Lupin Limited announced that the FDA has approved its abbreviated new drug application (ANDA) for bromfenac ophthalmic solution 0.09%, enabling the Mumbai-based pharmaceutical company to market a generic equivalent of Bausch + Lomb's Bromday ophthalmic solution in the United States. The approval represents entry into an estimated $11 million annual US market, according to IQVIA MAT data for June.
Clinical Application and Dosing
As a topical nonsteroidal anti-inflammatory drug (NSAID), bromfenac ophthalmic solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain following cataract surgery. The approved dosing regimen requires one drop of the solution to be applied to the affected eye(s) once daily starting one day prior to surgery, continuing on the day of surgery, and through the first 14 days following surgery.
Manufacturing and Market Position
The generic product will be manufactured at Lupin's facility in Pithampur, India. Lupin Limited, headquartered in Mumbai with a US subsidiary in Baltimore, Maryland, is a multinational generic pharmaceutical company that develops and commercializes branded and generic formulations, biotechnology products, and active pharmaceutical ingredients across multiple therapeutic areas including pediatrics, cardiovascular, anti-infective, diabetes, asthma, and anti-tuberculosis treatments.
Regulatory Pathway and Bioequivalence
The ANDA approval process enabled Lupin to demonstrate bioequivalence without conducting costly clinical trials that had already been performed for the brand-name drug. According to FDA requirements, the company tested the drug on a small group of patients to prove it could reach the intended site of action at the same time and in the same concentration as the brand-name drug, delivering the same amount of active ingredients in a patient's bloodstream within the same timeframe.
Competitive Landscape
Bromfenac ophthalmic solution serves as a reference-listed drug (RLD) that generic manufacturers can reference when filing ANDAs. Several companies have previously received approval to market bromfenac in varying concentrations, including Bausch + Lomb's Bromday (0.09%) and Prolensa (0.07%), ISTA Pharmaceuticals' Xibrom (0.09%), and Sun Pharmaceutical Industries' BromSite (0.075%). Notably, Bromday was discontinued between 2012 and 2013 upon Prolensa's launch, while Xibrom was discontinued in 2011 before ISTA Pharmaceuticals was acquired by Bausch + Lomb in 2012.
