Lupin Receives Approval from U.S. FDA for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
Mumbai, Naples, July 1, 2025: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%. Loteprednol Etabonate Ophthalmic Gel, 0.38% is bioequivalent to Lotemax® SM Ophthalmic Gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax® SM) had an estimated annual sale of USD 29 million in the U.S. (IQVIA MAT May 2025).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries please contact –
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
*Safe Harbor Statement
Lotemax® is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
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