Lupin Secures US FDA Tentative Approval For Generic Pataday

Lupin Limited, a leading pharmaceutical firm, declared that it has secured a tentative endorsement from the US Food and Drug Administration (FDA) for its Abbreviated New Medication Application for olopatadine hydrochloride ophthalmic arrangement USP, 0.7% (OTC), to commercialize a generic equivalent Pataday once daily relief, 0.7% (OTC), of Alcon Labs Inc. The product will be produced at Lupin’s pithampur plant in India.

Olopatadine hydrochloride ophthalmic solution USP, 0.7% is showcased for the temporary relief of itchy eyes caused by pollen, grass, ragweed, and animal hair. Olopatadine hydrochloride ophthalmic arrangement USP (Pataday) had an expected annual sale of USD 22 million in the US (IQVIA MAT April 2024).

Lupin is a multinational pharmaceutical company driven by innovation with its headquarters in Mumbai, India. Over 100 markets in the United States, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East are served by the company's biotechnology products, APIs, and branded and generic formulations.

Paediatrics, cardiovascular, anti-infectives, diabetology, asthma, and anti-tuberculosis are the company's primary focus areas. Lupin's IRF business centers around Way of life sicknesses and Chronic disease therapy segments, especially in Cardiology, Central Nervous system (CNS), Diabetology, Anti-Asthma, Anti-Infective, Gastro Digestive and Oncology.