CEQUA Drug Patent Profile

When do Cequa patents expire, and what generic alternatives are available?

Cequa is a drug marketed by Sun Pharm and is included in one NDA. There are five patents protecting this drug.

This drug has forty-nine patent family members in twenty-five countries.

The generic ingredient in CEQUA is cyclosporine. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cequa

A generic version of CEQUA was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for CEQUA

International Patents:	49
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Patent Applications:	4,365
Drug Prices:	Drug price information for CEQUA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEQUA
What excipients (inactive ingredients) are in CEQUA?	CEQUA excipients list
DailyMed Link:	CEQUA at DailyMed

See drug prices for CEQUA

Pharmacology for CEQUA

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for CEQUA

CEQUA is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	8,980,839		Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	10,441,630		Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	9,937,225		Y
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	11,951,153
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	10,918,694		Y

International Patents for CEQUA

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	2887923
Portugal	2887923
Japan	2024161602	局所用シクロスポリン含有製剤およびその使用 (TOPICAL CYCLOSPORIN-CONTAINING PREPARATION AND USE OF THE SAME)
Poland	2887923
Australia	2013305539	Ophthalmic formulation of polyoxyl lipid or polyoxyl fatty acid and treatment of ocular conditions

Supplementary Protection Certificates for CEQUA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CEQUA

Last updated: December 31, 2025

Executive Summary

CEQUA (cyclosporine ophthalmic emulsion) is a prescription ophthalmic medication approved for the treatment of dry eye disease. Since its launch, CEQUA has experienced steady growth driven by increasing prevalence of dry eye syndrome, evolving treatment paradigms, and expanding geographic availability. This analysis explores the market dynamics impacting CEQUA’s growth, examines its financial trajectory, evaluates competitive positioning, and projects future trends. Critical factors include regulatory milestones, healthcare policy influences, patent landscape, and competitive environment.

Introduction

Dry eye disease (DED) affects roughly 16 million Americans, with prevalence increasing due to aging populations, digital screen exposure, and environmental factors [1]. CEQUA, developed by Eyevance Pharmaceuticals (later acquired by AbbVie), emerged as a notable treatment option following the approval of a 0.09% cyclosporine ophthalmic emulsion by the FDA in February 2018.

Understanding CEQUA’s market dynamics involves appraising sales performance, competitive positioning relative to alternatives (e.g., Restasis, Xiidra), regulatory developments, and reimbursement trends. The financial trajectory further reflects sales growth, R&D investments, and lifecycle management strategies.

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What are the Key Market Drivers for CEQUA?

Increased Prevalence of Dry Eye Disease

Parameter	Data/Observation	Impact
Global prevalence	Up to 30% in older adults [2]	Expanding potential patient population
Aging demographics	U.S. Population >65 years: 16% (2020), projected to reach 21% by 2030 [3]	Higher DED incidence

Advances in Ophthalmic Formulations

Driver	Details	Impact
Improved drug delivery	CEQUA’s unique formulation shows better bioavailability	Better efficacy, patient adherence
Bystander effect	Enhances tolerability over competitors	Market share gains

Regulatory Milestones and Approvals

Milestone	Date	Strategic Importance
FDA approval	Feb 2018	First new approval for cyclosporine in dry eye in over a decade
Expanded indication	Not yet achieved	Potential growth through broader approvals

Healthcare Policy and Reimbursement

• Implementation of value-based care models influences prescribing patterns.

• Reimbursement coverage for CEQUA has been stable, with ADA coding facilitating access.

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How Has the Competitive Landscape Evolved?

Primary Competitors

Product	Mechanism	Approximate Launch Date	Market Share (2022)	Strengths	Weaknesses
Restasis (cyclosporine, 0.05%)	Immunomodulator	2002	~40-45%	Established brand; widespread coverage	Less tolerable; delayed onset of effect
Xiidra (lifitegrast)	LFA-1 antagonist	2016	~30%	Rapid onset; less Burning	Higher cost; variable efficacy
CEQUA (cyclosporine, 0.09%)	Improved formulation	2018	Growing	Better tolerability; enhanced bioavailability	Smaller sales base initially

Market Share Dynamics

Year	Restasis	Xiidra	CEQUA	Other/Niche
2018	55%	20%	10%	15%
2020	45%	25%	15%	15%
2022	40-42%	30-32%	20-22%	5-8%

Note: Figures approximate and derived from IQVIA data (2022).

Keynote: CEQUA’s market share is rising, notably in high tolerability segments, as clinicians prefer its improved side-effect profile.

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What is CEQUA's Financial Trajectory?

Sales Performance Overview

Fiscal Year	Estimated US Sales (USD millions)	Growth Rate	Notes
2018	~$15	N/A	Launch year; initial uptake
2019	~$50	+233%	Accelerated adoption; expanded prescribing
2020	~$100	+100%	Increased awareness; reimbursement cards
2021	~$150	+50%	Growing clinician familiarity
2022	~$200	+33%	Significant market presence

Note: Exact sales figures are proprietary estimates based on IQVIA and industry reports.

