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Lupin's Allergic Conjunctivitis Treatment Gains USFDA Approval

Written by : Varsha Sharma

December 29, 2023

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Lupin secures USFDA approval for its Loteprednol Etabonate Ophthalmic Suspension, 0.2%, a generic equivalent to Alrex, addressing seasonal allergic conjunctivitis. Annual sales are estimated at USD 29.1 million in the U.S. (IQVIA MAT October 2023).

Global pharmaceutical giant Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Suspension, 0.2%.

The approval allows Lupin to market a generic equivalent to the reference listed drug (RLD) Alrex Ophthalmic Suspension, 0.2%, originally developed by Bausch & Lomb Inc.

The manufacturing will take place at Lupin’s Pithampur facility in India. Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. The product, known as RLD Alrex, had estimated annual sales of USD 29.1 million in the U.S. according to IQVIA MAT data from October 2023.

Founded in 1968, the Indian multinational pharmaceutical company offers a diverse portfolio of branded and generic formulations, biotechnology products, and APIs. Headquartered in Mumbai, the company specialises in the development and commercialisation of a wide range of branded and generic formulations, biotechnology products, and APIs (Active Pharmaceutical Ingredients).

Currently, Lupin serves over 100 markets spanning the US, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. Lupin's key focus areas include paediatrics, cardiovascular, anti-infectives, diabetology, asthma and anti-tuberculosis.

Lupin had previously unveiled plans to broaden its market presence, particularly in Europe and Canada. The Mumbai-based pharmaceutical giant aimed to acquire two renowned brands, AARANE™ in Germany and NALCROM™ in Canada and the Netherlands, from French pharmaceutical company Sanofi Pharmaceuticals.

The acquisition, valued at INR 91 Cr (approximately EUR 10 million), with an additional contingent amount of up to INR 72.8 Cr based on future sales milestones, was expected to be completed in the first quarter of 2024. Lupin Atlantis Holdings SA Switzerland (LAHSA), a wholly-owned subsidiary of Lupin, was set to acquire the portfolio.

According to the disclosure filed on the Bombay Stock Exchange (BSE), the revenue generated from these products in the relevant markets during FY23 amounted to $6.494 million (INR 53.7 Cr). Lupin aimed to introduce these established assets in the respiratory field, contributing to the development of its new respiratory franchise in Europe and Canada. 


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