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-one 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 PHARMS 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:	66
Patent Applications:	150
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
Eurasian Patent Organization	012463	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА (PHARMACEUTICAL COMPOSITION CONTAINING PIPERAZINE DERIVATIVES)
Japan	2008505949
World Intellectual Property Organization (WIPO)	2006005507
Eurasian Patent Organization	200700067	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНЫЕ ПИПЕРАЗИНА
Taiwan	I304339
Portugal	1768649

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

XYZAL ALLERGY 24HR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xyzal Allergy 24HR

Introduction to Xyzal Allergy 24HR

Xyzal Allergy 24HR, an oral antihistamine containing the active ingredient levocetirizine dihydrochloride, was approved by the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) use in February 2017. This approval marked a significant milestone in the allergy treatment market, offering consumers a reliable and effective solution for seasonal and year-round allergies[1][5].

Market Context: Allergy Treatment

The global allergy treatment market is experiencing robust growth driven by several key factors. These include increasing environmental pollution, a rise in the number of patients with various types of allergies, and changing lifestyles. The market is estimated to grow at a Compound Annual Growth Rate (CAGR) of 6.9%, reaching a value of $20.20 billion by 2022[3].

Approval and Availability

The FDA approval of Xyzal Allergy 24HR includes two formulations: 5 mg tablets for individuals aged 6 years and older, and 0.5 mg/mL oral solution for ages 2 years and older. This broadens the accessibility of the medication, making it a versatile option for a wide range of allergy sufferers[1][5].

Market Impact

The approval of Xyzal Allergy 24HR has significantly impacted the market in several ways:

Expanding Consumer Healthcare Portfolio

Sanofi's consumer healthcare division has strengthened its portfolio with the addition of Xyzal Allergy 24HR. This move follows previous successful Rx-to-OTC switches, such as Allegra Allergy in 2011 and Nasacort Allergy 24HR in 2013. This expansion enhances Sanofi's position in the consumer healthcare market[1].

Consumer Preference

The OTC status of Xyzal Allergy 24HR aligns with consumer preferences for accessible, non-prescription solutions. The human antihistamine drug market, in which Xyzal operates, is dominated by OTC drugs, which hold a 60.7% market share as of 2023[4].

Competitive Landscape

The allergy treatment market is highly competitive, with major players such as Johnson & Johnson, Allergopharma, Sanofi SA, and GlaxoSmithKline PLC. The approval of Xyzal Allergy 24HR positions Sanofi as a key player, particularly in North America, where the company has a strong market presence[3][4].

Financial Trajectory

Market Size and Growth

The human antihistamine drug market, which includes Xyzal Allergy 24HR, is projected to grow significantly. By 2033, the market is expected to reach approximately $706.2 million, up from $274.8 million in 2023, at a CAGR of 9.9%[4].

Regional Performance

North America, where Xyzal Allergy 24HR is approved, is a leading region in the human antihistamine drug market. As of 2023, North America holds a 37.2% market share, driven by factors such as high awareness about allergy management and a proactive approach to healthcare[4].

Revenue Contribution

Given its prescription strength and 24-hour efficacy, Xyzal Allergy 24HR is expected to contribute significantly to Sanofi's revenue in the consumer healthcare segment. The medication's availability without a prescription and its proven safety and efficacy profile are key drivers of its financial performance[1][2].

Key Features and Benefits

• 24-Hour Relief: Xyzal Allergy 24HR provides continuous relief from allergy symptoms such as sneezing, runny nose, itchy, watery eyes, and itchy nose or throat[1][2].
• Full Prescription Strength: Available without a prescription, it offers the same efficacy as prescription-strength antihistamines[2].
• Rapid Relief: The medication provides rapid relief from allergy symptoms, making it a preferred choice for consumers[2].

Consumer Demand and Preferences

The demand for antihistamines, particularly OTC options, is driven by consumer preferences for convenient and effective solutions. The fact that Xyzal Allergy 24HR can be taken at night to prevent morning suffering when pollen levels are highest adds to its appeal[2].

Challenges and Opportunities

While the market for allergy treatments is growing, there are challenges such as increasing competition and the need for continuous innovation. However, these challenges also present opportunities for companies like Sanofi to expand their product portfolios and invest in research and development to meet the evolving needs of allergy sufferers[3][4].

Regional Analysis

• North America: This region is expected to continue its strong performance due to developed healthcare infrastructure, high awareness about allergy management, and a proactive approach to healthcare[4].
• Asia: The Asian market is also booming due to the expanding number of allergy patients, rising disposable income, and increasing awareness of advanced immunotherapy for treating allergies[3].

Conclusion

Xyzal Allergy 24HR has positioned itself as a trusted and effective option in the allergy treatment market. With its FDA approval for OTC use, it has expanded Sanofi's consumer healthcare portfolio and aligned with consumer preferences for accessible, non-prescription solutions. The financial trajectory of Xyzal Allergy 24HR is promising, driven by the growing demand for antihistamines and the medication's proven efficacy and safety profile.

Key Takeaways

• FDA Approval: Xyzal Allergy 24HR was approved for OTC use in February 2017.
• Market Growth: The human antihistamine drug market is expected to grow at a CAGR of 9.9% until 2033.
• Consumer Preference: OTC drugs dominate the market, with Xyzal Allergy 24HR aligning with this preference.
• Regional Performance: North America is a leading region in the human antihistamine drug market.
• Financial Trajectory: Xyzal Allergy 24HR is expected to contribute significantly to Sanofi's revenue in the consumer healthcare segment.

FAQs

Q: What is Xyzal Allergy 24HR, and what is its active ingredient?

A: Xyzal Allergy 24HR is an oral antihistamine containing the active ingredient levocetirizine dihydrochloride, approved for OTC use to relieve symptoms associated with seasonal and year-round allergies.

Q: When was Xyzal Allergy 24HR approved for OTC use?

A: Xyzal Allergy 24HR was approved for OTC use by the FDA in February 2017.

Q: What formulations of Xyzal Allergy 24HR are available?

A: Xyzal Allergy 24HR is available in two formulations: 5 mg tablets for ages 6 years and older, and 0.5 mg/mL oral solution for ages 2 years and older.

Q: How does Xyzal Allergy 24HR fit into Sanofi's consumer healthcare portfolio?

A: The approval of Xyzal Allergy 24HR adds another trusted option to Sanofi's existing portfolio of OTC allergy medications, following previous successful Rx-to-OTC switches like Allegra Allergy and Nasacort Allergy 24HR.

Q: What is the projected growth rate of the human antihistamine drug market?

A: The human antihistamine drug market is projected to grow at a CAGR of 9.9% from 2024 to 2033, reaching approximately $706.2 million by 2033.

Sources

1. PR Newswire: Sanofi's Xyzal® Allergy 24HR Approved for Over-the-Counter Use in the United States.
2. FSA Store: Xyzal 24 Hour Allergy Medicine.
3. Future Market Insights: Allergy Treatment Market Size, Demand, Share & Trends.
4. Market.US: Human Antihistamine Drug Market Size | CAGR OF 9.9%.
5. Drug Discovery Trends: Sanofi's Xyzal Allergy 24HR Approved for OTC Use in the United States.