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 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-seven 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:	157
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
Kenvue Brands	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	SOLUTION;ORAL	022155-002	Nov 16, 2007		OTC	Yes	Yes
Taro	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	SOLUTION;ORAL	090182-001	Apr 22, 2008		OTC	No	No
Taro	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	cetirizine hydrochloride	TABLET;ORAL	078072-004	Jul 22, 2009		DISCN	No	No
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	077498-001	Dec 27, 2007		OTC	No	No
Perrigo R And D	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	078336-001	Dec 27, 2007		OTC	No	No
Orbion Pharms	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	TABLET;ORAL	078862-001	Feb 19, 2009		OTC	No	No
Harrow Eye	ZERVIATE	cetirizine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208694-001	May 30, 2017		RX	Yes	Yes					Y

Expired US Patents for CETIRIZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-006	Nov 16, 2007
J And J Consumer Inc	ZYRTEC	cetirizine hydrochloride	SOLUTION;ORAL	020346-001	Sep 27, 1996
Kenvue Brands	CHILDREN'S ZYRTEC HIVES RELIEF	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-005	Nov 16, 2007
Kenvue Brands	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-004	Nov 16, 2007
Kenvue Brands	CHILDREN'S ZYRTEC ALLERGY	cetirizine hydrochloride	TABLET, CHEWABLE;ORAL	021621-003	Nov 16, 2007

International Patents for CETIRIZINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2010266103	Non-sedating antihistamine injection formulations and methods of use thereof
Japan	2016190879	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)
European Patent Office	3943069	FORMULATIONS OPHTALMIQUES DE CETIRIZINE ET PROCEDES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)
European Patent Office	2547340	FORMULATIONS OPHTHALMIQUES DE CÉTIRIZINE ET LEURS MÉTHODES D'UTILISATION (OPHTHALMIC FORMULATIONS OF CETIRIZINE AND METHODS OF USE)
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)
Japan	6449202

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: July 27, 2025

Introduction

Cetirizine hydrochloride, a second-generation antihistamine, stands as a cornerstone in allergy and respiratory drug portfolios worldwide. Recognized for its efficacy in treating allergic rhinitis, chronic idiopathic urticaria, and other allergic conditions, cetirizine's market presence continues to evolve amid shifting healthcare landscapes, regulatory frameworks, and consumer preferences. This analysis delineates the core market dynamics shaping cetirizine hydrochloride’s trajectory and projects its financial outlook over the coming years.

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Market Landscape and Competitive Environment

The global antihistamines market totaled approximately USD 4.2 billion in 2022, with cetirizine hydrochloride constituting a significant share due to its widespread acceptance, clinical efficacy, and favorable safety profile. The competitive landscape includes both branded and generic manufacturers, with key players such as UCB, Mylan, Sandoz, and local generic producers heavily influencing market consolidation and innovation dynamics.

The patent expiry of several first-generation antihistamines has accelerated the shift towards second-generation compounds like cetirizine. Its non-sedating profile and once-daily dosing have driven consumer preference, further cementing its market dominance.

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Market Drivers

Rising Prevalence of Allergic Conditions

Increasing global prevalence of allergic rhinitis, estimated to affect up to 30% of the population in developed nations, underpins sustained demand for antihistamines, including cetirizine. Urbanization, pollution, and climate change have contributed to rising allergen exposure, propelling the allergy treatment market.

Aging Population

The growth of geriatric populations with chronic allergic conditions sustains market expansion. Older adults often require long-term management of allergies, favoring medications with proven safety profiles like cetirizine.

Regulatory and Prescription Trends

Regulatory bodies favor second-generation antihistamines owing to their safety and minimal sedative effects. As a result, prescribing patterns favor cetirizine, reinforcing its market position.

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Market Restraints and Challenges

Pricing and Generic Competition

The expiration of patents has led to a surge in generic cetirizine products, exerting downward pressure on prices and profit margins. This proliferation challenges branded formulations' exclusivity and profitability.

Market Saturation and Competition from Alternatives

Newer antihistamines and combination therapies are entering the market, offering broader symptom relief or improved formulations. Additionally, oral allergen immunotherapies provide alternative long-term solutions, potentially cannibalizing cetirizine’s market share.

Regulatory Barriers in Emerging Markets

Varying regulatory standards and approval processes pose challenges for market entry and expansion, especially in developing economies.

