ZYRTEC ALLERGY Drug Patent Profile

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

Zyrtec Allergy is a drug marketed by J And J Consumer Inc and is included in two NDAs.

The generic ingredient in ZYRTEC ALLERGY 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 Zyrtec Allergy

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

Summary for ZYRTEC ALLERGY

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	30
Patent Applications:	2,616
What excipients (inactive ingredients) are in ZYRTEC ALLERGY?	ZYRTEC ALLERGY excipients list
DailyMed Link:	ZYRTEC ALLERGY at DailyMed

Recent Clinical Trials for ZYRTEC ALLERGY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Emory University	Phase 4
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 1
Indiana University	Phase 4

See all ZYRTEC ALLERGY clinical trials

Pharmacology for ZYRTEC ALLERGY

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

US Patents and Regulatory Information for ZYRTEC ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022578-001	Sep 3, 2010		OTC	Yes	Yes
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-003	Nov 16, 2007		DISCN	Yes	No
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-004	Nov 16, 2007		OTC	Yes	Yes

International Patents for ZYRTEC ALLERGY

See the table below for patents covering ZYRTEC ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	44082
Bosnia and Herzegovina	97198
Spain	521548
Denmark	155796
Norway	820297
Finland	820318

Supplementary Protection Certificates for ZYRTEC ALLERGY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ZYRTEC ALLERGY Market Analysis and Financial Projection Experimental

Zyrtec Allergy Market Dynamics and Financial Trajectory

Overview of Zyrtec Allergy

Zyrtec, also known by its generic name cetirizine hydrochloride, is a widely used antihistamine for treating allergic reactions and symptoms. Here’s a detailed look at the market dynamics and financial trajectory of Zyrtec Allergy.

Market Drivers

Increasing Allergy Prevalence

The global increase in allergy prevalence, driven by rising environmental pollution and lifestyle changes, significantly boosts the demand for effective antihistamines like Zyrtec. This trend is expected to continue, driving market growth[1][3].

Expansion of Over-the-Counter Availability

Regulatory approvals that expand over-the-counter access to Zyrtec in various regions have made the medication more accessible to consumers, enhancing market penetration. This shift has been particularly beneficial in regions with well-established healthcare infrastructures[1].

Advancements in Drug Formulations

Innovations leading to the development of longer-lasting and faster-acting formulations of Zyrtec have enhanced its appeal and market share. These advancements cater to consumer preferences for quick and effective relief from allergy symptoms[1].

Increased Healthcare Spending

Rising healthcare awareness and spending have led more individuals to seek effective solutions for allergy management, favoring the growth of the Zyrtec market. This trend is particularly pronounced in regions with high healthcare spending and extensive availability of over-the-counter allergy medications[1].

Regional Performance

North America

North America, particularly the U.S., dominates the Zyrtec market due to high allergy prevalence and a well-established healthcare infrastructure. The region's significant healthcare spending and extensive availability of over-the-counter allergy medications contribute to its leading position[1][3].

Europe

Europe also shows strong market growth driven by increasing allergy rates and supportive healthcare policies. Major pharmaceutical companies in regions like Germany and the UK focus on R&D activities, further contributing to the robust market in Europe[1].

Asia Pacific

The Asia Pacific region is experiencing rapid market expansion due to increasing urbanization and air quality concerns. Countries like China and India are witnessing a surge in demand for allergy treatments, supported by improving healthcare access and rising public health awareness[1].

Financial Performance

Historical Context

In the past, Zyrtec's financial performance was significantly impacted by the loss of U.S. exclusivity. For instance, Pfizer reported a decline in revenues from Zyrtec in 2008 after the loss of exclusivity, which resulted in a $549 million decrease in revenues compared to the previous year[2].

Current Market Size and Growth

The human antihistamine drug market, which includes Zyrtec, 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%[3].

Consumer Spending and Preferences

Consumer spending on allergy medications is substantial, with 64% of U.S. households purchasing allergy medications in the past 12 months, spending an average of almost $58 per household. Zyrtec, along with other brand names like Claritin and Equate, captures a significant share of this spend[4].

