XYZAL Drug Patent Profile

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

Xyzal is a drug marketed by Chattem Sanofi and is included in four NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in XYZAL 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

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

Summary for XYZAL

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	66
Patent Applications:	163
Drug Prices:	Drug price information for XYZAL
Drug Sales Revenues:	Drug sales revenues for XYZAL
What excipients (inactive ingredients) are in XYZAL?	XYZAL excipients list
DailyMed Link:	XYZAL at DailyMed

See drug prices for XYZAL

See drug sales revenues for XYZAL

Paragraph IV (Patent) Challenges for XYZAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XYZAL	Oral Solution	levocetirizine dihydrochloride	0.5 mg/mL	022157	1	2009-01-14
XYZAL	Tablets	levocetirizine dihydrochloride	5 mg	022064	1	2007-12-17

US Patents and Regulatory Information for XYZAL

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	levocetirizine dihydrochloride	SOLUTION;ORAL	022157-001	Jan 28, 2008		DISCN	Yes	No
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	TABLET;ORAL	209089-001	Jan 31, 2017		OTC	Yes	Yes
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007		DISCN	Yes	No
Chattem Sanofi	XYZAL ALLERGY 24HR	levocetirizine dihydrochloride	SOLUTION;ORAL	209090-001	Jan 31, 2017		OTC	Yes	Yes			Y

Expired US Patents for XYZAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	SOLUTION;ORAL	022157-001	Jan 28, 2008
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064-001	May 25, 2007

International Patents for XYZAL

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

Country	Patent Number	Title	Estimated Expiration
Germany	10199031
European Patent Office	0950412
Netherlands	300085
Denmark	154078
Norway	155805

Supplementary Protection Certificates for XYZAL

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	SPC/GB01/052	United Kingdom		SPC/GB01/052:, EXPIRES: 20070205
0663828	CA 2002 00006	Denmark
0663828	0490019-7	Sweden		PRODICT NAME: LEVO-CETIRIZIN OCH SALTER DAERAV; NAT REGISTRATION NO/DATE: 20039 20040423; FIRST REGISTRATION: DE 49903.00.00 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Xyzal

Introduction

Xyzal, an oral antihistamine containing the active ingredient levocetirizine dihydrochloride, has been a significant player in the allergy medication market since its approval. Here, we delve into the market dynamics and financial trajectory of Xyzal, highlighting its key milestones, market performance, and future prospects.

Approval and Launch

Xyzal was first approved by the U.S. FDA in 2007 for prescription use, marking a crucial milestone for its manufacturer, UCB, and its marketing partner, Sanofi-Aventis. This approval followed a lengthy process, including securing a U.S. marketing partner after initial plans with Pfizer fell through[3].

Market Entry and Competition

Upon its launch, Xyzal faced stiff competition from established allergy medications, including its predecessor Zyrtec. However, Xyzal's steady sales growth in Europe and other markets indicated strong potential for the U.S. market. The drug's ability to offer 24-hour relief from allergy symptoms positioned it favorably against other antihistamines[3].

Transition to Over-the-Counter (OTC) Status

A significant turning point for Xyzal came in 2017 when the FDA approved it for OTC use. This switch allowed Xyzal to be sold without a prescription, expanding its reach to a broader consumer base. The approval included two formulations: 5 mg tablets for ages 6 and older, and a 0.5 mg/mL oral solution for ages 2 and older[4].

Market Performance

Sales Growth

Xyzal's sales have shown consistent growth. In 2006, Xyzal's sales grew by 13% year-over-year, outpacing the slower growth of its predecessor Zyrtec, which had been genericized and saw only a 2% increase[3]. The transition to OTC status further boosted sales, as it became more accessible to consumers.

Financial Impact

The approval and subsequent sales of Xyzal have contributed significantly to the financial performance of its manufacturers. For UCB, the approval and launch of Xyzal were critical, especially as the company prepared for its takeover of Schwarz Pharma. The revenue generated from Xyzal helped offset delays in other pipeline compounds, such as Cimzia[3].

For Sanofi, Xyzal's inclusion in its consumer healthcare portfolio has been a success. In Q4 2020, Sanofi's U.S. consumer healthcare sales, which include allergy medications like Xyzal and Allegra, increased by 2.4% to €238 million. This growth reflects the strong market presence of these products[5].

