Cetirizine hydrochloride - Generic Drug Details

What are the generic sources for cetirizine hydrochloride and what is the scope of freedom to operate?

Cetirizine hydrochloride is the generic ingredient in sixteen branded drugs marketed by Apotex, Aurobindo Pharma Ltd, Bionpharma, Catalent, Onesource Specialty, 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, Kenvue Brands, J And J Consumer Inc, Sun Pharm Inds Inc, Jubilant Generics, Novel Labs Inc, Sandoz, Sun Pharm, Regcon Holdings, Aiping Pharm Inc, Amneal Pharms Ny, Apotex Inc, Cipla Ltd, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Granules, Heritage Pharma, 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 thirty patent family members in eight countries.

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

Summary for cetirizine hydrochloride

International Patents:	30
US Patents:	9
Tradenames:	16
Applicants:	53
NDAs:	78
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	159
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	94
Patent Applications:	6,288
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cetirizine hydrochloride
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
Pengfei Qiu	NA
Shandong New Time Pharmaceutical Co., LTD	PHASE3
Emory University	Phase 3

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
Aurobindo Pharma Ltd	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212409-001	Mar 8, 2023		DISCN	No	No
Apozeal Pharms	CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	078870-001	Apr 27, 2009	AA	RX	No	No
Amneal Pharms	CETIRIZINE HYDROCHLORIDE	cetirizine hydrochloride	SOLUTION;ORAL	090766-001	Oct 7, 2009	AA	RX	No	No
Quagen	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	212266-001	May 16, 2019		OTC	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
Kenvue Brands	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007	6,455,533
Kenvue Brands	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007	6,455,533
Kenvue Brands	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007	6,455,533

International Patents for cetirizine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2018141022	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)
Japan	2020117544	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)
Japan	2012520882
European Patent Office	2408453

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

Market Dynamics and Financial Trajectory for Cetirizine Hydrochloride

Last updated: December 30, 2025

Executive Summary

Cetirizine Hydrochloride, a second-generation antihistamine widely prescribed to manage allergic rhinitis and chronic urticaria, has experienced sustained growth driven by increasing allergy prevalence, expanding global healthcare accessibility, and evolving treatment paradigms. The market landscape is characterized by robust demand, competitive genericization, regulatory dynamics, and the potential for innovative formulations. This report analyzes current market drivers, competitive forces, regulatory influences, and future economic expectations, offering strategic insights for stakeholders.

---

Introduction: Overview of Cetirizine Hydrochloride

Chemical Profile and Therapeutic Use
Cetirizine Hydrochloride (C21H25ClN2O3·HCl) is a selective peripheral H1-antihistamine. Licensed initially in the 1980s, it offers rapid onset, minimal sedation, and high patient compliance. The drug’s primary indications include:

• Allergic rhinitis
• Chronic idiopathic urticaria
• Other allergic conditions

Market Penetration
As of 2023, cetirizine remains a top-selling antihistamine globally, both in prescription and OTC segments.

---

Market Drivers

Rising Prevalence of Allergic Conditions

Indicator	Data	Source
Global allergy prevalence	Estimated at 30-40%	WHO[1]
Rising allergic rhinitis cases (2015-2023 CAGR)	4.2%	GlobalData[2]

Increased environmental pollution, urbanization, and climate change contribute to this rise, boosting cetirizine demand.

---

Expanding Global Healthcare Access

Region	Growth in Healthcare Spending (2020-2027 CAGR)	Key Markets
North America	3.8%	US, Canada
Europe	2.9%	Germany, France, UK
Asia-Pacific	6.2%	China, India, ASEAN

Improved healthcare infrastructure enlarges patient access leading to higher prescription volumes.

---

Shift Towards OTC Availability

• Regulatory Approvals: Many countries have transitioned cetirizine from prescription-only to OTC, expanding consumer access.
• Market Impact: OTC sales now constitute approximately 60-65% of global cetirizine revenues[3].

Growth of E-Commerce & Retail Pharmacies

Digital sales channels increased by over 15% annually, facilitating consumer choice and boosting ongoing sales.

---

Market Challenges

Generic Competition & Price Erosion

Major Companies	Market Share (%)	Notes
Teva Pharmaceuticals	20%	Leading generic producer
Mylan/Namem	15%	Significant market presence
Sun Pharmaceutical	10%	Increasing market share

Pricing pressures due to generic proliferation lead to margin compression, especially in mature markets.

Regulatory Variability

Region	Key Policies	Impact
US	FDA OTC switch	Increased accessibility
EU	Variation in OTC regulation	Market fragmentation

Regulatory hurdles can delay or restrict launch of new formulations.

Market Saturation & Maturation

In developed markets, growth stabilizes as penetration nears maximum levels, necessitating innovation for future expansion.

