Lupin launches generic Prucalopride tablets in US market

USA—Global pharmaceutical company Lupin Limited has announced the launch of its generic Prucalopride tablets in the United States, following the recent approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (FDA).

The tablets are available in 1 mg and 2 mg strengths and are bioequivalent to Motegrity® tablets, marketed by Takeda Pharmaceuticals U.S.A. Inc.

This approval allows Lupin to enter a significant market for the treatment of chronic idiopathic constipation (CIC) in adults, a condition that affects many and impacts quality of life.

Prucalopride acts as a serotonin-4 (5-HT4) receptor agonist, stimulating colonic motility to help restore bowel regularity in patients suffering from CIC.

According to IQVIA MAT data from April 2025, the annual U.S. market sales for Motegrity tablets stood at approximately USD 184 million, highlighting the commercial potential for Lupin’s newly approved generic version.

 Lupin will manufacture these tablets at its state-of-the-art facility in Goa, India, ensuring high-quality production standards.

This regulatory milestone is a strategic step for Lupin as it expands its footprint in the high-margin U.S. generics market, particularly in complex therapies within the gastrointestinal segment.

 The FDA approval confirms the bioequivalence of Lupin’s product to the reference listed drug (RLD), enabling the company to commence commercialization subject to patent and exclusivity considerations.

This launch aligns with Lupin’s broader growth strategy, which focuses on complex generics and differentiated therapies, encompassing therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, central nervous system, and women’s health.

Headquartered in Mumbai, India, Lupin Limited is a global pharmaceutical powerhouse with products distributed in over 100 countries.

The company boasts 15 manufacturing sites and seven research centers worldwide, supported by a dedicated workforce exceeding 23,000 professionals.

Lupin’s portfolio encompasses branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Through its subsidiaries—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions—the company remains committed to improving patient health outcomes globally.

With the launch of Prucalopride tablets in the U.S., Lupin not only taps into a lucrative market worth US$184 million but also reinforces its commitment to providing affordable, high-quality medicines for chronic conditions.

The company’s focus on regulatory excellence and patient care is expected to drive commercial success as it scales up its presence in the gastrointestinal therapeutics space during the second half of 2025 and beyond.

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