Lupin Receives Tentative USFDA Approval For Generic Ivacaftor Oral Granules
These generic granules are equivalent to Vertex Pharmaceuticals' 'Kalydeco' oral granules in the same strengths.
Lupin Ltd. announced that it has received tentative approval from the US Food and Drug Administration to launch its generic version of Ivacaftor oral granules, used in the treatment of cystic fibrosis.
(Photo source: Company website)
Lupin Ltd. announced that it has received tentative approval from the US Food and Drug Administration to launch its generic version of Ivacaftor oral granules, used in the treatment of cystic fibrosis.
The approval pertains to the abbreviated new drug application for Ivacaftor oral granules in strengths of 25 mg, 50 mg, and 75 mg per unit dose packet.
These generic granules are equivalent to Vertex Pharmaceuticals' 'Kalydeco' oral granules in the same strengths.
"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 in strengths of 25 mg, 50 mg, and 75 mg per unit dose packet are used to treat 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 data for November 2024, the company reported that Ivacaftor oral granules (25 mg, 50 mg, and 75 mg) had an estimated annual sale of $51 million in the US.
In December 2024, Lupin Ltd. announced that it has acquired the Huminsulin portfolio in India from Eli Lilly and Co. as part of its strategy to expand its diabetes range. The company, however, did not reveal the terms of the transaction.
Lupin has been marketing the Huminsulin products, which include Insulin Human, Huminsulin R, Huminsulin NPH, Huminsulin 50/50, and Huminsulin 30/70, through existing distribution and promotional agreements with Lilly in India.
Shares of Lupin Ltd closed 0.03% higher at Rs 2,252.85 per share, compared to a 0.69% decline in the benchmark Nifty. The share price has risen 61.34% in the last 12 months.
Out of 37 analysts tracking the company, 20 have a 'buy' rating on the stock, 10 having a 'hold' rating and seven suggest 'sell', according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 1.1%.
