Cosette Pharmaceuticals said the U.S. Food and Drug Administration has approved its abbreviated new drug application for the first generic version of CIPRO HC, granting the company 180 days of Competitive Generic Therapy exclusivity and ending a more than 27-year stretch without a generic alternative.
Commercial shipments have already begun, triggering the exclusivity period.
The generic ear-infection treatment, a ciprofloxacin 0.2% and hydrocortisone 1% otic suspension, is a clinically equivalent and more affordable option for patients with acute otitis externa.
U.S. sales of the branded product totaled roughly $17.9 million in the 12 months ending September 2025, according to IQVIA.
Cosette CEO Apurva Saraf said the approval marks the fourth CGT launch for the company within three years, underscoring its expanding R&D and operational capabilities.
The drug will be manufactured at Cosette’s Lincolnton, North Carolina facility, which supports a pipeline aimed at addressing gaps in treatment availability.
The CGT pathway, created to encourage development of generics for drugs with limited competition, provides six months of market exclusivity to the first approved applicant.
Cosette’s launch positions it to capture the full generic market for CIPRO HC during that window before broader competition enters.