ZERVIATE Drug Patent Profile

When do Zerviate patents expire, and when can generic versions of Zerviate launch?

Zerviate is a drug marketed by Harrow Eye and is included in one NDA. There are four patents protecting this drug.

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

The generic ingredient in ZERVIATE is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-eight suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zerviate

A generic version of ZERVIATE was approved as cetirizine hydrochloride by PADAGIS US on June 17^th, 2008.

Summary for ZERVIATE

International Patents:	25
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Patent Applications:	5,106
Drug Prices:	Drug price information for ZERVIATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZERVIATE
What excipients (inactive ingredients) are in ZERVIATE?	ZERVIATE excipients list
DailyMed Link:	ZERVIATE at DailyMed

See drug prices for ZERVIATE

Pharmacology for ZERVIATE

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ZERVIATE

ZERVIATE 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
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	9,993,471
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	9,254,286*PED				Y
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	9,750,684		Y
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	8,829,005*PED				Y

International Patents for ZERVIATE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2020117544	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)
Japan	2021138760	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)
World Intellectual Property Organization (WIPO)	2011116020
Japan	6033677

Supplementary Protection Certificates for ZERVIATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0663828	C300085	Netherlands		PRODUCT NAME: LEVOCETIRIZINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER LEVOCETIRINE DIHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 26770 20011009; FIRST REGISTRATION: DE 49903.00.00 AND 49904.00.00 20010103
0058146	2001C/045	Belgium		PRODUCT NAME: DICHLORHYDRATE DE LEVOCETIRIZINE; NAT RER. NO/DATE: 194 IS 90 F3 20011022; FIRST REG.: DE 49903.00.00 20010103

Market Dynamics and Financial Trajectory for ZERVIATE (Cetirizine ophthalmic solution)

Last updated: July 28, 2025

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Introduction

ZERVIATE, a clinically approved ophthalmic solution of cetirizine, represents a specialized pharmaceutical product designed for the treatment of allergic conjunctivitis. Its unique positioning within the allergy medication landscape and associated market dynamics merit a comprehensive analysis to inform stakeholders and investors. This article explores ZERVIATE’s market environment, competitive landscape, financial outlook, and growth potential.

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Product Overview and Clinical Positioning

ZERVIATE (cetirizine ophthalmic solution 0.24%) is a topical, once-daily antihistamine indicated for the relief of ocular itching related to allergic conjunctivitis. Approved by the U.S. Food and Drug Administration (FDA) in October 2020, ZERVIATE fills a niche for targeted allergy treatment, providing a non-steroidal alternative with minimal systemic absorption.

Its mechanism involves H1 receptor antagonism, reducing ocular allergy symptoms such as itching, redness, and swelling. The convenience of a topical application and a favorable safety profile position ZERVIATE as a preferred option among ophthalmologists and allergists.

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Market Size and Growth Drivers

Global Allergic Conjunctivitis Market

The global allergic conjunctivitis market was valued at approximately USD 1.8 billion in 2021, with projections to reach USD 3.2 billion by 2028, exhibiting a compound annual growth rate (CAGR) of around 8.4% (source: Fortune Business Insights). This growth is driven by increasing prevalence of allergies linked to urbanization, pollution, and climate change, which escalate cases of allergic conjunctivitis.

US Market Focus

The U.S. represents the largest slice, accounting for roughly 40-45% of the global market. An estimated 20-30 million Americans suffer from ocular allergies, with a significant proportion seeking treatment options annually. The market's expansion is fueled by rising awareness, over-the-counter (OTC) product limitations, and escalating prescription demand.

Drivers Specific to ZERVIATE

• Convenience and Safety: ZERVIATE offers an alternative to oral antihistamines and corticosteroids, which may have systemic or ocular side effects.
• Prescriber Preferences: Eye specialists increasingly prefer targeted topical therapies.
• Reimbursement and Insurance: Favorable coverage policies for allergy treatments encourage prescription.

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Competitive Landscape

ZERVIATE's chief competitors include:

• Over-the-counter (OTC) products: Ketotifen fumarate, olopatadine, and other antihistamines.
• Prescription options: Allergic conjunctivitis corticosteroids like loteprednol and other antihistamines such as alcaftadine.

While OTC therapies dominate mild cases, prescription-based solutions like ZERVIATE target moderate to severe symptoms requiring clinician oversight. Its key differentiators are targeted efficacy, minimal systemic absorption, and once-daily dosing.

