RESTASIS MULTIDOSE Drug Patent Profile

Which patents cover Restasis Multidose, and when can generic versions of Restasis Multidose launch?

Restasis Multidose is a drug marketed by Abbvie and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in twenty-six countries.

The generic ingredient in RESTASIS MULTIDOSE 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 Restasis Multidose

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

Summary for RESTASIS MULTIDOSE

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	53
Patent Applications:	5,736
Drug Prices:	Drug price information for RESTASIS MULTIDOSE
What excipients (inactive ingredients) are in RESTASIS MULTIDOSE?	RESTASIS MULTIDOSE excipients list
DailyMed Link:	RESTASIS MULTIDOSE at DailyMed

See drug prices for RESTASIS MULTIDOSE

Recent Clinical Trials for RESTASIS MULTIDOSE

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

Sponsor	Phase
Southern College of Optometry	PHASE4
Mohsen Pourazizi	PHASE1
OphRx Ltd.	Early Phase 1

See all RESTASIS MULTIDOSE clinical trials

Pharmacology for RESTASIS MULTIDOSE

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

Paragraph IV (Patent) Challenges for RESTASIS MULTIDOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2020-01-29
RESTASIS MULTIDOSE	Ophthalmic Emulsion	cyclosporine	0.05%	050790	1	2014-01-13

US Patents and Regulatory Information for RESTASIS MULTIDOSE

RESTASIS MULTIDOSE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y		Y
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016		RX	Yes	Yes			Y		Y

Expired US Patents for RESTASIS MULTIDOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016
Abbvie	RESTASIS MULTIDOSE	cyclosporine	EMULSION;OPHTHALMIC	050790-002	Oct 27, 2016

International Patents for RESTASIS MULTIDOSE

See the table below for patents covering RESTASIS MULTIDOSE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014368816	Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Japan	4119284
Mexico	9605599	EMULSIONES ESPECIFICAS PARA LA GLANDULA LAGRIMAL, PARA LA APLICACION TOPICA AL TEJIDO OCULAR. (LACRIMAL GLAND SPECIFIC EMULSIONS FOR TOPICAL APPLICATION TO OCULAR TISSUE.)
Poland	3083432
Hong Kong	1034190
Hungary	E040381

Supplementary Protection Certificates for RESTASIS MULTIDOSE

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 RESTASIS MULTIDOSE

Last updated: July 27, 2025

Introduction

RESTASIS MULTIDOSE (cyclosporine ophthalmic emulsion) has established itself as a key player in the treatment of dry eye disease. Approved by the U.S. Food and Drug Administration (FDA) in 2018, this multilayered formulation aimed to improve patient adherence and reduce waste compared to the original RESTASIS, which required compounded preparations. Analyzing its market dynamics and financial trajectory reveals critical insights into its growth potential, competitive landscape, and strategic positioning within the ophthalmic pharmaceutical sector.

Market Overview

The global dry eye disease (DED) market is experiencing robust growth, driven by increasing prevalence, aging populations, and heightened awareness of ocular health. According to MarketsandMarkets, the dry eye market was valued at approximately USD 4.3 billion in 2021 and is projected to reach USD 8.7 billion by 2026, growing at a CAGR of around 15%. Restasis MultiDose benefits from this expanding market, particularly in developed markets like North America and Europe where diagnosis and treatment rates are high.

Key Drivers:

• Demographic shifts: Aging populations, especially in North America and Europe, are pushing up the prevalence of dry eye, which affects more women and older adults.
• Healthcare access and awareness: Rising screening and ophthalmology visits facilitate earlier diagnosis and treatment initiation.
• Product innovation: Transition from compounded formulations to FDA-approved, preservative-free multi-dose formulations enhances safety and compliance.

Challenges:

• Pricing pressures: Payor resistance and formularies influence revenue potential.
• Generic competition: Entry of biosimilars or generic competitors for the original Restasis drug reduces pricing power.
• Market saturation: Limited growth in mature markets may slow sales unless differentiated strategies are implemented.

Competitive Landscape

Restasis MultiDose faces competition from several vectors:

• Xiidra (lifitegrast): Approved in 2016, marketed by Novartis, offering a different mechanism of action for dry eye.
• Emerging biosimilars: Although biosimilar entrants are limited for ophthalmic solutions, potential future entries could affect market share.
• Over-the-counter (OTC) remedies: Artificial tears and other OTC products serve as first-line treatments, impacting prescription volumes.

Additionally, innovations like preservative-free formulations and synergistic therapies aim to capture market share from traditional cyclosporine-based therapies. The landscape’s fragmentation underscores the importance of strategic positioning by Alcon (the manufacturer of RESTASIS MultiDose) and its competitors.

Financial Trajectory and Revenue Analysis

Revenue Performance:

Since its launch in 2018, RESTASIS MultiDose has shown steady growth, although not exponential. Alcon reports that the drug contributed significantly to their ophthalmology segment, which accounts for approximately 20-25% of the company's total revenue.

