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UPSHER-SMITH LAUNCHES GENERIC VERSION OF RESTASIS® (CYCLOSPORINE OPHTHALMIC EMULSION 0.05%)

2026-05-20 10:00 ET - News Release

UPSHER-SMITH LAUNCHES GENERIC VERSION OF RESTASIS® (CYCLOSPORINE OPHTHALMIC EMULSION 0.05%)

PR Newswire

MAPLE GROVE, Minn., May 20, 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 Cyclosporine Ophthalmic Emulsion 0.05%, therapeutically equivalent to the Reference Listed Drug (RLD), RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%. According to IQVIA, the cyclosporine ophthalmic emulsion market had U.S. sales of approximately $1.9 billion*. Bora received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for the product in January 2026.

"The launch of cyclosporine ophthalmic emulsion reflects Upsher-Smith's continued momentum in expanding and diversifying its U.S. portfolio," said Jim Maahs, Senior Vice President, Head of Upsher-Smith Commercial. "This addition strengthens our ophthalmic offerings and reflects our focus on bringing medicines to market that support the evolving needs of our customers, healthcare providers and patients."

Product Information

   
        
          Product        Strength          NDC #      Package Size


 
   Cyclosporine Ophthalmic Emulsion   0.05 % 24979-126-19   0.4 mL vials

                                                                30-count


 
   Cyclosporine Ophthalmic Emulsion   0.05 % 24979-126-18   0.4 mL vials

                                                                60-count

These are single-use vials and should be discarded after each use.
For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

Please refer to the full Prescribing Information for Cyclosporine Ophthalmic Emulsionhere. 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.

*February 2025 - January 2026.
**Restasis is a registered trademark of AbbVie Inc.

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SOURCE Upsher-Smith Laboratories, LLC

Contact:

Elizabeth Likly, Kovak-Likly Communications, 203-762-8833, elikly@klcpr.com

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