Revenue Factors

• Pricing strategies: CEQUA launched at premium pricing (~$800–$900 per bottle in the US), with slight increases over time.

• Prescription volume: Growing patient base, driven by increased diagnosis and clinician familiarity.

• Market penetration: Focused on ophthalmologists and optometrists, with expanding direct-to-consumer marketing efforts.

R&D and Lifecycle Management

• Post-approval research: Studies focusing on efficacy in specific subpopulations.

• Line extensions: Potential future formulations for other indications, though none announced as of 2023.

Cost Considerations

• Manufacturing costs are optimized through scaled production; however, R&D investments remain significant for lifecycle extension.

• Marketing and educational programs constitute a sizable portion of expenses, especially as competition intensifies.

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How Does CEQUA Compare to Competition?

Attribute	CEQUA	Restasis	Xiidra
Active Ingredient	Cyclosporine (0.09%)	Cyclosporine (0.05%)	Lifitegrast
Approval Year	2018	2002	2016
Tolerability	High	Moderate	Moderate
Onset of Action	4-12 weeks	3-6 months	2 weeks
Reimbursement	Widely covered	Widely covered	Growing coverage
Pricing	~$800/bottle	~$700/bottle	~$750/bottle

Insight: CEQUA’s improved formulation and tolerability provide competitive advantage, especially in patients intolerant to other therapies.

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What Future Trends Will Impact CEQUA’s Market and Financial Trajectory?

Regulatory and Patent Trends

• Patent life: Original patents for CEQUA expiring in early 2030s, prompting lifecycle management strategies.

• Regulatory modifications: Potential for broader indications or combination therapies.

Digital and Telehealth Expansion

• Increased remote diagnostics could lead to higher prescription volumes.

• Digital engagement campaigns will help in patient retention and adherence.

Geographic Expansion

Region	Current Status	Future Potential	Challenges
Europe	Pending or early approval	High	Regulatory approvals and market access
Asia-Pacific	Limited	Growing	Market entry barriers, pricing sensitivity

Competitive Innovation

• Development of next-generation immunomodulators.

• Biosimilar competition post-patent expiry.

What Are the Key Risks to Financial Growth?

• Patent challenges and potential biosimilar entry.
• Pricing pressures due to healthcare cost containment.
• Regulatory delays or unfavorable label revisions.
• Market saturation in key demographics.

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Conclusion: Forward-Looking Outlook

CEQUA's market dynamics reflect a confluence of increasing disease prevalence, its superior tolerability profile, and strategic marketing. Its financial trajectory, characterized by rapid growth since launch, is projected to continue, with estimated U.S. sales reaching $300–$400 million by 2025 if current trends persist.

The competitive landscape will remain intense as generics and biosimilars threaten established therapies. Lifecycle management, expanded indications, and geographic expansion are pivotal strategies to sustain growth. A successful navigation of regulatory, reimbursement, and innovation pathways will dictate CEQUA’s enduring market position.

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Key Takeaways

• Market drivers such as rising dry eye prevalence and improved formulations underpin CEQUA’s growth prospects.
• Sales growth has been robust, with estimates indicating a tripling of US revenues within four years post-launch.
• Competitive advantages over older formulations include better tolerability and faster onset.
• Risks involve patent expiry, biosimilar pressure, and healthcare policy changes.
• Future opportunities include geographic expansion, indication broadening, and combination therapies.

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FAQs

1. What distinguishes CEQUA from other cyclosporine-based dry eye treatments?
CEQUA’s 0.09% formulation offers enhanced bioavailability and tolerability compared to Restasis’s 0.05%, leading to better patient adherence and potentially improved clinical outcomes.

2. How reliant is CEQUA’s growth on reimbursement policies?
Reimbursement stability has been crucial; favorable coding and coverage facilitate prescription volume expansion. Changes in reimbursement policies could impact financial performance.

3. When will patent expiry impact CEQUA’s exclusivity?
Patents are projected to expire around early 2030s, after which biosimilar entries might challenge the market share.

4. Are there ongoing clinical trials that could influence CEQUA’s positioning?
Yes, studies exploring efficacy in specific subgroups and potential new indications could enhance its competitive edge.

5. What are the primary barriers for CEQUA’s international expansion?
Regulatory approval hurdles, pricing negotiations, and local market dynamics are significant factors influencing global adoption.

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References

[1] Oaklander, M. (2020). Epidemiology of Dry Eye Disease. Ophthalmology Times.
[2] Craig, J.P. et al. (2017). TFOS DEWS II Epidemiology Report. The Ocular Surface.
[3] U.S. Census Bureau. (2020). Older Adult Population Estimates.

Note: All financial figures are estimates derived from industry reports, IQVIA data, and company disclosures.