EYSUVIS: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933	NDA	ALCON LABORATORIES, INC.	71571-333-01	1 BOTTLE, DROPPER in 1 CARTON (71571-333-01) / 1 mL in 1 BOTTLE, DROPPER	2020-11-18
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933	NDA	ALCON LABORATORIES, INC.	71571-333-24	2.4 mL in 1 BOTTLE, DROPPER (71571-333-24)	2020-11-18
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933	NDA	ALCON LABORATORIES, INC.	71571-333-83	1 BOTTLE, DROPPER in 1 CARTON (71571-333-83) / 8.3 mL in 1 BOTTLE, DROPPER	2020-11-18
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

EYSUVIS (loteprednol etabonate ophthalmic suspension) is a corticosteroid medication approved by the U.S. Food and Drug Administration (FDA) in 2020 for the treatment of dry eye disease (DED). As a prescription topical eye drop, EYSUVIS addresses the inflammatory component of dry eye, offering an alternative to existing therapies. The procurement and supply chain management of EYSUVIS are critical for pharmaceutical companies, healthcare providers, and distributors seeking consistent, high-quality sources of this specialized drug. This article delineates the primary suppliers involved in the manufacturing and distribution of EYSUVIS, the expected market dynamics, and strategic considerations for stakeholders.

Manufacturers and Licensing

EYSUVIS is developed and marketed by Kala Pharmaceuticals, a biotechnology company specializing in ocular diseases. Following FDA approval, Kala Pharmaceuticals holds the rights to manufacture and distribute EYSUVIS. As a proprietary formulation, EYSUVIS's manufacturing involves complex processes that necessitate specialized facilities compliant with Good Manufacturing Practices (GMP).

Although Kala Pharmaceuticals is the primary entity responsible for the drug's production, they may partner with Contract Manufacturing Organizations (CMOs) to scale up production and ensure supply chain resilience. CMOs such as Almac Group, Lonza, or Catalent are commonly engaged within the pharmaceutical industry for small-molecule and ophthalmic drug manufacturing. These partnerships enable Kala Pharmaceuticals to meet the increasing demand and to maintain high-quality standards.

Key Point: Currently, Kala Pharmaceuticals is the sole manufacturer of EYSUVIS, with potential collaborations with CMOs to augment manufacturing capacity.

Distribution Channels and Supply Chain

Post-manufacture, EYSUVIS is distributed through a network of wholesalers, specialty pharmacy chains, and hospital pharmacies across the United States. Wholesale distributors such as McKesson, AmerisourceBergen, and Cardinal Health typically serve as intermediaries.

The supply chain is influenced by various factors:

Regulatory compliance: Ensuring adherence to FDA and GMP standards during packaging and distribution.
Inventory management: Maintaining appropriate stock levels to prevent shortages without overstocking.
Distribution logistics: Ensuring temperature-controlled supply chains, if necessary, and timely delivery to healthcare providers.

Because EYSUVIS is a niche ophthalmic drug, its volume of procurement is specialized, emphasizing the importance of close coordination between manufacturers and distributors. The recent surge in demand, driven by increased prevalence of dry eye disease and expanding indications, has spotlighted the need for diversified supply sources.

Emerging Suppliers and Potential Market Entrants

As the market for dry eye therapies grows, industry analysts predict potential entry points for new suppliers:

Generic manufacturers: Although EYSUVIS is proprietary to Kala Pharmaceuticals, variations in manufacturing or similar formulations could be produced by generic pharmaceutical companies once patent protections expire. Generic manufacturers typically obtain licensing or sublicense agreements with patent holders.
International manufacturers: Countries such as India and China have a burgeoning ophthalmic pharmaceutical industry. Companies like Sun Pharmaceutical, Dr. Reddy's Laboratories, and Zydus Cadila may seek to develop or supply similar corticosteroid formulations for export markets, contingent on regulatory approvals.
Contract manufacturing expansion: Existing CMOs may expand their capacity or develop proprietary formulations of loteprednol etabonate, offering alternative supply routes to Kala Pharmaceuticals or other licensees.

Strategic Note: The exclusivity of Kala Pharmaceuticals’s manufacturing rights limits supply alternatives in the short term. However, patent expiration, licensing agreements, or licensing of similar formulations can introduce new suppliers over time.

Supply Risks and Considerations

Supply dynamics for EYSUVIS are subject to:

Manufacturing capacity constraints due to complex formulation requirements.
Regulatory hurdles that may delay approval or manufacturing certification in new markets.
Global supply chain disruptions, exemplified during the COVID-19 pandemic, impacting raw material availability and shipping logistics.
Intellectual property rights: Patent protections reinforce exclusivity but also restrict the entry of generic competitors until expiration.

Proactive supply chain management entails establishing relationships with multiple CMOs and distributors, securing raw material sourcing agreements, and monitoring regulatory landscapes in key markets.

Regulatory and Market Outlook

The future landscape points toward:

Potential patent challenges or expirations that could permit generic manufacture.
Expansion into international markets, where local or regional suppliers may emerge.
Development of combination therapies that integrate EYSUVIS or similar corticosteroids, broadening supplier options.

Given the current proprietary status, Kala Pharmaceuticals remains the dominant supplier. Their ability to scale production, maintain quality standards, and navigate regulatory pathways will largely determine the stability of EYSUVIS’s supply.

Key Takeaways

Kala Pharmaceuticals is the primary manufacturer and supplier of EYSUVIS, leveraging its proprietary formulation and manufacturing capabilities.
The supply chain involves partnerships with CMOs, and logistics through major wholesalers and specialty pharmacies.
Market entrants are limited currently; however, generic manufacturers, international producers, and expanded contract manufacturing services pose potential future supply sources.
Supply stability hinges on manufacturing capacity, raw material availability, patent status, and regulatory frameworks.
Strategic diversification, including developing alternative supplier relationships and monitoring patent timelines, is essential for stakeholders seeking resilient procurement options.

FAQs

1. Who are the main suppliers of EYSUVIS?
Currently, Kala Pharmaceuticals is the exclusive manufacturer and primary supplier of EYSUVIS. The company leverages partnerships with contract manufacturing organizations to meet market demand.

2. Can other companies produce EYSUVIS besides Kala Pharmaceuticals?
In theory, yes, once patent protections expire or through licensing agreements. Currently, no other company has obtained rights to manufacture EYSUVIS, but international or generic manufacturers may enter the market in the future.

3. How is EYSUVIS dispatched to healthcare providers?
It is distributed via wholesale distributors such as McKesson, AmerisourceBergen, and Cardinal Health, which supply hospitals, clinics, and specialty pharmacies.

4. Are there potential risks to the supply of EYSUVIS?
Yes. Risks include manufacturing capacity limitations, raw material shortages, regulatory delays, and global supply chain disruptions, especially given its complex formulation.

5. What should stakeholders do to ensure reliable supply?
Stakeholders should diversify supplier relationships, establish agreements with multiple CMOs, stay informed about patent statuses, and develop contingency plans to mitigate supply disruptions.

References

[1] U.S. Food and Drug Administration. (2020). EYSUVIS (loteprednol etabonate ophthalmic suspension) approval notice.
[2] Kala Pharmaceuticals. (2020). Product pipeline and manufacturing overview.
[3] Industry reports on ophthalmic manufacturing and supply chain management.
[4] Patent and licensing case studies relevant to ophthalmic corticosteroids.

Suppliers and packagers for EYSUVIS

EYSUVIS

Suppliers for the Pharmaceutical Drug: EYSUVIS