Lupin gets U.S. FDA nod for Loteprednol Etabonate Ophthalmic Gel
The approved product is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for the product and consequently eligible for 180 days of generic drug exclusivity. The product will be manufactured at its Pithampur facility, the company said.
Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of $29 million in the U.S., it said citing IQVIA MAT May 2025 numbers. A corticosteroid, the drug is indicated for treatment of postoperative inflammation and pain following ocular surgery.
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Business Standard
a day ago
- Business Standard
Lupin gets USFDA nod for Loteprednol Etabonate Ophthalmic Gel
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%. The product is a generic equivalent of Lotemax SM Ophthalmic Gel, 0.38%, marketed by Bausch & Lomb Inc. Lupin is the exclusive first-to-file applicant for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins 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. According to IQVIA MAT data for May 2025, Loteprednol Etabonate Ophthalmic Gel, 0.38% (Reference Listed Drug: Lotemax SM) had estimated annual sales of $29 million in the U.S. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.85% to Rs 1,978.05 on the BSE.
The Hindu
2 days ago
- The Hindu
Lupin gets U.S. FDA nod for Loteprednol Etabonate Ophthalmic Gel
Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug application for Loteprednol Etabonate Ophthalmic Gel, 0.38% The approved product is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for the product and consequently eligible for 180 days of generic drug exclusivity. The product will be manufactured at its Pithampur facility, the company said. Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of $29 million in the U.S., it said citing IQVIA MAT May 2025 numbers. A corticosteroid, the drug is indicated for treatment of postoperative inflammation and pain following ocular surgery.
Business Standard
2 days ago
- Business Standard
Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
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).
