UPSHER-SMITH LAUNCHES GENERIC VERSION OF CIPRODEX® (CIPROFLOXACIN 0.3% AND DEXAMETHASONE 0.1%) STERILE OTIC SUSPENSION

Q: When did Upsher-Smith launch the generic Ciprofloxacin 0.3%/Dexamethasone 0.1% otic suspension (BORAY)?

Upsher-Smith launched the generic otic suspension on April 6, 2026 . According to Upsher-Smith, the product introduction is part of its diversification strategy and includes NDC 0832-1430-75 in a 7.5 mL package.

Q: What is the therapeutic equivalence code for Upsher-Smith's Ciprofloxacin/Dexamethasone otic suspension (BORAY)?

The product carries a TE code AB , indicating pharmaceutical equivalence and bioequivalence. According to Upsher-Smith, that AB rating aligns the generic with the reference listed drug Ciprodex for substitutability.

Q: How large is the U.S. market for Ciprofloxacin and Dexamethasone otic suspension that BORAY entered?

IQVIA reports U.S. sales of approximately $118 million for the Ciprofloxacin and Dexamethasone otic suspension market. According to Upsher-Smith, this figure frames the commercial opportunity for the new generic.

Q: How can pharmacies or clinicians order Upsher-Smith's Ciprofloxacin/Dexamethasone otic suspension (BORAY)?

Order inquiries can be directed to Upsher-Smith at 1-800-654-2299 . According to Upsher-Smith, customers may also request full prescribing information via 1-888-650-3789 .

Rhea-AI Impact

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Rhea-AI Sentiment

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Rhea-AI Summary

Bora Pharmaceuticals (BORAY) subsidiary Upsher-Smith launched a generic Ciprofloxacin 0.3% / Dexamethasone 0.1% Otic Suspension (NDC 0832-1430-75, 7.5 mL) on April 6, 2026. The product carries an AB therapeutic equivalence code and lists the brand Ciprodex as the reference listed drug.

According to the company, IQVIA reports U.S. market sales for this combination at approximately $118 million, and Upsher-Smith positions the launch as part of a portfolio diversification strategy.

Positive

First prescription ear drop suspension launch for Upsher-Smith
Market size cited at approximately $118 million (IQVIA)
Therapeutic equivalence AB designation to Ciprodex supports substitutability

Negative

No company sales guidance or revenue projections included with the launch announcement

AI-generated analysis. How Rhea-AI works. Not financial advice.

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04/06/2026 - 02:01 PM

First Prescription Ear Drop Suspension Advances Portfolio Diversification Strategy

MAPLE GROVE, Minn., April 6, 2026 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith), a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX) today announced the recent launch of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP. According to IQVIA, the Ciprofloxacin and Dexamethasone Otic Suspension market had U.S. sales of approximately $118 million*.

"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, Head of Upsher-Smith Commercial. "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."

The Therapeutic Equivalence (TE) code for Upsher-Smith's Ciprofloxacin and Dexamethasone Otic Suspension product is AB, and the Reference Listed Drug (RLD) is the brand Ciprodex^®**.

Product Information

Product	Strength	NDC #	Package Size
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP	0.3%/0.1%	0832-1430-75	7.5 mL

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

Please refer to the full Prescribing Information for Ciprofloxacin and Dexamethasone Otic Suspension here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.

About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

About Bora
Founded in 2007, Bora Pharmaceuticals ("Bora" or "the Company", 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of "Contributing to Better Health All Over the World". Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.

By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries. For more, please visit: https://www.bora-corp.com and https://www.boracdmo.com.

*December 2024 through November 2025.
**Ciprodex is a registered trademark of Bayer AG.

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SOURCE Upsher-Smith Laboratories, LLC

FAQ

When did Upsher-Smith launch the generic Ciprofloxacin 0.3%/Dexamethasone 0.1% otic suspension (BORAY)?

Upsher-Smith launched the generic otic suspension on April 6, 2026. According to Upsher-Smith, the product introduction is part of its diversification strategy and includes NDC 0832-1430-75 in a 7.5 mL package.

What is the therapeutic equivalence code for Upsher-Smith's Ciprofloxacin/Dexamethasone otic suspension (BORAY)?

The product carries a TE code AB, indicating pharmaceutical equivalence and bioequivalence. According to Upsher-Smith, that AB rating aligns the generic with the reference listed drug Ciprodex for substitutability.

How large is the U.S. market for Ciprofloxacin and Dexamethasone otic suspension that BORAY entered?

IQVIA reports U.S. sales of approximately $118 million for the Ciprofloxacin and Dexamethasone otic suspension market. According to Upsher-Smith, this figure frames the commercial opportunity for the new generic.

How can pharmacies or clinicians order Upsher-Smith's Ciprofloxacin/Dexamethasone otic suspension (BORAY)?

Order inquiries can be directed to Upsher-Smith at 1-800-654-2299. According to Upsher-Smith, customers may also request full prescribing information via 1-888-650-3789.

What does the BORAY launch of this generic otic suspension mean for shareholders?

The launch adds a differentiated dosage form to Upsher-Smith's portfolio, which may support diversification. According to Upsher-Smith, no sales guidance or financial impact figures were provided with the announcement.