ZERVIATE Drug Patent Profile

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

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-three 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-six 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:	23
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Patent Applications:	2,727
Drug Prices:	Drug price information 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
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes					Y
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes			Y
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes					Y

International Patents for ZERVIATE

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

Country	Patent Number	Title	Estimated Expiration
Spain	2910374
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)
European Patent Office	2408453	FORMULATIONS OPHTALMIQUES DE CÉTIRIZINE ET PROCÉDÉS D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)
Japan	2015007136	セチリジンの眼科用製剤および使用方法 (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)
World Intellectual Property Organization (WIPO)	2011116020
Japan	2016190879	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)	2010107689

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

Introduction to ZERVIATE

ZERVIATE is a groundbreaking eye drop formulation of the antihistamine cetirizine, known for its efficacy in treating allergic conjunctivitis. This product is particularly significant as it is the first and only eye drop formulation of cetirizine, making it a unique solution in the ophthalmology market[1].

Market Need and Target Audience

ZERVIATE fills a critical medical gap, especially in the treatment of allergic conjunctivitis in toddlers and preschoolers. This demographic is often underserved due to the lack of suitable formulations, making ZERVIATE a vital addition to the market. The product's approval in China and its planned distribution in Southeast Asia highlight its potential to benefit a vast number of children in these regions[1].

Licensing and Distribution

ZERVIATE is exclusively licensed to Ocumension Therapeutics for development and commercialization in China and the majority of Southeast Asian markets. This partnership is crucial as Ocumension plans to manufacture ZERVIATE in its state-of-the-art facility in Suzhou, China, and will leverage its extensive network of national and provincial distribution partners to promote the product[1].

Financial Projections and Milestones

Nicox, the company behind ZERVIATE, stands to benefit significantly from the product's commercial success. Nicox may receive sales milestones of up to $17.2 million, along with royalties ranging from 5% to 9% of the net sales of ZERVIATE by Ocumension. This financial arrangement underscores the potential for substantial revenue generation for Nicox[1].

Market Size and Growth

The global allergic conjunctivitis market, within which ZERVIATE operates, is projected to grow significantly. As of 2023, the market size was $3.04 billion and is expected to reach $4.96 billion by 2032, exhibiting a CAGR of 5.6% during the forecast period. This growth is driven by increasing prevalence of ocular allergies, new medication launches, and a shift towards over-the-counter (OTC) medications[4].

Competitive Landscape

The allergic conjunctivitis market is dominated by key players such as Allergan (AbbVie Inc.), Bausch & Lomb, and Alcon. However, the entry of new players and the launch of generic versions of existing drugs by companies like Sun Pharmaceuticals and Alembic Pharmaceuticals Limited are expected to intensify competition. ZERVIATE, with its unique formulation, positions itself as a competitive offering in this market[4].

Regional Market Dynamics

The approval of ZERVIATE in China and its planned distribution in Southeast Asia are strategic moves to tap into these growing markets. The Asia-Pacific region, including China, is expected to see significant growth due to increasing healthcare spending and a rising awareness of ocular health. This regional focus is crucial for the product's success and for Nicox's financial trajectory[1][3].

Manufacturing and Distribution Strategy

Ocumension's state-of-the-art manufacturing facility in Suzhou, China, will play a pivotal role in ensuring the quality and supply of ZERVIATE. The extensive distribution network of Ocumension, including national and provincial partners, will facilitate widespread availability of the product, which is essential for capturing market share[1].

Regulatory Approvals and Compliance

The approval of ZERVIATE in China is a significant milestone, indicating compliance with regulatory standards. This approval sets a precedent for potential approvals in other Southeast Asian markets, further expanding the product's reach and market potential[1].

Financial Performance of Nicox

Nicox's financial health is closely tied to the success of its products, including ZERVIATE. The company's recent successful financing and the fact that Ocumension is now its principal shareholder highlight the financial stability and potential for growth. The royalties and milestones from ZERVIATE will contribute to Nicox's revenue, supporting its ongoing research and development efforts, such as the development of NCX 470 for glaucoma treatment[1].

Key Takeaways

• Unique Formulation: ZERVIATE is the first and only eye drop formulation of cetirizine, addressing a significant medical need.
• Market Potential: The product is licensed exclusively to Ocumension for China and Southeast Asia, with potential sales milestones and royalties for Nicox.
• Growth Market: The allergic conjunctivitis market is projected to grow to $4.96 billion by 2032, driven by increasing prevalence and new medication launches.
• Competitive Landscape: ZERVIATE competes in a market dominated by major players but has a unique selling proposition.
• Regional Focus: The product's approval and distribution in China and Southeast Asia are strategic for capturing growing markets.

FAQs

Q: What is ZERVIATE and what makes it unique? A: ZERVIATE is the first and only eye drop formulation of the antihistamine cetirizine, designed to treat allergic conjunctivitis, particularly in toddlers and preschoolers.

Q: Who is responsible for the commercialization of ZERVIATE in China and Southeast Asia? A: Ocumension Therapeutics is exclusively licensed to develop and commercialize ZERVIATE in these regions.

Q: What are the potential financial benefits for Nicox from ZERVIATE? A: Nicox may receive sales milestones of up to $17.2 million and royalties ranging from 5% to 9% of the net sales of ZERVIATE.

Q: How does ZERVIATE fit into the broader allergic conjunctivitis market? A: ZERVIATE operates in a market projected to grow to $4.96 billion by 2032, driven by increasing prevalence of ocular allergies and new medication launches.

Q: Where will ZERVIATE be manufactured? A: ZERVIATE will be manufactured in Ocumension’s state-of-the-art facility in Suzhou, China.

Cited Sources

1. Nicox Announces Approval of ZERVIATE in China - BioSpace
2. Zevra Therapeutics Reports Second Quarter 2024 Financial Results - Zevra Therapeutics
3. Cetirizine Hydrochloride Market Key Players, Sales, Demand - BioSpace
4. Allergic Conjunctivitis Market Size, Share & Growth [2032] - Fortune Business Insights

Last updated: 2024-12-18