Competitive Landscape

Market Share and Competition

Second-generation antihistamines, which include Zyrtec, hold over 62.7% of the market share due to their improved safety profiles and reduced sedative effects. Over-the-counter (OTC) drugs, which Zyrtec is often available as, lead with a 60.7% market share, reflecting consumer preference for accessible, non-prescription solutions[3].

Brand Loyalty and Advertising

Advertising plays a crucial role in maintaining brand loyalty. For example, 17% of allergy medication buyers are more likely to consider a brand after seeing ads. Zyrtec, along with other prominent brands, benefits from intensive marketing and educational campaigns that increase consumer awareness and trust[4].

Challenges and Restraining Factors

Competition from Alternative Therapies

The availability of numerous alternative allergy treatments, including newer antihistamines and holistic approaches, can limit the growth of the Zyrtec market. Consumers increasingly explore different options for managing their allergies, which can divert demand away from traditional antihistamines[1].

Side Effects and Drug Resistance

Potential side effects and the development of resistance to antihistamines can deter long-term use and affect patient adherence. These factors can impact the overall market growth and consumer trust in Zyrtec and similar medications[1].

Regulatory Challenges

Stringent regulations and slow approval processes in certain regions can delay market entry and affect growth dynamics. These regulatory hurdles can limit the expansion of Zyrtec into new geographic markets and hinder the introduction of new formulations[1].

Opportunities for Growth

Increasing Demand for Fast-Acting Allergy Medications

As consumers seek quick relief from allergy symptoms, there is a growing opportunity for Zyrtec formulations that offer rapid onset of action. This demand can drive innovation and market growth[1].

Expansion into New Geographic Markets

Entry into emerging markets with underdeveloped allergy medication sectors presents significant growth potential. Regions experiencing urbanization and increased allergy prevalence, such as China and India, offer lucrative opportunities for Zyrtec[1].

Development of Combination Therapies

Combining Zyrtec with other therapeutic agents to treat multiple symptoms can offer a competitive edge and meet broader consumer needs. This approach can enhance the market share and appeal of Zyrtec[1].

Partnerships and Collaborations

Strategic partnerships between pharmaceutical companies and local distributors in various regions can enhance market reach and penetration. These collaborations can be particularly effective in emerging markets where healthcare infrastructure is improving[1].

Key Takeaways

• The Zyrtec market is driven by increasing allergy prevalence, expansion of over-the-counter availability, and advancements in drug formulations.
• North America, particularly the U.S., leads in the adoption of Zyrtec due to high allergy prevalence and well-established healthcare infrastructure.
• The market faces challenges from alternative therapies, side effects, and regulatory hurdles.
• Opportunities for growth include increasing demand for fast-acting medications, expansion into new geographic markets, development of combination therapies, and strategic partnerships.

FAQs

What are the primary drivers of the Zyrtec market?

The primary drivers include increasing allergy prevalence, expansion of over-the-counter availability, advancements in drug formulations, and increased healthcare spending.

How does the regional performance of Zyrtec vary?

Zyrtec dominates in North America, particularly the U.S., due to high allergy prevalence and well-established healthcare infrastructure. Europe and the Asia Pacific region also show strong market growth driven by increasing allergy rates and improving healthcare access.

What are the challenges facing the Zyrtec market?

Challenges include competition from alternative therapies, potential side effects and drug resistance, and regulatory hurdles.

What opportunities exist for the growth of Zyrtec?

Opportunities include increasing demand for fast-acting allergy medications, expansion into new geographic markets, development of combination therapies, and strategic partnerships.

How does consumer spending impact the Zyrtec market?

Consumer spending is significant, with 64% of U.S. households purchasing allergy medications, and Zyrtec captures a substantial share of this spend due to its brand recognition and marketing efforts.

Sources

1. Cetirizine Hydrochloride Market Trends, Drivers, and Forecasts up to 2032 - MarketResearch.biz
2. Pfizer Reports Third-Quarter 2008 Results - Pfizer
3. Human Antihistamine Drug Market Size | CAGR OF 9.9% - Market.US
4. 64% of U.S. Households Buy Seasonal Allergy Medication - Numerator
5. Comparison Of Efficacy Of Once Daily Zyrtec® (cetirizine), Cetrizin ... - Journal of Allergy and Clinical Immunology