Upsher-Smith Launches Generic Ciprodex® Ear Drop

MAPLE GROVE, MN – April 06, 2026 – Upsher-Smith Laboratories, LLC, a subsidiary of Bora Pharmaceuticals, has announced the launch of its Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP. The product is a therapeutically equivalent generic version of the widely prescribed brand-name drug Ciprodex®, used to treat common bacterial ear infections. This launch marks the company's entry into the prescription otic suspension market, a segment with U.S. sales of approximately $118 million over the past year.

A More Affordable Option for Common Ear Ailments

The new generic from Upsher-Smith offers a more affordable alternative for treating two prevalent types of ear infections: acute otitis media (middle ear infection) in children with tympanostomy tubes and acute otitis externa (often called "swimmer's ear") in both children and adults. The medication combines ciprofloxacin, a powerful antibiotic that fights bacteria, with dexamethasone, a corticosteroid that reduces the inflammation, swelling, and pain associated with these infections.

For patients and their families, the availability of another generic competitor can translate directly into significant cost savings. While a 7.5 mL bottle of brand-name Ciprodex® can cost upwards of $300 without insurance, existing generic versions have already brought the price down substantially, with some discount programs offering the treatment for as low as $55. The introduction of Upsher-Smith's product is expected to intensify price competition, further enhancing affordability and access for patients who might otherwise struggle with the cost of treatment.

The U.S. Food and Drug Administration (FDA) has assigned Upsher-Smith's product a Therapeutic Equivalence (TE) code of "AB." This designation confirms that the generic is bioequivalent to the brand-name drug, meaning it has the same active ingredients, strength, dosage form, and route of administration, and is expected to have the same clinical effect and safety profile. This assurance allows pharmacists to substitute the generic for the brand with confidence, and for physicians to prescribe it knowing their patients will receive an effective and high-quality treatment.

A Strategic Move to Diversify and Compete

While the patient benefits are clear, this launch also represents a significant strategic milestone for Upsher-Smith. The Ciprofloxacin and Dexamethasone Otic Suspension is the company's first prescription ear drop, signaling a deliberate expansion into new dosage forms and therapeutic areas.

"The introduction of Upsher-Smith's first prescription ear drop suspension reinforces our strategic focus on expanding and diversifying our generics portfolio to support sustainable, long-term growth," said Jim Maahs, Senior Vice President and Head of Upsher-Smith Commercial, in the company's announcement. "By adding Ciprofloxacin and Dexamethasone Otic Suspension, we continue to strengthen our presence in differentiated dosage forms while delivering options that meet the needs of our customers and the patients they serve."

Upsher-Smith enters a market where generic competition already exists. Dr. Reddy's Laboratories launched its version of the ear drop in August 2020, and other manufacturers like Sun Pharmaceutical Industries are also present. However, Upsher-Smith's entry is part of a broader, consistent pattern of portfolio diversification. In recent years, the company has expanded into ophthalmics with products like Difluprednate Ophthalmic Emulsion and a generic version of Combigan®, as well as into the rare disease space with the launches of Kymbee™ and Torpenz™. This latest move into otic medications underscores a clear corporate strategy to build a robust and varied portfolio of generic and branded products.

Part of a Broader U.S. Expansion by Bora Pharmaceuticals

The strategic direction of Upsher-Smith is deeply intertwined with the ambitions of its parent company, Taiwan-based Bora Pharmaceuticals Co., Ltd. Bora acquired Upsher-Smith in April 2024, a landmark deal that provided the global pharmaceutical services company with a significant manufacturing and commercial foothold in the United States.

Bora operates on a "Dual-Engine" model, which integrates its global contract development and manufacturing organization (CDMO) services with a commercial specialty pharmaceuticals business. The acquisition of Upsher-Smith, with its portfolio of nearly 50 generic products and established sales infrastructure, is central to the commercial side of this engine. This launch exemplifies how Bora is leveraging its subsidiary to penetrate the U.S. generics market more deeply.

The move aligns with Bora's stated goal of using its unified CDMO network to improve the cost-competitiveness of Upsher-Smith's generics portfolio. The company has been aggressively investing in its U.S. capabilities, including the recent acquisition of a sterile manufacturing facility in Baltimore, Maryland. These investments are designed to support launches like the Ciprofloxacin and Dexamethasone Otic Suspension and accelerate Bora's growth in the world's largest pharmaceutical market.

The Impact of Generics on the Otic Market Landscape

The story of Ciprofloxacin and Dexamethasone Otic Suspension is a case study in the evolution of a drug market after patent expiry. When the first generic version was launched in 2020, the annual U.S. sales for the brand-name drug and its equivalents were approximately $453 million. Today, that market is valued at around $118 million. This dramatic reduction in market value highlights the powerful deflationary effect that generic competition has on drug prices.

While this shift significantly reduces revenue for the original brand manufacturer, it generates substantial savings for the healthcare system, including insurers, government programs like Medicare, and patients paying out-of-pocket. The entry of additional competitors like Upsher-Smith ensures a more stable supply chain and sustains the downward pressure on prices, making essential medications more accessible.

This launch was also made possible by Upsher-Smith's investment in its own manufacturing infrastructure. The company opened a new, state-of-the-art facility in Maple Grove, Minnesota, in February 2023, which is equipped to handle various dosage forms, including the liquids and suspensions required for otic products. By building out these capabilities, the company is positioning itself to continue its strategic diversification and compete effectively across multiple segments of the pharmaceutical industry.