🧪 Lupin Gets US FDA Approval for Prucalopride Tablets
Mumbai, June 2025 – Leading Indian pharmaceutical company Lupin Ltd has announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Prucalopride Tablets, used in the treatment of chronic idiopathic constipation (CIC).
The tablets, available in 1 mg and 2 mg strengths, are the generic equivalent of Motegrity®, marketed in the U.S. by Takeda Pharmaceuticals.
💊 What Is Prucalopride?
Prucalopride is a selective serotonin 5-HT4 receptor agonist used to stimulate bowel movement in adults with chronic constipation when other laxatives have failed. It enhances colonic peristalsis, accelerating bowel transit.
📈 Market Potential and Impact
According to IQVIA data, the annual US market for Prucalopride tablets was approximately $108 million (as of March 2025). Lupin's entry is expected to intensify generic competition and provide a cost-effective treatment alternative for U.S. patients.
🏭 Manufacturing Details
Lupin will manufacture the drug at its Pithampur facility in India, which is already approved by global regulatory bodies, including the US FDA.
✅ Why This Approval Matters for Lupin
Expands Lupin’s presence in the gastroenterology segment
Boosts U.S. generics portfolio amid increasing demand for digestive health products
Reinforces trust in Lupin’s regulatory and compliance capabilities
❓ FAQs
Q1: What is Prucalopride used for?
A: Prucalopride is used to treat chronic idiopathic constipation in adults by stimulating natural bowel movements.
Q2: How does Lupin’s version differ from the original?
A: Lupin’s Prucalopride is a generic version of Takeda’s Motegrity®, offering the same efficacy at a potentially lower price.
Q3: Is Prucalopride safe for long-term use?
A: It is generally well-tolerated, but long-term use should be monitored by a healthcare provider.
Q4: Where will Lupin manufacture this drug?
A: At its Pithampur (Madhya Pradesh) manufacturing facility.
Q5: When will the product be available in the U.S. market?
A: While Lupin has not specified a launch date, approvals typically lead to a commercial rollout within a few months.
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Reported by Benny on June 25, 2025.
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