Lupin’s Loteprednol Etabonate Ophthalmic Suspension Gains USFDA Approval


Pharmaceutical giant Lupin Ltd announced that it has secured approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) concerning loteprednol etabonate ophthalmic suspension, 0.2%. The approval allows the company to market a generic version of the reference listed drug Alrex® Ophthalmic Suspension, 0.2%, originally developed by Bausch & Lomb Inc.

Generic Solution for Seasonal Allergic Conjunctivitis

Loteprednol etabonate ophthalmic suspension, 0.2%, serves as a generic equivalent specifically designed to provide temporary relief from the signs and symptoms associated with seasonal allergic conjunctivitis. This approval is a significant milestone, contributing to Lupin’s commitment to addressing the medical needs of individuals experiencing allergic reactions affecting their eyes.


Manufacturing and Accessibility

The newly-approved medication is manufactured at Lupin’s advanced facility in Pithampur, India. This approval is expected to enhance accessibility to an effective treatment for seasonal allergic conjunctivitis. Lupin’s dedication to maintaining high-quality manufacturing standards reinforces the reliability and safety of the generic equivalent.

Market Potential and Annual Sales

The approved product is estimated to have annual sales of $29.1 million in the US, based on IQVIA MAT October 2023 data. This significant market potential positions Lupin to make a substantial impact, providing a cost-effective alternative for patients seeking relief from seasonal allergic conjunctivitis.

Lupin’s Global Presence

Lupin operates globally, developing and commercializing a diverse range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs). With a presence in over 100 markets, including the US, India, South Africa, Asia Pacific, Latin America, Europe, and the Middle East, Lupin continues to contribute to the global healthcare landscape.


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