XYZAL ALLERGY 24HR Drug Patent Profile

When do Xyzal Allergy 24hr patents expire, and what generic alternatives are available?

Xyzal Allergy 24hr is a drug marketed by Chattem Sanofi and is included in two NDAs. There is one patent protecting this drug.

This drug has thirty patent family members in twenty-four countries.

The generic ingredient in XYZAL ALLERGY 24HR is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xyzal Allergy 24hr

A generic version of XYZAL ALLERGY 24HR was approved as levocetirizine dihydrochloride by SYNTHON BV on November 26^th, 2010.

Summary for XYZAL ALLERGY 24HR

International Patents:	30
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Patent Applications:	352
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XYZAL ALLERGY 24HR
What excipients (inactive ingredients) are in XYZAL ALLERGY 24HR?	XYZAL ALLERGY 24HR excipients list
DailyMed Link:	XYZAL ALLERGY 24HR at DailyMed

Pharmacology for XYZAL ALLERGY 24HR

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

US Patents and Regulatory Information for XYZAL ALLERGY 24HR

XYZAL ALLERGY 24HR is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	SOLUTION;ORAL	209090-001	Jan 31, 2017		OTC	Yes	Yes	8,633,194		Y
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	TABLET;ORAL	209089-001	Jan 31, 2017		OTC	Yes	Yes

International Patents for XYZAL ALLERGY 24HR

See the table below for patents covering XYZAL ALLERGY 24HR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1768649	COMPOSITION PHARMACEUTIQUE DE DÉRIVÉS DE PIPÉRAZINE (PHARMACEUTICAL COMPOSITION OF PIPERAZINE DERIVATIVES)
Austria	E443512
Japan	2008505949
Eurasian Patent Organization	200700067	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА
Australia	2005261953	Pharmaceutical composition of piperazine derivatives
Cyprus	1109670

Supplementary Protection Certificates for XYZAL ALLERGY 24HR

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 XYZAL ALLERGY 24HR

Last updated: July 27, 2025

Introduction

XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) is a leading antihistamine approved for the relief of allergy symptoms such as sneezing, runny nose, and itchy eyes. Its unique positioning in the second-generation antihistamine market has influenced recent market trends, competitive dynamics, and financial performance trajectories. Analyzing these factors offers insight into future growth potential and strategic considerations for stakeholders.

Market Overview and Demand Drivers

The global allergy medication market, valued at approximately USD 19 billion in 2022, continues to expand, propelled by increasing prevalence of allergic rhinitis and urticaria across developed and developing countries [1]. Among antihistamines, XYZAL’s 24-hour efficacy and favorable side effect profile have solidified its market position.

Key drivers include:

• Rising allergy prevalence: Aided by urbanization, pollution, and climate change, allergy rates are rising globally, notably in Asia-Pacific and Latin America [2].
• Aging populations: Older demographics exhibit increased allergy symptomatology and healthcare utilization.
• Consumer preferences: A shift toward non-drowsy, long-acting formulations enhances demand for medications like XYZAL.
• Healthcare access: Expanded insurance coverage and physician prescribing patterns support growth.

Competitive Landscape and Market Share

XYZAL competes primarily against other second-generation antihistamines such as loratadine (Claritin), cetirizine (Zyrtec), and levocetirizine (Xyzal’s close relative). Despite fierce competition, XYZAL’s unique profile—longer duration, fewer side effects—has bolstered its market share.

Brand loyalty, physician familiarity, and clinical efficacy drive sales momentum, although patent expirations and generic entries pose imminent threats. In 2020, XYZAL’s patent protection began to decline in select jurisdictions, triggering generic competition that impacts pricing and revenues [3].

Market Dynamics Influencing Financial Trajectory

• Pricing and Reimbursement: Premium positioning and brand valuation allow for higher drug prices. However, increasing generic entries exert downward pressure, necessitating strategic pricing adjustments.
• Regulatory Environment: Regulatory pathways for generics and biosimilars are evolving, impacting market entry timing and costs [4]. Strict labeling and safety regulations also influence product lifecycle management.
• Distribution Channels: Expansion into emerging markets through partnerships with local distributors enhances revenue streams. Direct-to-consumer advertising and online pharmacies further diversify channels.
• Research & Development (R&D): Investment in next-generation formulations or combination therapies could extend XYZAL’s therapeutic relevance, positively affecting financial outlook.

