Lupin Limited has informed the Exchange regarding a press release dated Jun 26, 2025, titled "Lupin Launches Prucalopride Tablets in the United States ".
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Lupin has launched Prucalopride Tablets (1 mg and 2 mg) in the United States after receiving USFDA approval for its Abbreviated New Drug Application (ANDA). The product is a generic equivalent of Takeda's Motegrity® and is used to treat chronic idiopathic constipation (CIC) in adults. The reference brand had estimated annual US sales of around USD 184 million (IQVIA MAT April 2025). This adds another product to Lupin's US generic portfolio and targets a sizable therapy area. Lupin is a major Indian pharma company with presence in over 100 markets and 15 manufacturing facilities worldwide.
This is a positive development for Lupin as it opens access to a USD 184 million US market opportunity for chronic constipation treatment. The launch strengthens Lupin's US generics pipeline and could contribute to revenue growth, though actual revenue will depend on market share captured and competitive pricing pressure typical of generic launches.