LUPIN LIMITED

Lupin Limited received U.S. FDA approval for its generic Loteprednol Etabonate Ophthalmic Suspension, 0.5%, equivalent to Lotemax®, for seasonal allergic conjunctivitis relief. Manufactured in India, the product had U.S. sales of USD 59 million (IQVIA MAT Feb 2024). Lupin, a global pharma leader, invests 7.9% of revenue in R&D.

Biosimilars face limited competition, with discounts unlikely to exceed 50% soon. Indian and Chinese biosimilars struggle to enter the US market due to regulatory and quality issues, delaying significant price reductions. Big pharma remains dominant, maintaining higher prices with fewer biosimilars entering the market.

Lupin Limited received tentative US FDA approval for Ivacaftor Tablets, 150 mg, a generic equivalent of Kalydeco. Manufactured in Nagpur, India, it targets a market with $109M annual sales. Lupin, investing 8.7% of FY22 revenue in R&D, operates globally with 15 sites and 20,000+ employees, recognized as a top workplace in pharma.