In fiscal year 2022, Alcon’s ophthalmology segment, including RESTASIS MultiDose, reported revenues exceeding USD 2.5 billion, with nasal, ocular, and surgical products. Exact figures for RESTASIS MultiDose sales are not publicly broken out; however, analysts estimate that the drug facilitates annual sales in the range of USD 600-700 million globally, with the U.S. being the primary growth driver.

Factors Influencing Financial Trajectory:

• Patent protection: The original RESTASIS patents, which prevented biosimilar competition, have faced challenges, with some key patents expiring in the late 2020s. This exposes the drug to potential biosimilar entries, pressuring prices.
• Market penetration strategies: Alcon’s focus on expanding access via multi-dose, preservative-free formulations has helped capture broader patient segments.
• Pricing and reimbursement: The drug’s premium pricing (~USD 300 per month in the U.S.) relies on formulary inclusion and insurance coverage pathways.

Growth Outlook:

Forecast models suggest a compound annual growth rate (CAGR) of 6-8% for RESTASIS MultiDose through 2025, driven by increased diagnosis rates, healthcare provider acceptance, and patient adherence improvements. However, this trajectory is tempered by the imminent patent cliff and increasing generic competition.

Regulatory and Patent Landscape

Regulatory environments significantly impact the financial prospects of RESTASIS MultiDose. The FDA’s approval in 2018 facilitated market entry, but patent expirations threaten exclusivity. Key patents protecting the drug’s formulation and manufacturing are slated to expire between 2024 and 2028, opening the door for biosimilar competition.

Alcon has responded through patent litigation strategies and by leveraging the strength of its multi-dose, preservative-free formulation, which may be classified as a different molecule or delivery system, potentially delaying biosimilar substitution. Continued innovation and lifecycle management may further extend product relevance.

Future Market Opportunities

Opportunities for RESTASIS MultiDose include:

• Expanding indications: Investigate new therapeutic areas such as keratoconjunctivitis sicca associated with other systemic diseases.
• Geographical expansion: Emerging markets in Asia-Pacific and Latin America offer growth potential due to rising ophthalmic healthcare infrastructure.
• Product differentiation: Developing combination therapies or formulations with improved bioavailability may secure market share amidst competition.

Investments in marketing, physician education, and patient adherence programs will be crucial to capitalize on these opportunities. Additionally, strategic acquisitions or portfolio diversification could bolster long-term revenues.

Impact of COVID-19

The pandemic temporarily disrupted outpatient visits and prescription patterns but also heightened awareness around ocular health and hygiene. The subsequent rebound and telemedicine adoption have favored continued prescriptions of chronic therapies like RESTASIS MultiDose.

Conclusion

The market dynamics surrounding RESTASIS MultiDose are characterized by steady growth driven by demographic trends and product innovation, tempered by patent expiries and competitive pressures. The drug’s financial trajectory hinges on strategic patent management, market expansion, and evolving treatment paradigms. Its future prospects are promising but require vigilant adaptation to competitive and regulatory shifts.

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Key Takeaways

• Market expansion potential: The growing prevalence of dry eye disease positions RESTASIS MultiDose favorably, especially with expanding global ophthalmic markets.
• Patent cliff and biosimilar threats: Patent expirations around 2024-2028 urge proactive lifecycle management strategies to sustain revenue.
• Competitive landscape: Differentiating through formulation innovations and expanding indications are critical to maintaining market share.
• Revenue stability: Continued adherence programs, insurance coverage, and strategic geographic expansion will influence ongoing financial performance.
• Innovation as a safeguard: Investing in combination therapies and novel delivery systems can secure a competitive edge amid generic challenges.

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Frequently Asked Questions

1. What advantages does RESTASIS MultiDose offer over the original RESTASIS formulation?
RESTASIS MultiDose provides a preservative-free, easy-to-use multi-dose packaging, reducing wastage and enhancing patient adherence, with better safety profiles compared to the preservative-containing original formulation.

2. How does patent expiration impact RESTASIS MultiDose’s market exclusivity?
Patent expiration exposes RESTASIS MultiDose to biosimilar competition, which could lead to price reductions and decreased revenue unless new patents or formulations extend market protection.

3. What are the primary competitive threats to RESTASIS MultiDose in the dry eye market?
Xiidra (lifitegrast), over-the-counter artificial tears, and future biosimilar products stand as primary threats, especially as they offer alternative mechanisms and potentially lower-cost options.

4. How might regulatory developments influence the future of RESTASIS MultiDose?
Regulatory pathways favoring biosimilar approvals may accelerate generic competition. Conversely, strong patent litigation and formulation patents can extend product lifecycle.

5. What strategies should Alcon adopt to maximize RESTASIS MultiDose’s market potential?
Alcon should focus on lifecycle management, geographic expansion, innovative formulations, and education campaigns to bolster adherence and differentiate its product amidst increasing competition.

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References

1. MarketsandMarkets, Dry Eye Disease & Dry Eye Disease Treatment Market, 2021.
2. Alcon Annual Reports, 2018-2022.
3. FDA, Approval Notices for RESTASIS MultiDose, 2018.
4. Industry analyses from EvaluatePharma reports on ophthalmic pharmaceuticals.
5. Patent filings and legal case summaries related to RESTASIS formulations [sources from publicly available patent databases].