Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Ivacaftor Oral Granules in 25 mg, 50 mg, and 75 mg per unit dose packet. The product is a generic equivalent of Kalydeco Oral Granules by Vertex Pharmaceuticals Incorporated.
Lupin holds the exclusive first-to-file status for this product, which may make it eligible for 180 days of generic drug exclusivity. The granules will be manufactured at Lupin’s Nagpur facility in India.
Ivacaftor Oral Granules are indicated for treating cystic fibrosis in patients aged four months and older who have at least one mutation in the CFTR gene that responds to ivacaftor. According to IQVIA MAT November 2024 data, the reference product Kalydeco had an estimated annual sale of USD 51 million in the U.S.
This development marks Lupin’s planned entry into the cystic fibrosis treatment market, offering a potential cost-effective alternative for patients.