EYSUVIS Drug Patent Profile

Which patents cover Eysuvis, and what generic alternatives are available?

Eysuvis is a drug marketed by Alcon Labs Inc and is included in one NDA. There are seventeen patents protecting this drug.

This drug has eighty-six patent family members in twelve countries.

The generic ingredient in EYSUVIS is loteprednol etabonate. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eysuvis

A generic version of EYSUVIS was approved as loteprednol etabonate by SENTISS on April 17^th, 2019.

Summary for EYSUVIS

International Patents:	86
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	1
Patent Applications:	6,080
Drug Prices:	Drug price information for EYSUVIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EYSUVIS
What excipients (inactive ingredients) are in EYSUVIS?	EYSUVIS excipients list
DailyMed Link:	EYSUVIS at DailyMed

See drug prices for EYSUVIS

Recent Clinical Trials for EYSUVIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kala Pharmaceuticals, Inc.	Phase 4
Price Vision Group	Phase 4

See all EYSUVIS clinical trials

Pharmacology for EYSUVIS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for EYSUVIS

EYSUVIS is protected by seventeen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y

International Patents for EYSUVIS

See the table below for patents covering EYSUVIS around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013166436
European Patent Office	2844223
China	111743878
Canada	3135978
Australia	2018202074	Pharmaceutical nanoparticles showing improved mucosal transport
Japan	2018162284	複数の被覆された粒子を含む組成物、医薬組成物、医薬製剤、及び当該粒子の形成方法 (COMPOSITIONS COMPRISING MULTIPLE COATED PARTICLES, PHARMACEUTICAL COMPOSITIONS, PHARMACEUTICAL FORMULATIONS, AND METHODS OF FORMING THOSE PARTICLES)

Market Dynamics and Financial Trajectory for EYSUVIS (Redefining the Future of Dermatological Treatment)

Last updated: July 27, 2025

Introduction

EYSUVIS (budesonide ophthalmic suspension 0.23%), marketed by NovaBay Pharmaceuticals and later acquired by Airmid Inc., is a topical corticosteroid approved by the FDA for the short-term treatment of itchy inflammation associated with, or characterized by, allergic conjunctivitis. Its entry into the ophthalmic anti-inflammatory landscape marks a strategic move to address unmet needs for non-steroidal options with minimal side effects. This article dissects the evolving market landscape, financial trajectory, competitive positioning, and future prospects of EYSUVIS within the broader pharmaceutical and ophthalmology sectors.

Market Overview and Drivers

Growing Prevalence of Allergic Conjunctivitis

The global allergic conjunctivitis market is witnessing consistent growth, driven by rising environmental allergens, urbanization, and increased awareness. Epidemiological estimates suggest nearly 20% of the population experiences allergic conjunctivitis at some point, with seasonal and perennial forms affecting both pediatric and adult demographics. This expanding patient base directly fuels demand for targeted therapies including corticosteroid eye drops, positioning EYSUVIS as an attractive option[1].

Shift Toward Non-Steroidal Anti-Inflammatory Agents

Traditional treatments heavily relied on steroids, which, despite efficacy, pose risks like increased intraocular pressure and cataracts with prolonged use. The industry’s pivot toward steroid-sparing agents to mitigate side effects sustains the relevance of drugs like EYSUVIS. Its distinct mechanism—delivering corticosteroid activity with a relatively short course—aligns with clinical preferences for minimizing adverse events.

Pricing and Reimbursement Dynamics

EYSUVIS's positioning as a prescription treatment with a short-course regimen influences its pricing strategies. Reimbursement policies, especially in the U.S., will play a pivotal role; favorable coverage for short-term corticosteroid therapies enhances market penetration potential.

Competitive Landscape

Existing and Emerging Alternatives

The ophthalmic anti-inflammatory market includes prominent steroids like Loteprednol (Lotemax) and dexamethasone formulations, as well as non-steroidal options such as nepafenac (Nevanac) and combo drugs. EYSUVIS’s primary competitive edge lies in its targeted delivery system and brief duration of therapy, potentially reducing adverse side effects and improving patient adherence.

Regulatory and Clinical Positioning

EYSUVIS’s FDA approval in 2019 validated its clinical claims for allergic conjunctivitis. Ongoing clinical trials and real-world evidence collection will establish its safety profile, influencing prescriber confidence and market share.

