BRIDGEWATER, N.J. — Cosette Pharmaceuticals, Inc. said the U.S. Food and Drug Administration has approved the company’s Abbreviated New Drug Application for the first generic version of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), granting 180 days of Competitive Generic Therapy exclusivity.
The company said it has begun commercial shipments of the product, triggering the 180-day market exclusivity period. The approval marks the first generic version of CIPRO HC to reach the U.S. market in more than 27 years, providing a lower-cost, clinically equivalent treatment option for patients with acute otitis externa.
“We are proud to deliver the first approved generic version of this important therapy under the FDA’s Competitive Generic Therapy pathway,” said Apurva Saraf, President and CEO of Cosette Pharma. “This is Cosette’s fourth CGT approval and launch in the last three years, demonstrating our strong R&D and operational capabilities, and our unwavering commitment to expanding patient access to needed medicines. We will manufacture this product at our state-of-the-art manufacturing facility in Lincolnton, North Carolina, and will continue to advance our pipeline to address critical gaps in treatment availability for patients.”
According to IQVIA, U.S. annual sales of CIPRO HC for the 12 months ending September 2025 were approximately $17.9 million.
CIPRO is a registered trademark of Bayer Intellectual Property GmbH and is licensed to Alcon by Bayer Intellectual Property AG.