Market Dynamics

Consumer Preference

Xyzal's approval for OTC use has aligned with consumer preferences for accessible, non-prescription solutions. This shift is part of a broader trend where consumers increasingly seek convenient and self-managed healthcare options. The human antihistamine drug market, in general, has seen a preference for OTC drugs, with over 60.7% market share in 2023[1].

Competitive Landscape

The allergy medication market is highly competitive, with several well-established brands. However, Xyzal's proven safety and efficacy profile, along with its 24-hour relief, have helped it carve out a significant market share. The drug competes with other popular antihistamines like Allegra and Zyrtec, but its unique selling points have allowed it to maintain a strong position[3][4].

Regional Performance

Xyzal's performance varies by region, but it has been particularly strong in North America. The region's high incidence of allergic conditions and proactive approach to healthcare have contributed to the drug's success. North America secured a substantial 37.2% market share in the human antihistamine drug market in 2023, reflecting a strong market presence[1].

Safety and Efficacy

Xyzal has a well-established safety and efficacy profile, which has been a key factor in its market success. However, it does come with certain contraindications, such as warnings against use in patients with end-stage renal disease and pediatric patients with impaired renal function. Additionally, there are general warnings about engaging in hazardous occupations requiring complete mental alertness and motor coordination after taking Xyzal[3][4].

Future Prospects

Market Growth

The human antihistamine drug market, including Xyzal, is expected to grow significantly. The market is projected to reach approximately USD 706.2 million by 2033, growing at a CAGR of 9.9% from 2024 to 2033. This growth is driven by increasing global allergy prevalence rates, innovations in drug research and development, and expansions of healthcare infrastructure[1].

Continued Innovation

The ongoing innovation in allergy treatments and the potential for new formulations or combinations of antihistamines will continue to shape the market. Xyzal's success has demonstrated the importance of continuous R&D and strategic partnerships in maintaining market relevance.

Key Takeaways

• Approval and Launch: Xyzal was approved by the FDA in 2007 for prescription use and later transitioned to OTC status in 2017.
• Market Performance: Xyzal has shown consistent sales growth, contributing significantly to the financial performance of its manufacturers.
• Consumer Preference: The drug aligns with consumer preferences for accessible, non-prescription solutions.
• Competitive Landscape: Xyzal competes in a highly competitive market but maintains a strong position due to its safety and efficacy profile.
• Regional Performance: The drug has been particularly strong in North America.
• Future Prospects: The human antihistamine drug market, including Xyzal, is expected to grow significantly, driven by increasing allergy prevalence and healthcare infrastructure expansions.

FAQs

What is Xyzal, and how does it work?

Xyzal is an oral antihistamine containing levocetirizine dihydrochloride, offering 24-hour relief from symptoms associated with seasonal and year-round allergies.

When was Xyzal approved for OTC use in the U.S.?

Xyzal was approved for OTC use in the U.S. in February 2017.

What are the key contraindications for Xyzal?

Xyzal has contraindications for patients with end-stage renal disease and pediatric patients with impaired renal function. There are also general warnings against engaging in hazardous occupations requiring complete mental alertness and motor coordination after taking Xyzal.

How has Xyzal performed in the market?

Xyzal has shown consistent sales growth, particularly after its transition to OTC status. It has contributed significantly to the financial performance of its manufacturers, UCB and Sanofi.

What is the projected growth of the human antihistamine drug market?

The human antihistamine drug market is projected to reach approximately USD 706.2 million by 2033, growing at a CAGR of 9.9% from 2024 to 2033.

What factors drive the growth of the human antihistamine drug market?

The growth is driven by increasing global allergy prevalence rates, innovations in drug research and development, and expansions of healthcare infrastructure.

Sources

1. Market.us: Human Antihistamine Drug Market Size | CAGR OF 9.9% [https://market.us/report/human-antihistamine-drug-market/]
2. GSK: Full year and fourth quarter 2021 - GSK [https://www.gsk.com/media/7377/fy-2021-results-announcement.pdf]
3. S&P Global: Breakthrough for UCB as Xyzal Finally Approved by U.S. FDA [https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=106598036]
4. PR Newswire: Sanofi's Xyzal® Allergy 24HR Approved for Over-the-Counter Use in the United States [https://www.prnewswire.com/news-releases/sanofis-xyzal-allergy-24hr-approved-for-over-the-counter-use-in-the-united-states-300400145.html]
5. Sanofi: Sanofi delivered close to double-digit Q4 2020 business EPS(1) [https://www.sanofi.com/en/media-room/press-releases/2021/2021-02-05-06-30-00-2170436]