Shares of Lupin experienced a 3% surge during early trading on November 24, a day after it disclosed tentative approval from the United States Food and Drug Administration (USFDA) for a diabetes medication and an ophthalmic Solution.

Shares of Lupin opened 1.98% higher at Rs 1,220 and jumped to an intraday high of Rs 1,238.80, up 3.36% from the last closing price on the National Stock Exchange (NSE). At 11 am, The stock was trading 3.08% higher at Rs 1,235.00 apiece. 

Lupin announced that the USFDA had given tentative approval for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets, a generic equivalent of Invokana Tablets by Janssen Pharmaceuticals, Inc. The approval covers manufacturing at Lupin’s Pithampur facility.

Furthermore, Lupin secured USFDA approval for its ANDA concerning Bromfenac Ophthalmic Solution, 0.07%. This approval positions Lupin as the exclusive first-to-file entity for the generic equivalent of Bausch & Lomb Inc’s Prolensa Ophthalmic Solution, 0.07%, granting the company a coveted 180-day exclusivity period.

The Bromfenac Ophthalmic Solution addresses a crucial medical need and is designed for postoperative inflammation treatment and reducing ocular pain in individuals after cataract surgery. This pharmaceutical product will be manufactured at Lupin’s advanced facility in Pithampur, India.

According to IQVIA data, as of September 2023, Bromfenac Ophthalmic Solution, with its reference listed drug (RLD) being Prolensa, achieved estimated annual sales of $185 million in the US.