Cosette Pharmaceuticals, a US-based, fully integrated pharmaceutical company, has announced that the USFDA has approved its Abbreviated New Drug Application (ANDA) for the first generic version of CIPRO HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension). 

 

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity, and Cosette has already begun commercial shipments, activating the exclusivity period.

 

This marks the first approved generic of CIPRO HC in more than 27 years, offering patients and healthcare providers a clinically equivalent, more affordable option for treating 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 totaled approximately $17.9 million. CIPRO is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG.