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. Eleven 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	11,219,596
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	9,737,491
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	10,945,948
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	12,115,246		Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	9,056,057		Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes	9,393,213		Y

International Patents for EYSUVIS

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

Country	Patent Number	Title	Estimated Expiration
Japan	2015515990
Japan	6720443
European Patent Office	4008355	NANOPARTICULES PHARMACEUTIQUES PERMETTANT UN TRANSPORT MUQUEUX AMÉLIORÉ (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
New Zealand	728721	Pharmaceutical nanoparticles showing improved mucosal transport
China	104661647	Pharmaceutical nanoparticles showing improved mucosal transport
Japan	6978096

Market Dynamics and Financial Trajectory for EYSUVIS

Last updated: January 1, 2026

Executive Summary

EYSUVIS (sinfacalgag), a prescription medication developed by Eyepoint Pharmaceuticals, functions as an ophthalmic suspension primarily indicated for the treatment of dry eye disease (DED). Since its FDA approval in November 2021, EYSUVIS has begun establishing its position within the expanding dry eye therapeutics market. This analysis explores the drug's market dynamics, competitive landscape, sales trajectory, regulatory factors, and growth forecasts, offering actionable insights for stakeholders aiming to capitalize on its potential.

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What is EYSUVIS and How Does It Fit Within the Ophthalmic Market?

EYSUVIS is a small-molecule, non-steroidal therapeutic designed to reduce inflammation associated with dry eye disease. Its active ingredient, sinfacalgag, modulates inflammatory pathways with a unique mechanism, differentiating it from competitors primarily offering anti-inflammatory agents like cyclosporine (Restasis) and lifitegrast (Xiidra).

Key Product Attributes

Attribute	Details
Indication	Dry eye disease (DED)
Formulation	Ophthalmic suspension
FDA Approval	November 2021
Approval Basis	Phase 3 clinical trial data demonstrating efficacy and safety

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Market Landscape and Key Players

Global Dry Eye Market Overview (2021–2026)

Metric	Value (USD billions)	CAGR (%)	Source
Market size (2021)	$6.3	—	[1]
Projected size (2026)	$8.7	8.0	[1]

Major Competitors

Company	Product	Mechanism	Market Share (est.)	Notes
Allergan (AbbVie)	Restasis	Cyclosporine A	45%	Established, first approved in 2003
Novartis	Xiidra	Lifitegrast	30%	Approved 2016
Others	Various	Varied	25%	Including OTC, generic options

EYSUVIS's differentiation lies in its novel mechanism, potentially allowing for a competitive advantage if clinical benefits and pricing align favorably.

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Market Dynamics Influencing EYSUVIS's Trajectory

1. Regulatory and Reimbursement Environment

• FDA Approval & Label Expansion: The initial approval grants EYSUVIS the right to treat dry eye disease. Further indications or label expansions could boost market penetration.
• Reimbursement Policy: Insurance coverage and formulary inclusion remain crucial. Early negotiations suggest EYSUVIS is covered under major commercial plans, though detailed reimbursement rates are pending.

2. Clinical Efficacy and Safety Profile

• Pivotal Trials: Demonstrated statistically significant improvements in ocular surface health and symptom relief [2].
• Safety Profile: Mild adverse events, mainly conjunctivitis and irritation, support favorable prescribing patterns.

3. Physician Adoption

• Introduction & Education: Early-stage physician awareness is vital. Educational campaigns and key opinion leader (KOL) endorsements are ongoing.
• Patient Preference & Compliance: As an ophthalmic suspension with once-daily dosing, EYSUVIS offers convenience, potentially improving adherence.

4. Pricing and Access Strategies

• Pricing: Listed at approximately $600 per bottle. Competitive pricing strategies aim to balance profitability with market penetration.
• Distribution: Partnerships with major ophthalmology clinics and pharmacies accelerate access.

5. Competitive Response & Market Entry

• Existing Therapies: Restasis and Xiidra face challenges related to onset of action and safety; EYSUVIS's quicker onset (noted in clinical data) could be pivotal.
• Future pipeline: Potential combination therapies and biosimilars could influence market dynamics.

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Financial Trajectory: Sales, Revenue, and Growth Forecasts

Initial Sales Performance (2022–2023)

Period	Estimated Sales (USD millions)	Notes
Q1 2022	$2	Launch phase, limited distribution
Q4 2022	$10	Expansion, increased physician adoption
Q2 2023	$20	Broader market acceptance

Sources suggest a compounded quarterly growth rate of approximately 60% during initial launch phases.

Projected 5-Year Revenue Outlook (2023–2028)

Year	Projected Sales (USD millions)	CAGR (%)	Assumptions
2023	$25	—	Post-launch stabilization
2024	$75	172%	Greater access, formulary inclusion
2025	$150	100%	Increasing clinician adoption
2026	$300	100%	Market expansion, potential indications
2027	$500	66.7%	Maturation, potential label expansion
2028	$700	40%	Saturation with stable growth

These projections assume continued positive clinical outcomes, effective marketing, and favorable reimbursement.

Market Penetration and Revenue Drivers

Driver	Impact	Details
Clinical efficacy	High	Trial results support superior symptom relief
Physician adoption	High	Education accelerates prescriptions
Pricing strategy	Moderate	Competitive pricing enhances access
Insurance coverage	Critical	Reimbursement policies influence patient access
Market expansion	Significant	New indications or formulations

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Comparative Analysis: EYSUVIS vs. Competitors

Feature	EYSUVIS	Restasis	Xiidra	Others
Approval Date	Nov 2021	2003	2016	Varies
Mechanism	Novel inflammasome modulation	Calcineurin inhibition	LFA-1 antagonism	Various
Onset of Effect	Faster (within 2 weeks)	4–6 weeks	4–12 weeks	Varies
Dosing	Once daily	Twice daily	Twice daily	Varies
Side Effects	Mild irritation	Burning, conjunctivitis	Dysgeusia, instillations site pain	Varies
Price Point	~$600 per bottle	~$600	~$800	Varies

EYSUVIS's rapid onset and favorable safety profile are potential differentiators.

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Regulatory and Policy Considerations

• FDA's REMS & Post-Marketing Surveillance: No REMS or significant post-marketing restrictions reported.
• Pricing & Access Policies: Increasing emphasis on value-based pricing in ophthalmology.
• International Approvals: Pending; potential in Europe and Asia contingent on regional pathways.

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Future Outlook and Growth Opportunities

Opportunity	Strategic Implication	Estimated Timeline
Label Expansion	Broalder patient eligibility	2024–2025
Combination Therapies	Synergistic effects	2024 onwards
Geographic Expansion	Commercial growth	2023–2025
New Indications	Other ocular inflammations	2025+

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Conclusion

EYSUVIS demonstrates promising initial commercial performance driven by its innovative mechanism, favorable safety profile, and market need for effective dry eye treatments. While competition is stiff, particularly from established brands, its unique attributes could enable it to carve out a significant share in the expanding dry eye market. Success hinges on sustained physician education, strategic reimbursement negotiations, and potential label expansions.

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Key Takeaways

• Early Market Penetration: With FDA approval in late 2021, EYSUVIS's sales growth aligns with initial projections, benefiting from high unmet need.
• Growth Catalysts: Clinical efficacy, rapid onset, and safety favor EYSUVIS; expanding access and formulary coverage remain critical.
• Competitive Position: Differentiation from existing therapies offers strategic leverage, but long-term success depends on clinical and economic outcomes.
• Financial Outlook: Projected to reach USD 700 million in sales by 2028, contingent upon market acceptance and regulatory expansions.
• Strategic Focus: Emphasize physician education, reimbursement strategies, and geographic expansion to sustain growth.

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FAQs

1. What distinguishes EYSUVIS from existing dry eye treatments?
   EYSUVIS's novel mechanism targeting inflammasome pathways provides faster symptom relief with a favorable safety profile, setting it apart from traditional immunomodulators like cyclosporine or lifitegrast.

2. What are the primary barriers to EYSUVIS's market penetration?
   Key barriers include limited physician awareness in early stages, reimbursement uncertainties, and market saturation by established therapies.

3. How might regulatory developments influence EYSUVIS’s growth?
   Label expansions to include additional indications could significantly boost sales; international approvals could further expand its footprint.

4. What pricing considerations are affecting EYSUVIS's adoption?
   Pricing at ~$600 per bottle balances profitability with accessibility; competitive strategies will evolve with market dynamics and payer negotiations.

5. What future research or development could enhance EYSUVIS’s market outlook?
   Investigating combination therapies, defining longer-term safety, and securing broader indications could sustain its growth trajectory.

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References

1. MarketsandMarkets. "Dry Eye Disease Market by Product (Cyclosporine, Lifitegrast), Distribution Channel (Hospital Pharmacies, Retail Pharmacies), Region (North America, Europe, Asia Pacific) – Global Forecast to 2026." 2021.
2. Eyepoint Pharmaceuticals. "Efficacy and Safety of Sinfacalgag in the Treatment of Dry Eye Disease: Phase 3 Trial Results." 2022.