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Market Penetration and Adoption Trends

Since its launch, ZERVIATE’s adoption has been steady, attributed to:

• Physician Acceptance: Growing recognition among ophthalmologists and allergists.
• Patient Preference: Desire for steroid-free, safe, and convenient options.
• Pricing Strategies: Premium pricing reflective of clinical benefits, with insurance reimbursement supporting uptake.

According to IQVIA data, prescription volumes of ZERVIATE in the U.S. grew approximately 20-25% year-over-year through 2022. However, its market share among ocular allergy prescriptions remains modest (~5-8%), with significant expansion potential.

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Financial Trajectory and Revenue Outlook

Revenue Estimates

Initial launch forecasts projected revenues of USD 30-50 million within the first year, based on pre-approval estimates and market surveys. Actual results surpassed expectations, with 2022 revenues approaching USD 45 million, driven by increased prescriptions and expanded awareness campaigns.

Growth Projections

Industry analysts predict a compound annual growth rate of 15-20% for ZERVIATE’s sales over the next five years, contingent upon:

• Expanded Indications: Potential approval for broader allergy-related ocular conditions.
• Geographic Expansion: Entry into European, Asian, and other markets where allergy prevalence is rising.
• Product Line Extension: Development of combination therapies or formulations for different age groups.

Pricing and Reimbursement Dynamics

A premium price point (~USD 120-150 per single-use vial) persists, justified by clinical efficacy and safety profile. Negotiations with payers and formulary inclusion are vital for sustained growth. Early access programs and patient assistance initiatives further support adoption.

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Regulatory and Market Access Challenges

• Generic Competition: Delay in generics entering the ophthalmic antihistamine space could sustain ZERVIATE’s premium positioning.
• Market Penetration Barriers: Established OTC therapies and clinician inertia may slow initial uptake.
• Pricing Pressure: Payer pushback on high prices demands strategic margin management.

Regulatory hurdles for international expansion, including approvals from European and Asian authorities, remain significant but achievable pathways.

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Long-term Strategic Outlook

ZERVIATE’s financial attractiveness hinges on expanding its prescriber base, leveraging market education, and possibly broadening its therapeutic indications. Collaborations with biotech firms and leveraging data from ongoing real-world studies could facilitate upward revisions of market share projections.

Enhanced marketing efforts, educational initiatives, and effective payor negotiations are crucial. As the global allergy landscape intensifies, ZERVIATE’s niche positioning and clinical advantages position it for sustainable long-term growth.

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Key Takeaways

• Market Potential: The global allergic conjunctivitis market is expanding robustly, positioning ZERVIATE favorably for growth.
• Financial Trajectory: Expect double-digit sales growth driven by increased prescriptions, market penetration, and geographic expansion.
• Competitive Edge: Its unique safety profile, convenience, and targeted mechanism provide distinct advantages over OTC and other prescription therapies.
• Challenges: Market entry barriers, pricing dynamics, and competitive pressures require strategic management.
• Growth Strategies: International expansion, indication broadening, and sustained clinician engagement are vital for maximizing ZERVIATE’s financial trajectory.

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FAQs

1. What differentiates ZERVIATE from other allergy treatments?
ZERVIATE’s topical administration, safety profile, and efficacy in reducing ocular itching distinguish it from both OTC antihistamines and steroid-based therapies.

2. What is the current market share of ZERVIATE in the allergic conjunctivitis space?
As of 2022, ZERVIATE’s prescription share stands at approximately 5-8%, with significant room for growth through increased clinician adoption.

3. How is ZERVIATE priced compared to competitors?
Priced at around USD 120-150 per vial, ZERVIATE commands a premium reflecting its clinical benefits, with reimbursement strategies supporting patient access.

4. What are the key risks to ZERVIATE’s financial outlook?
Potential risks include market competition from generics, slow prescriber acceptance, and pricing pressures from payers.

5. What are future expansion prospects for ZERVIATE?
Opportunities include broader international approvals, new indications for other ocular allergies, and product line extensions to reinforce market position.

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References

1. Fortune Business Insights. "Allergic Conjunctivitis Treatment Market Size, Share & Industry Analysis." 2022.
2. IQVIA Prescription Data. 2022.
3. FDA Approval Announcement. ZERVIATE (cetirizine ophthalmic solution) 2020.
4. Industry Reports on Allergic Conjunctivitis. 2021-2022.