• 19 Dec 2025
• Admin
• News Article

Cosette Pharma Wins FDA Approval for First Generic Cipro HC, Secures 180-Day Market Exclusivity

Cosette Pharmaceuticals has added another milestone to its generics portfolio with the US FDA approving 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 in the US.

A Long-Awaited Generic Option for Otitis Externa

This launch marks the first FDA-approved generic of Cipro HC in more than 27 years, offering a clinically equivalent and more affordable treatment option for patients with acute otitis externa, commonly known as swimmer’s ear.

For healthcare providers and patients, the approval helps ease long-standing cost and access challenges associated with the branded product.

CGT Pathway Highlights Cosette’s Execution Strength

The approval represents Cosette’s fourth CGT launch in the past three years, reinforcing the company’s growing expertise in navigating complex regulatory pathways and delivering first-to-market generics.

According to Apurva Saraf, President and CEO of Cosette Pharmaceuticals, the approval reflects the company’s strong R&D and operational foundation, as well as its commitment to expanding access to essential medicines. The product will be manufactured at Cosette’s state-of-the-art facility in Lincolnton, North Carolina.

Market Opportunity and Commercial Impact

• US annual sales of Cipro HC reached approximately $17.9 million in the 12 months ending September 2025, according to IQVIA
• The 180-day exclusivity period positions Cosette to capture significant early market share
• The launch strengthens Cosette’s presence in complex dosage forms, including otic suspensions

Strengthening a Growing Generics Portfolio

Cosette Pharmaceuticals continues to build a fast-growing portfolio across women’s health and dermatology, supported by integrated manufacturing capabilities in New Jersey and North Carolina and a workforce of over 350 employees.

With this approval, Cosette further cements its role as a reliable supplier of complex, high-value generics that address gaps in patient access across the US healthcare system.

Bottom line: The FDA approval of the first generic Cipro HC not only delivers a long-overdue alternative for patients but also underscores Cosette’s momentum in executing high-impact generic launches through the CGT pathway.