ZYRTEC Drug Patent Profile

Which patents cover Zyrtec, and when can generic versions of Zyrtec launch?

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

The generic ingredient in ZYRTEC is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyrtec

A generic version of ZYRTEC was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

Summary for ZYRTEC

US Patents:	0
Applicants:	1
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	30
Patent Applications:	2,616
Drug Sales Revenues:	Drug sales revenues for ZYRTEC
What excipients (inactive ingredients) are in ZYRTEC?	ZYRTEC excipients list
DailyMed Link:	ZYRTEC at DailyMed

See drug sales revenues for ZYRTEC

Recent Clinical Trials for ZYRTEC

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 clinical trials

Paragraph IV (Patent) Challenges for ZYRTEC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC	Syrup	cetirizine hydrochloride	5 mg/5 mL	020346	1	2007-03-19

US Patents and Regulatory Information for ZYRTEC

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	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996		DISCN	No	No
J And J Consumer Inc	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007		OTC	Yes	Yes
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET;ORAL	019835-004	Nov 16, 2007		OTC	Yes	Yes
J And J Consumer Inc	ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022578-001	Sep 3, 2010		OTC	Yes	Yes

Expired US Patents for ZYRTEC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996

International Patents for ZYRTEC

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

Country	Patent Number	Title	Estimated Expiration
Denmark	44082
Bosnia and Herzegovina	97198
Spain	521548
Denmark	155796

Supplementary Protection Certificates for ZYRTEC

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zyrtec

Overview of Zyrtec

Zyrtec, also known as cetirizine hydrochloride, is a widely used antihistamine for the treatment of allergic conditions such as hay fever, allergies, and urticaria. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global Zyrtec market has shown significant growth in recent years. As of 2021, the market size was valued at approximately USD 1.675 billion and is expected to expand at a Compound Annual Growth Rate (CAGR) of 5.25% from 2022 to 2027, reaching USD 2.277 billion by 2027[4].

Regional Analysis

The market is geographically segmented into several key regions, each with its own growth prospects:

• North America: This region is a significant market for Zyrtec due to high incidence rates of allergic conditions and robust healthcare infrastructure.
• Europe: Europe also represents a substantial market, driven by stringent regulatory frameworks and high consumer trust in established brands.
• Asia Pacific: This region is expected to drive future growth, fueled by increasing healthcare expenditure, growing awareness about allergy management, and improving healthcare infrastructure[3][4].
• Latin America, Middle East, and Africa: These regions present emerging market opportunities due to growing healthcare needs and increasing access to medications.

Market Segmentation

The Zyrtec market can be segmented by type and application:

• By Type: This includes various formulations such as tablets, syrups, and intravenous solutions.
• By Application: Zyrtec is used for treating allergic rhinitis, urticaria, and other allergic conditions[4].

Competitive Landscape

The competitive landscape of the Zyrtec market is characterized by several key players, including Johnson & Johnson, Pfizer, and other generic manufacturers. The market concentration rate is moderate, with top players holding significant market shares. Mergers and acquisitions, as well as the emergence of new market trends, continue to shape the competitive scenario[4].

Market Drivers

Several factors drive the growth of the Zyrtec market:

• Increasing Prevalence of Allergic Disorders: The rising incidence of allergic conditions globally is a major driver.
• Advancements in Healthcare Infrastructure: Improvements in healthcare facilities and access to medications in emerging markets.
• Availability of Generic Versions: The availability of generic cetirizine hydrochloride has made the drug more accessible and affordable[3][4].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Threat of New Medications: The development of new antihistamines and other allergy treatments could potentially slow the growth rate of Zyrtec.
• Stringent Regulatory Frameworks: Compliance with regulatory standards, particularly in regions like Europe, can pose challenges for market growth[3].

Financial Trajectory

The financial performance of Zyrtec is closely tied to the overall pharmaceutical market trends:

• Revenue Growth: The global cetirizine hydrochloride market is projected to grow from USD 6.213 billion in 2023 to USD 7.236 billion by 2030, with a CAGR of 2.2%. By 2034, the market is expected to reach USD 8.0 billion, growing at a CAGR of 2.6% from 2024 to 2034[3].
• Budget Impact: In emergency department settings, the adoption of intravenous cetirizine hydrochloride has shown a positive budget impact, primarily due to reduced operational costs and increased revenue from treating additional patients[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the Zyrtec market:

• Supply Chain Disruptions: Initial disruptions affected the supply chain, but most manufacturers have since adapted.
• Increased Demand: The pandemic has highlighted the importance of healthcare infrastructure, leading to increased demand for essential medications like Zyrtec[4].

Consumer Preference Analysis

Consumer preferences play a crucial role in the market dynamics of Zyrtec:

• Brand Loyalty: Established brands like Zyrtec enjoy high consumer trust due to their proven safety and effectiveness.
• Generic Options: The availability of generic versions has increased consumer options, making the drug more accessible[4].

Technological Trends

Advancements in technology are influencing the Zyrtec market:

• Innovative Formulations: New formulations such as intravenous solutions are expanding the market.
• Digital Health: The integration of digital health solutions is improving patient compliance and treatment outcomes[3].

Regulatory Frameworks

Regulatory compliance is critical for the Zyrtec market:

• Stringent Standards: Regions like Europe have stringent regulatory standards that ensure the quality and safety of the drug.
• Compliance Benefits: Compliance with these regulations maintains consumer trust and ensures market stability[3].

Emerging Markets

Emerging markets present significant opportunities for growth:

• Asia Pacific, Latin America, Middle East, and Africa: These regions are expected to drive future growth due to increasing healthcare expenditure and improving healthcare infrastructure[3][4].

Key Takeaways

• The global Zyrtec market is valued at USD 1.675 billion in 2021 and is expected to grow to USD 2.277 billion by 2027.
• The market is driven by the increasing prevalence of allergic disorders, advancements in healthcare infrastructure, and the availability of generic versions.
• North America, Europe, and the Asia Pacific are key regions driving market growth.
• The market faces challenges from new medication developments and stringent regulatory frameworks but presents significant opportunities in emerging markets.
• The adoption of Zyrtec in emergency department settings has shown a positive budget impact.

FAQs

What is the current market size of Zyrtec?

The global Zyrtec market was valued at approximately USD 1.675 billion in 2021[4].

What is the projected growth rate of the Zyrtec market?

The market is expected to grow at a CAGR of 5.25% from 2022 to 2027[4].

Which regions are driving the growth of the Zyrtec market?

North America, Europe, and the Asia Pacific are the key regions driving market growth due to their high incidence of allergic conditions and robust healthcare infrastructure[3][4].

What are the main drivers of the Zyrtec market?

The main drivers include the increasing prevalence of allergic disorders, advancements in healthcare infrastructure, and the availability of generic versions of the drug[3][4].

How has the COVID-19 pandemic impacted the Zyrtec market?

The pandemic has caused initial supply chain disruptions but has also highlighted the importance of healthcare infrastructure, leading to increased demand for essential medications like Zyrtec[4].

Cited Sources:

1. Cognitivemarketresearch.com: Zyrtec Market Report 2024 (Global Edition)
2. Johnson & Johnson: Johnson Reports 2020 Fourth-Quarter and Full Year Results
3. DrugPatentWatch: Cetirizine hydrochloride - Generic Drug Details
4. Globenewswire.com: Zyrtec Market Will Turn over USD 1675.45 to success Revenue to Cross USD 2277.25 in 2022 to 2027
5. Pfizer: Pfizer Reports Third-Quarter 2008 Results