Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.) has received the U.S. health regulator approval for a generic to treat fungal toenail infections.
The U.S. Food and Drug Administration has approved the company to manufacture and market Efinaconazole Topical Solution, 10%, the reference listed drug of which is Jublia made by Bausch Health LLC, according to an exchange filing. The drug will be manufactured at the group's topical manufacturing facility at Ahmedabad.
Jublia, 10% had annual sales of $292 million (around Rs 2,335 crore) in the U.S., the filing said citing IQVIA MAT May 2022 data.
Systematix pharma analyst Vishal Manchanda, however, said “patents on this drug have not expired yet and there is ongoing litigation on these patents”. “Therefore, despite approval, the company may not be able to launch it,” he told BQ Prime.
The group now has a total of 317 approvals from the U.S. FDA.
Shares of Zydus Lifesciences closed 3.34% down compared with a 1.43% gain in the Nifty 50 on Monday.
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