CETIRIZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for cetirizine hydrochloride and what is the scope of patent protection?

Cetirizine hydrochloride is the generic ingredient in fifteen branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Catalent, Strides Pharma, Harrow Eye, JDP, Actavis Mid Atlantic, Amneal Pharms, Apozeal Pharms, Bajaj, Chartwell Molecular, Lannett Co Inc, Padagis Us, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Teva Pharms, Wockhardt, Aurobindo Pharma, Chartwell Rx, Cypress Pharm, Hetero Labs Ltd Iii, Perrigo R And D, Quagen, Tris Pharma Inc, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Indoco, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, Ipca Labs Ltd, Marksans Pharma, Mylan, Orbion Pharms, Pld Acquisitions, Sun Pharm Inds Ltd, Torrent Pharms Llc, Unichem, Unique, Ivax Sub Teva Pharms, and Ppi-dac, and is included in seventy-eight NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Cetirizine hydrochloride has twenty-eight patent family members in eight countries.

There are twelve drug master file entries for cetirizine hydrochloride. One hundred and fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CETIRIZINE HYDROCHLORIDE

International Patents:	28
US Patents:	9
Tradenames:	15
Applicants:	52
NDAs:	78
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	156
Raw Ingredient (Bulk) Api Vendors:	274
Clinical Trials:	91
Patent Applications:	5,228
What excipients (inactive ingredients) are in CETIRIZINE HYDROCHLORIDE?	CETIRIZINE HYDROCHLORIDE excipients list
DailyMed Link:	CETIRIZINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE

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

Sponsor	Phase
Emory University	Phase 3
CURE Drug Repurposing Collaboratory (CDRC)	Phase 3
Ruijin Hospital	Phase 1/Phase 2

See all CETIRIZINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CETIRIZINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		5MG/5ML	SOLUTION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CETIRIZINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for CETIRIZINE HYDROCHLORIDE

Anti-Allergic Agents

Histamine H1 Antagonists, Non-Sedating

Anatomical Therapeutic Chemical (ATC) Classes for CETIRIZINE HYDROCHLORIDE

R06AE	Piperazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC	Syrup	cetirizine hydrochloride	5 mg/5 mL	020346	1	2007-03-19
CHILDREN'S ZYRTEC HIVES RELIEF	Chewable Tablets	cetirizine hydrochloride	5 mg and 10 mg	021621		2005-03-25

US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE

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	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007		DISCN	Yes	No
Unichem	CETIRIZINE HYDROCHLORIDE HIVES	cetirizine hydrochloride	TABLET;ORAL	078680-001	Jun 26, 2009		DISCN	No	No
Pld Acquisitions	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077946-001	Dec 27, 2007		OTC	No	No
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes	9,993,471
Amneal Pharms	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	SOLUTION;ORAL	090765-001	Oct 7, 2009		OTC	No	No
Jubilant Generics	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	091116-003	Feb 19, 2015		OTC	No	No
Heritage Pharma	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	078615-003	Dec 28, 2007		DISCN	No	No

Expired US Patents for CETIRIZINE HYDROCHLORIDE

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	4,525,358*PED
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007	6,455,533
J And J Consumer Inc	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007	6,455,533
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007	6,455,533
J And J Consumer Inc	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007	6,455,533

International Patents for CETIRIZINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	6893573
Portugal	2408453
Spain	2616703
World Intellectual Property Organization (WIPO)	2010107689
Japan	2016190878	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)
Australia	2010266103	Non-sedating antihistamine injection formulations and methods of use thereof
Japan	2020117545	セチリジンの眼科用製剤および使用方法 (OPHTHALMOLOGIC PREPARATION OF CETIRIZINE AND METHODS OF USE)

Supplementary Protection Certificates for CETIRIZINE HYDROCHLORIDE

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

CETIRIZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cetirizine Hydrochloride

Overview of Cetirizine Hydrochloride

Cetirizine hydrochloride, a second-generation antihistamine, is widely used for treating various allergic conditions, including allergic rhinitis, allergic conjunctivitis, and eczema. It is marketed under brands such as Zyrtec and Aller-Tec, and its popularity stems from its non-sedating properties and minimal side effects[3].

Global Market Size and Growth

As of 2023, the global cetirizine hydrochloride market was valued at approximately USD 6.213 billion. This market is projected to grow at a Compounded Annual Growth Rate (CAGR) of 2.2% to reach USD 7.236 billion by 2030[1].

In a more extended forecast, the market is expected to reach USD 8.0 billion by 2034, growing at a CAGR of 2.6% from 2024 to 2034[3].

Market Drivers

Increasing Prevalence of Allergic Disorders

The rising rates of allergic diseases globally are a significant driver for the cetirizine hydrochloride market. Allergies such as eczema, food allergies, and allergic rhinitis are becoming more common, increasing the demand for effective treatments like cetirizine hydrochloride. For instance, according to the CDC’s National Center for Health Statistics, more than 1 in 4 American children and over 1 in 3 American adults reported having a food allergy, eczema, or seasonal allergy in 2021[3].

Advancements in Healthcare Infrastructure

The expansion and improvement of healthcare infrastructure, particularly in regions like North America, Europe, and the Asia Pacific, are contributing to the market growth. These regions have robust healthcare systems, increasing awareness about allergy management, and a strong emphasis on innovation, which drives the demand for cetirizine hydrochloride[1].

