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 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
An Abbreviated New Drug Application (ANDA) is the regulatory request a company files to get approval to market a generic version of an existing prescription drug by showing it has the same active ingredient, strength, dosage form and works the same in the body without repeating full clinical trials. Think of it as proving your copy of a recipe tastes and performs the same as the original. For investors, ANDA approvals determine whether a lower‑cost competitor can enter a market, affecting sales, pricing, patent disputes and the value of both the original drug maker and the generic entrant.
competitive generic therapy (cgt)regulatory
Competitive generic therapy (CGT) is a regulatory label given to a drug product when there is little or no effective generic competition for an approved brand-name medication; it speeds review and approval of a generic version to address unmet demand. For investors, CGT status matters because it can let a company bring a lower-cost alternative to market faster — like being first in line when a store has no substitutes — which can quickly reduce the original drug's sales or create a profitable niche for the generic maker.
otic suspensionmedical
An otic suspension is a liquid medicine made for ear use in which tiny solid particles of active drug are evenly dispersed but not dissolved, like fine sand floating in water that must often be shaken before use. Investors should care because this formulation affects manufacturing steps, shelf life, dosing reliability, regulatory scrutiny and patient convenience—factors that influence development costs, approval timelines, market acceptance and recurring sales.
acute otitis externamedical
An infection or inflammation of the ear canal, often called “swimmer’s ear,” that causes pain, redness, itching and sometimes discharge when the outer ear becomes irritated or infected. Investors care because its frequency, severity and standard treatments influence demand for prescription medicines, over‑the‑counter products, medical visits and device solutions; changes in treatment options, clinical results or approvals can affect sales, costs and valuation for healthcare companies tied to ear care.
u.s. food and drug administration (fda)regulatory
The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.
package insert (pi)regulatory
A package insert (PI) is the official document that comes with a prescription drug, listing what the product is approved to treat, how to use it, risks and side effects, dosing, and key clinical trial findings. Think of it as the drug’s instruction manual and safety label; changes to the PI—such as new warnings, removed indications, or updated effectiveness data—can influence prescribing, sales, legal risk, and regulatory standing, so investors watch it for signals about a medicine’s commercial and regulatory prospects.
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BRIDGEWATER, N.J.--(BUSINESS WIRE)--
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.
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.
