Lupin gets USFDA nod for generic cystic fibrosis treatment medicine

Pharma major Lupin Ltd on Thursday said it has received tentative approval from the US health regulator to market its generic version of Ivacaftor oral granules used in treatment of cystic fibrosis.

The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Ivacaftor oral granules of strengths 25 mg, 50 mg, and 75 mg per unit dose packet, Lupin said in a statement.

These are the generic equivalent of 'Kalydeco' oral granules, 25 mg, 50 mg, and 75 mg, of Vertex Pharmaceuticals Incorporated.

"Lupin is the exclusive first-to-file for this product and may be eligible for 180 days of generic drug exclusivity," the company said, adding that the product would be manufactured at its Nagpur facility.

Ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet are indicated for the treatment of cystic fibrosis (CF) in patients aged four months and older who have at least one mutation in the 'CFTR' gene that is responsive to Ivacaftor.

Citing IQVIA MAT November 2024 data, the company said Ivacaftor oral granules, 25 mg, 50 mg and 75 mg had an estimated annual sale of USD 51 million in the US.