Generic Versions and Accessibility

The introduction of generic versions of cetirizine hydrochloride has increased competition in the market, leading to lower prices and greater accessibility for people from a broader range of socioeconomic backgrounds. This has further boosted the market's growth potential[3].

Market Segmentation

By Dosage Form

The market is segmented by dosage form into tablets, syrup, and solution. Each form caters to different patient needs and preferences, ensuring a wide range of treatment options[1].

By Age Group

Cetirizine hydrochloride is used across various age groups, including adults and pediatric patients. This broad applicability helps in maintaining a steady demand across different demographics[1].

By Application

The drug is used for treating several allergic conditions, including allergic rhinitis, allergic conjunctivitis, eczema, and others. The versatility of cetirizine hydrochloride in addressing multiple allergy types contributes to its market growth[1].

By Distribution Channel

The market is segmented by distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies. The increasing availability of cetirizine hydrochloride through these channels enhances its accessibility and convenience for patients[1].

Geographical Insights

North America

North America is a prominent market for cetirizine hydrochloride, driven by a high prevalence of allergic conditions, robust healthcare infrastructure, and a strong emphasis on innovation. The region's mature pharmaceutical industry and increasing awareness about allergy management contribute significantly to market growth[1].

Europe

Europe's market is characterized by stringent regulatory standards, sophisticated healthcare systems, and a growing focus on personalized medicine. Increasing investment in research and development makes Europe a key market for pharmaceutical innovations, including cetirizine hydrochloride[1].

Asia Pacific

The Asia Pacific region is experiencing rapid market expansion due to a large population base, rising disposable incomes, and increasing healthcare expenditure. Growing urbanization, changing lifestyles, and a surge in allergic disorders drive the demand for cetirizine hydrochloride in countries like China, India, Japan, and South Korea[1].

Middle East and Africa

The Middle East and Africa region experiences steady growth, propelled by improving healthcare infrastructure, rising awareness about allergy management, and expanding access to pharmaceutical products. Despite challenges related to regulatory frameworks and economic stability, the region presents untapped potential for market expansion[1].

Latin America

Latin America represents a dynamic market, characterized by a diverse population, increasing healthcare expenditure, and a growing prevalence of allergic conditions. Market growth in this region is driven by factors such as urbanization, changing lifestyles, and expanding access to healthcare services[1].

Financial Trajectory

Revenue and Growth Projections

The global cetirizine hydrochloride market is expected 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 projected to reach USD 8.0 billion, growing at a CAGR of 2.6% from 2024 to 2034[1][3].

Budget Impact and Cost Analysis

In the context of emergency department settings, the adoption of intravenous cetirizine hydrochloride has shown a positive budget impact. For instance, in one scenario, the adoption of IV cetirizine resulted in a positive net budget impact of $27,876, primarily due to reduced operational costs and increased revenue from treating additional patients[2].

Challenges and Opportunities

Threat of New Medications

The development of new medications could potentially slow the growth rate of the cetirizine hydrochloride market. However, the established safety profile and effectiveness of cetirizine hydrochloride are likely to maintain its market position[3].

Regulatory Frameworks

Stringent regulatory standards, particularly in regions like Europe, can pose challenges for market growth. However, compliance with these regulations can also ensure the quality and safety of the drug, maintaining consumer trust[1].

Emerging Markets

Regions like the Asia Pacific, Latin America, and the Middle East and Africa present significant opportunities for market expansion. Increasing healthcare expenditure, growing awareness about allergy management, and improving healthcare infrastructure in these regions are expected to drive future growth[1][3].

Key Takeaways

• The global cetirizine hydrochloride market is valued at USD 6.213 billion in 2023 and is expected to grow to USD 7.236 billion by 2030.
• 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 cetirizine hydrochloride in emergency department settings has shown a positive budget impact.

FAQs

What is the current market size of cetirizine hydrochloride?

The global cetirizine hydrochloride market was valued at approximately USD 6.213 billion in 2023[1].

What is the projected growth rate of the cetirizine hydrochloride market?

The market is expected to grow at a CAGR of 2.2% from 2023 to 2030 and at a CAGR of 2.6% from 2024 to 2034[1][3].

Which regions are driving the growth of the cetirizine hydrochloride 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[1].

What are the main drivers of the cetirizine hydrochloride market?

The main drivers include the increasing prevalence of allergic disorders, advancements in healthcare infrastructure, and the availability of generic versions of the drug[1][3].

How does the adoption of intravenous cetirizine hydrochloride impact the budget in emergency department settings?

The adoption of IV cetirizine has shown a positive budget impact, primarily due to reduced operational costs and increased revenue from treating additional patients[2].

Sources

1. Global Cetirizine Hydrochloride Market Growth, Share, Size, Trends and Forecast (2024 - 2030). Reanin.
2. Budget Impact of Intravenous Cetirizine Hydrochloride for the Treatment of Acute Urticaria in the Emergency Department Setting. AHDB Online.
3. Cetirizine Hydrochloride Market Size, Trends and Forecast to 2034. Prophecy Market Insights.
4. Cetirizine Hydrochloride Market Key Players, Sales, Demand, Dynamic Forces and Forecast 2029. BioSpace.