Lupin Gets US FDA Nod for Prucalopride Tablets, Expands GI Portfolio in the U.S.

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Lupin Ltd. (NSE: LUPN) informed that it has obtained final US FDA approval on its Abbreviated New Drug Application (ANDA) of Prucalopride Tablets, which is a generic version of Takeda Pharmaceuticals' Motegrity® (Prucalopride Succinate). The development is a significant addition to Lupin's gastrointestinal (GI) therapeutic portfolio in the US.

About the Drug

Indication: Treatment of chronic idiopathic constipation (CIC) in adults
Mechanism: Prucalopride is a 5-HT4 agonist with selectivity, stimulating colonic motility
Dosage Strengths: Oral tablets 1 mg and 2 mg
Clinical Benefit: Expressed clear improvement in spontaneous complete bowel movements in clinical trials

Market Impact

Prucalopride's U.S. market size is approximately $200 million annually
Lupin's approval positions it to fight in the space of chronic GI disorders, where need for efficacious and well-tolerated therapies is building
The pharmaceutical will be manufactured in Lupin's Nagpur India plant

Regulatory Significance

Approval is with a 180-day Competitive Generic Therapy (CGT) exclusivity, granting Lupin first generic-to-market position in the U.S.
This highlights Lupin's strategy of targeting complex generics and high-barrier-to-entry medicines

Sources: Pharmacy Times, FDA Draft Guidance on Prucalopride Succinate Tablets, Lupin Official Website – Product Pipeline