Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg.

The FDA has approved Lupin’s Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to the Reference Listed Drug (RLD), Provigil Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, Obstructive Sleep Apnea (OSA) or Shift Work Disorder (SWD).

As per IQVIA MAT Jul 2026, Modafinil Tablets (RLD Provigil) had estimated annual sales of USD 70.7 million in the US.