#United States #Upsher-Smith #Maple Grove #Restasis #Cyclosporine

Upsher-Smith Laboratories Launches Generic Restasis®

On May 20, 2026, Upsher-Smith Laboratories, LLC, a subsidiary of Bora Pharmaceuticals Co., Ltd., announced the introduction of a generic formulation of Cyclosporine Ophthalmic Emulsion at a strength of 0.05%, which is therapeutically equivalent to Restasis®. This FDA-approved product aims to provide a more affordable option for patients needing treatment for dry eye disease.

Market Significance

The launch comes at a time when the cyclosporine ophthalmic emulsion market is estimated to have had U.S. sales amounting to approximately $1.9 billion, according to IQVIA. From fulfilling the needs of patients to easing the financial burden of medications, this new generic option is poised to make a considerable impact in the market.

Jim Maahs, Senior Vice President and Head of Upsher-Smith Commercial, stated that the release of this product highlights the company's ongoing commitment to expanding its U.S. portfolio. He noted, “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 Details

The new product is available in two package sizes:

• - Cyclosporine Ophthalmic Emulsion 0.05%

- NDC #24979-126-19, packaged in 30-count 0.4 mL vials.
- NDC #24979-126-18, packaged in 60-count 0.4 mL vials.

These vials are single-use, ensuring safety and hygiene, as patients are instructed to discard them after each application. Customers looking to place orders can contact Upsher-Smith at 1-800-654-2299 for more information.

Commitment to Quality Healthcare

Upsher-Smith has long been recognized as a trusted name in the U.S. pharmaceutical landscape, dedicated to enhancing the lives of patients through high-quality products and sustainable growth. The company prides itself on its ability to offer both generic and brand medications, maintaining a strong focus on service, industry relations, and ensuring a consistent supply chain.

In addition to this launch, Bora Pharmaceuticals continues to broaden its Research and Development and sales infrastructure, particularly focusing on niche and rare diseases. By investing in the talent and operational capabilities, they aspire to fulfill their vision of “Contributing to Better Health All Over the World.”

The recent approval from the FDA for this abbreviated new drug application (ANDA) was received in January 2026, making the product available for those who need it since May 2026.

Conclusion

The introduction of the generic version of Restasis by Upsher-Smith not only diversifies the range of ophthalmic products available but also signals a positive shift in the market towards affordability and accessibility in healthcare. As more patients gain access to this vital medication, we look forward to seeing how it will influence the treatment landscape for dry eye conditions. For further details about the product or to view the full prescribing information, visit Upsher-Smith's website. Report any potential adverse reactions to Upsher-Smith Laboratories at 1-855-899-9180 or to the FDA via Medwatch.