Lupin’s Modafinil Approval Sparks Mixed Market Reaction

Lupin Ltd. announced on Wednesday that the United States Food and Drug Administration has green‑lit its abbreviated new drug application (ANDA) for Modafinil tablets USP, available in 100 mg and 200 mg strengths. The approval means the company can now market these tablets in the U.S., positioning them as a cost‑effective alternative to the well‑known Provigil from Nuvo Pharmaceuticals.

Modafinil is used to boost wakefulness in adults who suffer from excessive daytime sleepiness caused by narcolepsy, obstructive sleep apnea (OSA) or shift‑work disorder (SWD). The FDA’s decision noted that Lupin’s tablets are bio‑equivalent to the reference listed drug, which should reassure physicians and patients alike about efficacy and safety.

Despite the regulatory win, the market’s response was muted. At 09:27 IST, Lupin’s shares on the BSE were trading at ₹2,106.00 – down ₹5, or roughly 0.24 percent, from the previous close. The dip was modest; the stock had ended the prior session at ₹2,111, a 1.12 percent fall from the day before.

Looking at the longer view, the share price still sits well below its 52‑week high of ₹2,530 (recorded on 16 July 2026) and comfortably above the 52‑week low of ₹1,900.30 (set on 28 Oct 2025). In other words, the stock is about 16.5 percent shy of its peak but roughly 11 percent higher than its trough.

Beyond the Modafinil news, Lupin’s subsidiary VISUfarma B.V. struck an exclusive licensing deal in August with Visus Therapeutics, a Tenpoint Therapeutics offshoot. The agreement grants VISUfarma the rights to commercialise, market, promote, distribute and sell the brand‑name product YUVEZZI.

At present, Lupin’s market capitalisation hovers around ₹96,528.82 crore. Investors will likely be watching how the new US‑approved product performs, especially as the company continues to expand its portfolio through strategic partnerships.