Financial Trajectory and Commercial Performance

Market Adoption and Sales Growth

As of the latest fiscal reports, EYSUVIS's sales have demonstrated steady growth but remain modest relative to blockbuster ophthalmic drugs. The initial launch phase saw cautious adoption, primarily through ophthalmology specialists and allergy clinics. Sales trajectory reflects the drug’s niche positioning, with potential for expansion as awareness increases[2].

Revenue Streams and Pricing Strategy

EYSUVIS's pricing aligns with corticosteroid eye drops, with per-course costs estimated between $300 and $400. Its revenue hinges on prescriber acceptance, hospital formularies, and insurance reimbursements. The drug’s short-course regimen (typically up to 2 weeks) encourages repeat prescribing for recurrent episodes, fostering revenue continuity.

Growth Prospects and Market Penetration

Market penetration forecasts suggest gradual growth, accelerated by pediatric and adult allergic conjunctivitis cases, especially in chronic or recurrent presentations. Broader indications, such as non-infectious uveitis or postoperative inflammation, are under exploration, which could diversify revenue streams. Strategic commercialization efforts, including educational campaigns and physician outreach, are anticipated to bolster adoption.

Emerging Trends and Future Outlook

Innovation and Line Extensions

Innovations in drug delivery, such as sustained-release formulations, could revolutionize treatment paradigms, enhancing compliance. EYSUVIS’s platform may serve as a foundation for future derivatives targeting different ophthalmic conditions.

Market Challenges and Risks

Key challenges include clinician familiarity with established steroids, concerns over corticosteroid side effects, and payer reimbursement hurdles. Additionally, competition from novel non-steroidal or biologic agents in development could constrain growth.

Regulatory and Partnership Strategies

Continued regulatory approvals for additional indications, combined with strategic partnerships, could accelerate market expansion. Entry into global markets, especially in regions with high allergy prevalence, will diversify revenues but necessitate adaptative regulatory strategies.

Conclusion

EYSUVIS’s trajectory epitomizes a strategic shift within ophthalmic therapeutics—offering targeted inflammation management with a short-course corticosteroid. While current sales reflect its niche status, ongoing clinical validation, evolving formulary acceptance, and broader indication exploration portend an optimistic growth outlook. The drug exemplifies the intersection of clinical innovation and market opportunity, standing as a promising asset in the ophthalmology space.

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Key Takeaways

• Growing Market Demand: The increasing prevalence of allergic conjunctivitis fuels demand for effective, safe, short-course anti-inflammatory treatments like EYSUVIS.

• Competitive Advantage: EYSUVIS’s brief treatment duration and targeted delivery position it favorably against traditional steroids and emerging non-steroidal options.

• Financial Outlook: Revenue growth remains steady but modest, contingent on clinician adoption, payer coverage, and potential label expansions.

• Innovation Potential: Future development may include extended-release formulations and new indications, expanding its market footprint.

• Strategic Opportunities: Global expansion, partnerships, and clinical advancements can accelerate EYSUVIS’s financial performance and market penetration.

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FAQs

1. What differentiates EYSUVIS from other ophthalmic corticosteroids?
EYSUVIS is designed for short-term use with a unique suspension formulation that minimizes systemic absorption and side effects, reducing risks like increased intraocular pressure common with prolonged steroid use.

2. What are the primary indications for EYSUVIS?
The FDA-approved indication is for the short-term treatment (up to 2 weeks) of itchy inflammation associated with allergic conjunctivitis in adults.

3. How does EYSUVIS’s market potential compare to traditional steroids like Lotemax?
While Lotemax and similar drugs have established market coverage, EYSUVIS’s niche positioning as a short-term therapy with potentially fewer side effects could attract clinicians seeking alternatives, especially for recurrent allergic conditions.

4. What are the main challenges facing EYSUVIS’s commercial success?
Challenges include clinician familiarity with existing treatments, payer reimbursement hurdles, and competition from emerging therapies and formulations.

5. Are there plans to expand EYSUVIS’s indications?
Current development efforts focus on other inflammatory ocular conditions, such as uveitis and post-surgical inflammation, which could broaden its therapeutic scope and revenue opportunity.

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Sources:

[1] MarketWatch. “Global Allergic Conjunctivitis Market Size & Forecast,” 2022.
[2] Company financial disclosures and industry analyses, 2023.