Lupin Secures Tentative USFDA Approval for Ivacaftor Generic

Pharmaceutical company Lupin Ltd. has announced receiving tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivacaftor oral granules. This approval covers strengths of 25 mg, 50 mg, and 75 mg per unit dose packet, making Lupin the exclusive first-to-file applicant for this product. 

This exclusivity could potentially grant the company 180 days of generic drug market exclusivity upon final approval.

Step Into the Cystic Fibrosis Space

Ivacaftor oral granules are used to treat cystic fibrosis in patients as young as four months old, provided they have at least one CFTR gene mutation that responds to Ivacaftor. The granules are packaged in doses of 25 mg, 50 mg, and 75 mg to suit various treatment needs.

The product is Lupin’s generic version of Vertex Pharmaceuticals’ ‘Kalydeco’ granules, which are widely used for this condition. According to November 2024, data from IQVIA MAT, Kalydeco oral granules in these strengths had an estimated annual sale of $51 million in the U.S.

Made in Nagpur

Lupin plans to manufacture the granules at its Nagpur facility in India. This aligns with the company’s approach of leveraging its manufacturing to supply the U.S. market with affordable generic alternatives.

Expanding Its Reach in Diabetes

While establishing its presence in the cystic fibrosis market, Lupin has also broadened its portfolio in the diabetes space. In December, the company acquired the Huminsulin range from Eli Lilly in India. Lupin has been marketing these products for years under a distribution agreement with Lilly, though it hasn’t disclosed the terms of this recent acquisition.

Stock Update

Lupin’s shares were trading at ₹2,211.55, down by ₹41.30 (1.83%) as of 12:20 PM today, on January 10, showing a 21.05% gain over the past six months and a 57.38% rise over the past year.

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