Cosette Pharmaceuticals Announces the Approval and Launch of First Generic Version of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), with 180 days Competitive Generic Therapy (CGT) exclusivity

Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Cosette's Abbreviated New Drug Application (ANDA) for the first generic version of CIPRO^® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), with 180 days of Competitive Generic Therapy (CGT) exclusivity. Cosette has commenced commercial shipments, triggering the 180 days of market exclusivity.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216065234/en/

As the first approved generic of CIPRO^® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension) in more than 27 years, this launch provides patients and healthcare providers with a clinically equivalent, more affordable treatment option for 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 registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG.

See Package Insert (PI) for full prescribing information including Safety Information here.

About Cosette Pharmaceuticals

Cosette Pharmaceuticals, Inc. is a U.S.-based, fully integrated pharmaceutical company with a fast-growing portfolio of products in women's health and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 350+ dedicated team members across all functional areas. Cosette is backed by Avista Healthcare Partners, a healthcare focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm (NASDAQ:HLNE). For more information, please visit www.cosettepharma.com or follow Cosette on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251216065234/en/

Cosette Pharmaceuticals:

Media:

[email protected]