Lupin rolls out Loteprednol Etabonate Ophthalmic Suspension, 0.5% in US
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-07-16 11:34 GMT | Update On 2025-07-16 11:34 GMT
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Mumbai: Global pharma major Lupin Limited has launched Loteprednol Etabonate Ophthalmic Suspension, 0.5%, in the United States, following United States Food and Drug Administration (USFDA) approval last year.
The product is bioequivalent to Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc.
Loteprednol Etabonate Ophthalmic Suspension, 0.5% is indicated for the treatment of steroidresponsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. It is also indicated for the treatment of post-operative inflammation following ocular surgery.
Loteprednol Etabonate Ophthalmic Suspension (RLD Lotemax) had estimated annual sales of USD 55 million in the U.S. (IQVIA MAT May 2025).
This launch strengthens Lupin's presence in the U.S. ophthalmic space. The company also received USFDA approval for Loteprednol Etabonate Ophthalmic Gel, 0.38%, earlier this month.
In December 2023, Lupin received approval from the USFDA for Loteprednol Etabonate Ophthalmic Suspension, 0.2%.
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. The company has 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.
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