Cosette Pharmaceuticals Launches First Generic CIPRO HC with 180-Day Market Exclusivity
Key Insights
Cosette Pharmaceuticals (search) received FDA approval for the first generic version of CIPRO HC otic suspension in over 27 years, securing 180 days of competitive generic therapy exclusivity.
The generic ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension provides a more affordable treatment option for acute otitis externa (search) patients.
This marks Cosette's fourth CGT approval in three years, with the product manufactured at their North Carolina facility targeting a $17.9 million annual market.
Cosette Pharmaceuticals (search) has achieved a significant milestone in expanding access to ear infection treatments with the FDA approval and commercial launch of 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, marking the first generic alternative to this treatment in more than 27 years.
Market Impact and Exclusivity
The company has commenced commercial shipments, triggering the 180-day market exclusivity period under the FDA's Competitive Generic Therapy pathway. According to IQVIA data, U.S. annual sales of CIPRO HC for the 12 months ending September 2025 were approximately $17.9 million, representing the market opportunity for this newly launched generic product.
This launch provides patients and healthcare providers with a clinically equivalent, more affordable treatment option for acute otitis externa (search), addressing a critical need in the ear infection treatment landscape.
Company Leadership and Strategic Vision
"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."
Manufacturing and Operations
Cosette will manufacture the generic CIPRO HC at their state-of-the-art manufacturing facility in Lincolnton, North Carolina. The company maintains corporate and manufacturing facilities in New Jersey and North Carolina, supported by over 350 dedicated team members across all functional areas.
The approval represents part of Cosette's broader strategy to advance their pipeline and address critical gaps in treatment availability for patients. The company specializes in complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, with a focus on women's health and dermatology products.
Regulatory and Trademark Information
The original CIPRO is a registered trademark of Bayer Intellectual Property GmbH (search), licensed to Alcon by Bayer Intellectual Property AG. Cosette's generic version received approval through the Abbreviated New Drug Application (ANDA) pathway, demonstrating bioequivalence to the reference product.
Cosette Pharmaceuticals (search) is backed by Avista Healthcare Partners, a healthcare-focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm.