The company has received tentative approval to market its Efinaconazole topical solution, 10%, from the United States Food and Drug Administration (USFDA), Lupin said in a regulatory filing.
The product is a generic version of Bausch Health Americas, Inc’s Jublia topical solution in the same strength, it added.
According to IQVIA MAT September 2020 data, Efinaconazole topical solution, 10% had estimated annual sales of USD 222.9 million (about Rs 1,640 crore) in the US, the filing said.
“Efinaconazole topical solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes,” it added.
Shares of Lupin Ltd on Thursday closed 1.37Â per cent higher at Rs 976.15 per scrip on the BSE.