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Global pharma major Lupin Limited has launched Topiramate Extended-Release Capsules in the U.S. market following FDA approval. Available in strengths of 25 mg, 50 mg, 100 mg, and 200 mg, the product is bioequivalent to Trokendi XR® and represents an estimated USD 164 million annual sales opportunity, strengthening Lupin’s generics portfolio.
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Lupin Limited has announced the commercial launch of Topiramate Extended-Release Capsules in the United States, marking another milestone in its global generics expansion strategy. The launch follows the U.S. Food and Drug Administration’s (FDA) approval of Lupin’s Abbreviated New Drug Application (ANDA), reinforcing the company’s commitment to delivering affordable, high-quality medicines.
Notable Updates
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FDA Approval: Lupin received clearance to market Topiramate ER Capsules in multiple strengths (25 mg, 50 mg, 100 mg, and 200 mg).
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Therapeutic Use: The capsules are indicated for treating partial-onset seizures and primary generalized tonic-clonic seizures in patients aged six years and older.
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Market Potential: The product targets an estimated USD 164 million annual sales opportunity in the U.S. generics market.
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Reference Drug: Lupin’s formulation is bioequivalent to Trokendi XR®, marketed by Supernus Pharmaceuticals, Inc.
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Manufacturing Base: Production will take place at Lupin’s Pithampur facility in India, ensuring global supply chain efficiency.
Major Takeaways
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The launch strengthens Lupin’s U.S. generics portfolio, enhancing its presence in neurology-focused therapies.
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FDA approval underscores Lupin’s regulatory compliance and manufacturing excellence.
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The product offers patients a cost-effective alternative to branded therapies, supporting broader access to essential medicines.
Sources: Business Upturn, ScanX News
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