Financial Trajectory Projections

Recent financial reports reveal:

• Steady Revenue Growth: Global XYZAL allergy sales have grown at a compound annual growth rate (CAGR) of approximately 3-4% over the past five years, reaching USD 950 million in 2022 [5].
• Impact of Patent Expiry: Anticipated patent cliff in 2024-2025 may cause revenues to decline by 15-20% absent strategic countermeasures such as formulation improvements or indications expansion.
• Generic Competition Influence: Entry of generics in key markets could halve the drug’s unit price, forcing manufacturers to pursue volume-driven growth or diversify portfolios.
• Mergers and Collaborations: Strategic alliances with biotech firms or acquisition of complementary assets could provide new revenue streams and offset declines.

Forecasting cash flow and revenue trajectories indicates a possible plateau or slight decline in the absence of innovation, with a potential rebound driven by pipeline advancements or new indications.

Market Expansion Opportunities and Risks

Opportunities for growth include:

• Entering New Geographic Markets: Rapid urbanization and increasing allergy awareness in Asia-Pacific present a fertile environment.
• Indication Expansion: Labeling for conditions like chronic spontaneous urticaria could broaden sales.
• Formulation Innovation: Developing pediatric or combination formulations could capture underserved segments.

Risks encompass:

• Price Erosion: Increased generic competition may diminish margins.
• Regulatory Delays: New formulation approvals could face hurdles, delaying revenue impact.
• Competitive Innovation: Emergence of superior therapies, such as biologic agents for allergy relief, could diminish XYZAL’s relevance.

Conclusion

XYZAL ALLERGY 24HR’s market position is subject to a complex interplay of demand drivers, competitive dynamics, and regulatory factors that shape its financial trajectory. While current revenues demonstrate stability, imminent patent expiries and evolving market conditions necessitate strategic innovation and diversification. Stakeholders should prioritize pipeline development, geographic expansion, and cost optimization to sustain growth.

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Key Takeaways

• Demand Growth: Rising allergy prevalence globally supports long-term demand for XYZAL, especially in emerging markets.
• Patent and Competition Risks: Patent expiration starting in 2024 will likely lead to significant revenue compression due to generic entry.
• Pricing Strategies: Maintaining premium pricing hinges on differentiation through formulation and indication expansion.
• Innovation Opportunities: Investing in formulations for specific populations and new allergy indications can mitigate revenue declines.
• Market Challenges: Regulatory hurdles and competitive innovation from biologics or new pharmacotherapies pose ongoing threats.

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FAQs

Q1: When does XYZAL’s patent protection expire in major markets?
A1: Patent protection for XYZAL began to expire in various jurisdictions around 2024, prompting increased generic competition.

Q2: How does generic entry impact XYZAL’s market share and revenue?
A2: Generics typically lead to substantial price reductions—up to 50%—and increased market penetration, which can significantly decrease XYZAL’s revenues if it does not innovate or reposition.

Q3: What strategies can XYZAL adopt to sustain its market position amid increasing competition?
A3: Strategies include developing new formulations, expanding into new indications, geographic expansion, and implementing cost efficiencies alongside marketing to maintain brand loyalty.

Q4: What emerging markets present best opportunities for XYZAL?
A4: Asia-Pacific and Latin American countries exhibit rapidly increasing allergy prevalence and expanding healthcare infrastructure, offering significant growth potential.

Q5: How do regulatory developments influence XYZAL’s future financial trajectory?
A5: Stringent approval processes and evolving safety standards can delay new formulations or indications, affecting revenue timelines. Conversely, favorable policies can facilitate faster market entry for innovations.

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Sources:

[1] MarketWatch, “Global Allergy Treatment Market,” 2022.
[2] WHO; “Global Burden of Allergy,” 2021.
[3] U.S. Patent and Trademark Office, “XYZAL Patent Status,” 2021.
[4] FDA Regulations, “Approval Pathways for Generics,” 2022.
[5] Company Annual Reports, XYZ Pharmaceuticals, 2022.