Lupin has received a tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent (OTC), to market a generic equivalent of Pataday Once Daily Relief, 0.7 percent (OTC), of Alcon Laboratories Inc.

This product will be manufactured at Lupin’s Pithampur facility in India.

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7 percent is indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Olopatadine Hydrochloride Ophthalmic Solution USP (RLD Pataday) had an estimated annual sale of USD 22 million in the US.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the US by prescriptions. The company invested 7.8 percent of its revenue in research and development in FY24.