---

Financial Trajectory: Revenue and Market Forecasts

Historical Revenue Trends

Year	Global Revenue (USD Billion)	CAGR (2018-2022)	Comments
2018	1.2	—	Steady growth
2020	1.4	12.5%	Increased OTC sales
2022	1.65	13.2%	Pandemic influence led to higher self-medication

Projected Future Market Size

Year	Predicted Revenue (USD Billion)	CAGR (2023-2028)	Notes
2023	1.75	—	Estimated
2028	2.3	7.1%	Driven by emerging markets

Growth electronics, globalization, and demographic shifts underpin these projections.

---

Market Segmentation

Segment	Share (%)	Drivers	Key Players
Prescription	45%	Severe allergies, physician oversight	Pfizer, Novartis
OTC	55%	Self-medication, OTC availability	Sun Pharma, Mylan

Regional Revenue Breakdown (2022)

Region	Revenue (USD Billion)	Percentage of Global Market	Growth Drivers
North America	0.65	39%	OTC dominance, high allergy prevalence
Europe	0.45	27%	Prescription availability, mature market
Asia-Pacific	0.30	18%	Growing healthcare access, urbanization
Rest of World	0.25	16%	Emerging markets, expanding OTC

---

Competitive Landscape and Innovation

Key Players

• Teva Pharmaceuticals: Leading generic cetirizine producer, with global market share.
• Sun Pharmaceutical: Significant OTC portfolio.
• Mylan: Extensive distribution channels.
• Pfizer & Novartis: Focus on branded formulations and formulations with additional benefits.

Innovation Opportunities

• Novel Formulations: Fast-dissolving tablets, liquid gels.
• Combination Therapy: CETIRIZINE + Decongestants or corticosteroids.
• Improved Safety Profile: Non-sedating variants with extended release.

Patent and Regulatory Status

• Most patents expired by 2010, leading to widespread genericization.
• Recent regulatory decisions favor OTC switches in numerous jurisdictions, enabling market expansion.

---

Regulatory and Policy Influences

Country/Region	Key Regulation	Effect on Market	References
US	FDA OTC switch	Facilitates widespread retail access	[4]
EU	Varies; some countries restrict OTC	Fragmented growth	[5]
India	Over-the-counter availability	Surge in sales	[6]

Policy Trends

• Emphasis on OTC access for minor ailments.
• Home medication, particularly post-pandemic, increased due to telehealth.

---

Comparative Analysis: Cetirizine vs Alternatives

Metric	Cetirizine	Loratadine	Fexofenadine
Onset of Action	1 hour	1-3 hours	1-2 hours
Sedation Risk	Very low	Low	Very low
Cost (USD)	$0.10–$0.50/tablet	$0.15–$0.60/tablet	$0.20–$0.70/tablet
Market Penetration	Highest among second-gen antihistamines	Slightly lower	Similar

---

Future Outlook: Opportunities and Risks

Opportunities

• Emerging Markets: Asia-Pacific, Latin America, with CAGR >6.0%.
• Formulation Innovation: Orally disintegrating tablets, patches.
• Digital Health: Integration with telemedicine platforms.

Risks

• Pricing Pressures: Margins under threat from increasing generics.
• Regulatory Barriers: Sudden policy shifts could restrict access.
• Market Saturation: Need for R&D-driven product differentiation.

---

Key Takeaways

Insight	Actionable Strategy
Growing allergy prevalence fuels drug demand	Invest in market presence within emerging markets
OTC proliferation enhances sales volumes	Develop consumer-friendly formulations and educate pharmacists
Patent expirations have increased generic competition	Focus on cost-effective manufacturing and distribution
Innovation remains critical	Explore combination therapies and novel delivery systems
Regulatory landscape varies	Monitor policy trends to facilitate timely market access

---

FAQs

Q1. What is the primary growth driver for cetirizine in the next five years?
Increasing global allergy prevalence and expanding OTC availability are anticipated to sustain growth, especially in emerging markets.

Q2. How does the generic competition impact cetirizine’s profitability?
Widespread patent expirations have driven prices down, squeezing margins but expanding market volume. Effective cost management remains crucial.

Q3. What regulatory changes could influence cetirizine markets?
OTC switches, reclassification policies, and new safety regulations could either open new channels or impose restrictions.

Q4. Are there innovative formulations in development for cetirizine?
Yes, including orodispersible tablets, extended-release formulations, and combination therapies to improve efficacy and compliance.

Q5. Which regions present the highest growth opportunities for cetirizine?
Asia-Pacific and Latin America are projected to exhibit the highest CAGR, driven by urbanization and increased healthcare access.

---

References

[1] World Health Organization. "Allergy Facts." 2022.
[2] GlobalData. "Allergy Market Trends," 2023.
[3] IMS Health Reports. "OTC Drugs Market Share," 2022.
[4] US FDA. "OTC Monographs," 2021.
[5] European Medicines Agency. "Dossier on Histamine Antagonists," 2022.
[6] Indian Ministry of Health. "OTC Drug Policies," 2023.

---

This comprehensive analysis offers a strategic perspective on the current and future market landscape for Cetirizine Hydrochloride. Stakeholders should capitalize on emerging opportunities, mitigate competitive pressures, and stay abreast of regulatory developments to sustain growth and profitability.