Lupin Secures FDA Approval for Prucalopride Constipation Drug

Lupin Limited, a multinational pharmaceutical company based in Mumbai, informed that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) on Prucalopride Tablets 1 mg and 2 mg. These are generic equivalents of Motegrity developed by Takeda Pharmaceuticals U.S.A., Inc.

The drug is likely to be prescribed for treating chronic idiopathic constipation (CIC) in adults, a condition where the bowels are difficult to move and chronic without food or any other reason.

Manufacturing of the cleared drug will take place at Lupin's world-class facility in Goa, India. This is yet another milestone for Lupin as it continues to build its portfolio of generics in the highly competitive U.S. pharma marketplace.

As per IQVIA MAT data in April 2025, it showed that Prucalopride Tablets had an estimated US annual sales value of about US dollar 184 million; this gives an idea of the market potential for Lupin's recent approval.

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Lupin leads the pharma world, having a very strong collection that includes branded and generic formulations, complex generics, biosimilars, and active pharmaceutical ingredients (APIs). Its products reach over 100 countries. It further strengthens its position in regulated markets-in the U.S. and others.

Earlier, Lupin had obtained approval from the USFDA for its 150 mg, 300 mg, and 600 mg strength Oxcarbazepine ER tablets. 

This latest FDA approval reflects Lupin’s capability in creating and producing complex generics plus strategy to strengthen its place in the therapeutic field of the gastrointestinal.