This regulatory green light positions Lupin to manufacture and distribute a bioequivalent alternative for patients diagnosed with narcolepsy, obstructive sleep apnea, or shift work disorder. By securing approval for these specific dosages, the pharmaceutical firm aims to capture a share of the $70.7 million market identified by IQVIA data as of July 2026.
In section Releases
Lupin Cleared to Market Generic Modafinil in U.S.
The U.S. Food and Drug Administration has granted approval to Mumbai-based Lupin Limited for its generic version of Modafinil tablets. The drug, cleared in 100 mg and 200 mg doses, enters a competitive market currently dominated by Nuvo Pharmaceuticals’ Provigil, which generates over $70 million in annual U.S. sales.
Lupin, which operates across 100 global markets, intends to integrate this product into its existing U.S. portfolio. The company maintains an extensive manufacturing network and a research infrastructure that spans six global centers, supporting its strategy to expand access to specialty medicines and generics. This latest addition follows the company’s ongoing efforts to scale its presence in core therapeutic areas including respiratory and cardiovascular health.
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