What is the U.S. market size for cyclosporine ophthalmic emulsion related to Bora (BORAY)?

The U.S. cyclosporine ophthalmic emulsion market is about $1.9 billion in sales. According to Upsher-Smith, citing IQVIA data, this figure reflects total U.S. sales for the category, providing context for its generic Restasis-equivalent launch.

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

Q: What product did Upsher-Smith and Bora Pharmaceuticals (BORAY) launch on May 20, 2026?

Upsher-Smith launched Cyclosporine Ophthalmic Emulsion 0.05% , a generic version therapeutically equivalent to Restasis . According to Upsher-Smith, this ophthalmic product broadens its U.S. portfolio and supports patients, healthcare providers, and customers needing cyclosporine eye treatment options.

Q: When did Bora Pharmaceuticals (BORAY) receive FDA approval for its generic Restasis eye drops?

Bora received FDA approval of its ANDA for Cyclosporine Ophthalmic Emulsion 0.05% in January 2026 . According to Upsher-Smith, this abbreviated new drug application approval enabled the subsequent U.S. launch of the therapeutically equivalent generic ophthalmic emulsion.

Q: How can healthcare providers order Cyclosporine Ophthalmic Emulsion 0.05% from Upsher-Smith?

Healthcare providers can order by calling Upsher-Smith at 1-800-654-2299 . According to Upsher-Smith, additional product information, including full Prescribing Information, can be requested via 1-888-650-3789, supporting informed prescribing and pharmacy ordering decisions.

Q: How can adverse reactions to Upsher-Smith’s Cyclosporine Ophthalmic Emulsion 0.05% be reported?

Adverse reactions can be reported to Upsher-Smith at 1-855-899-9180 or directly to the FDA. According to Upsher-Smith, FDA reports can be submitted through the MedWatch program at the official website, supporting post-marketing safety monitoring for the product.

Rhea-AI Impact

(High)

Rhea-AI Sentiment

(Positive)

Rhea-AI Summary

Upsher-Smith, a subsidiary of Bora Pharmaceuticals (OTCQX:BORAY), launched Cyclosporine Ophthalmic Emulsion 0.05%, a generic version therapeutically equivalent to Restasis. Bora received FDA ANDA approval in January 2026. According to IQVIA, the U.S. cyclosporine ophthalmic emulsion market totals about $1.9 billion.

The product is offered in 0.4 mL single-use vials in 30- and 60-count packages.

AI-generated analysis. Not financial advice.

Positive

Launch of FDA-approved generic cyclosporine ophthalmic emulsion 0.05% in U.S.
Targets U.S. cyclosporine ophthalmic emulsion market of approximately $1.9 billion
Expands and diversifies Upsher-Smith’s U.S. ophthalmic product portfolio
Two package sizes offered: 30-count and 60-count 0.4 mL single-use vials

Negative

None.

05/20/2026 - 10:00 AM

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 Emulsion 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.

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

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SOURCE Upsher-Smith Laboratories, LLC

FAQ

What product did Upsher-Smith and Bora Pharmaceuticals (BORAY) launch on May 20, 2026?

Upsher-Smith launched Cyclosporine Ophthalmic Emulsion 0.05%, a generic version therapeutically equivalent to Restasis. According to Upsher-Smith, this ophthalmic product broadens its U.S. portfolio and supports patients, healthcare providers, and customers needing cyclosporine eye treatment options.

Is Upsher-Smith’s Cyclosporine Ophthalmic Emulsion 0.05% therapeutically equivalent to Restasis?

Yes, Upsher-Smith’s Cyclosporine Ophthalmic Emulsion 0.05% is described as therapeutically equivalent to Restasis. According to Upsher-Smith, the product matches the Reference Listed Drug (RLD) cyclosporine ophthalmic emulsion 0.05% in therapeutic effect for indicated patients.

When did Bora Pharmaceuticals (BORAY) receive FDA approval for its generic Restasis eye drops?

Bora received FDA approval of its ANDA for Cyclosporine Ophthalmic Emulsion 0.05% in January 2026. According to Upsher-Smith, this abbreviated new drug application approval enabled the subsequent U.S. launch of the therapeutically equivalent generic ophthalmic emulsion.

In what package sizes is Upsher-Smith’s Cyclosporine Ophthalmic Emulsion 0.05% available?

The product is available as 0.4 mL single-use vials in 30- and 60-count packages. According to Upsher-Smith, National Drug Codes are 24979-126-19 for 30-count and 24979-126-18 for 60-count, and each vial should be discarded after use.

How can healthcare providers order Cyclosporine Ophthalmic Emulsion 0.05% from Upsher-Smith?

Healthcare providers can order by calling Upsher-Smith at 1-800-654-2299. According to Upsher-Smith, additional product information, including full Prescribing Information, can be requested via 1-888-650-3789, supporting informed prescribing and pharmacy ordering decisions.

How can adverse reactions to Upsher-Smith’s Cyclosporine Ophthalmic Emulsion 0.05% be reported?

Adverse reactions can be reported to Upsher-Smith at 1-855-899-9180 or directly to the FDA. According to Upsher-Smith, FDA reports can be submitted through the MedWatch program at the official website, supporting post-marketing safety monitoring for the product.