the US generics market, following pricing stability and favourable regulatory trends.

Outlook

As Lupin leverages further US rollout opportunities, the near-term performance is likely to strengthen. The company gets to leverage limited competition and strong demand for affordable generics in this. Investors will closely monitor upcoming FDA approvals, pricing dynamics, and competitive entries to assess the segment’s impact on margins and revenue visibility.

REF: https://nsearchives.nseindia.com/corporate/Lupin2_26062025125224_NSELetterwithPressRelease26062025.pdf

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