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Emerging Market Opportunities

Emerging markets, notably in Asia-Pacific and Latin America, exhibit rapid growth due to increasing allergy awareness, expanding healthcare infrastructure, and evolving prescription practices. Local manufacturers, often offering lower-priced generic cetirizine, dominate these regions, though global players continue to gain market share through strategic partnerships and localized marketing.

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Financial Trajectory and Revenue Projections

Historical Perspective

From 2015 to 2022, global cetirizine hydrochloride revenues grew at a compound annual growth rate (CAGR) of approximately 4-6%. This steady trajectory reflects robust demand, driven primarily by generics, with branded formulations accounting for a minor market share primarily in specific regions.

Short-Term Outlook (2023–2025)

The coming years are characterized by price erosion due to generic competition but balanced by increased volume sales facilitated by expanding allergy prevalence. Strategic alliances, market penetration, and differentiated formulations may mitigate margin pressures.

Projected Revenue Growth:
Analysts estimate a tempered CAGR of 2-3% during this period, with total revenues reaching approximately USD 5 billion globally by 2025.

Mid to Long-Term Outlook (2026–2030)

Innovation in drug delivery, combination therapies, and personalized medicine could influence cetirizine’s standing. While market saturation is probable in mature regions, emerging markets could drive renewed growth.

Potential Market Development:
With increased healthcare awareness and affordability, revenues may grow at a CAGR of 3-4%, potentially surpassing USD 6 billion by 2030 if new formulations or indications emerge.

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Strategic Factors Influencing Financial Performance

• Patent Cliff Management: Companies heavily reliant on branded formulations may face earnings erosion post-patent expiration unless they diversify through product pipelines or formulations.
• Manufacturing and Supply Chain Optimization: Cost reductions and capacity expansion in emerging markets could bolster margins.
• Regulatory Approvals: Fast-track approvals or new indications (e.g., for pediatric use) could stimulate revenues.
• Market Penetration Strategies: Local partnerships and price strategies in developing countries remain pivotal.

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Regulatory and Legal Considerations

Regulatory agencies like the FDA, EMA, and others have increasingly emphasized safety and efficacy data, especially in regards to generics. Thorough regulatory compliance and robust pharmacovigilance are essential for sustained market access and financial stability.

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Conclusion

Cetirizine hydrochloride’s market remains resilient amidst competitive pressures and pricing challenges stemming from patent expiries. Its continued demand, driven by allergy prevalence and favorable safety profile, supports a cautiously optimistic financial outlook. Companies that innovate, improve supply efficiencies, and strategically target emerging markets will likely sustain growth trajectories in the evolving antihistamines landscape.

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Key Takeaways

• Steady Demand: Rising allergy prevalence ensures persistent demand for cetirizine globally.
• Pricing Pressure: Patent expirations and generic entry necessitate strategic pricing and differentiation.
• Emerging Markets: High growth potential exists in Asia-Pacific and Latin America, driven by expanding healthcare infrastructure.
• Innovation Needs: Development of new formulations or combination therapies can offset market saturation.
• Regulatory Vigilance: Compliance with evolving standards secures ongoing market access and financial performance.

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FAQs

1. How does patent expiry impact cetirizine hydrochloride revenues?
Patent expiry leads to the proliferation of generic versions, significantly reducing prices and profit margins for branded formulations, thereby impacting overall revenues unless offset by increased volume sales or new product innovations.

2. What new developments could influence cetirizine’s market position?
Innovations such as extended-release formulations, combination therapies with other antihistamines or corticosteroids, and pediatric or long-acting versions could expand its usage and market share.

3. Which geographic regions offer the most growth opportunities for cetirizine?
Growing markets include Asia-Pacific and Latin America due to demographic shifts, increasing allergy awareness, and expanding healthcare infrastructure, offering sizable opportunities for market penetration.

4. How does competition from newer antihistamines affect cetirizine’s market?
While newer agents may offer improved symptom control or additional benefits, cetirizine's established safety profile and low cost sustain its relevance, especially in markets emphasizing affordability.

5. What are the primary risks to cetirizine’s future growth?
Key risks include aggressive generic price competition, regulatory hurdles, emergence of alternative allergy therapies, and shifting prescriber preferences towards combination or novel treatments.

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References

[1] Market Research Future, “Antihistamines Market,” 2022.
[2] Mordor Intelligence, “Global Cetirizine Market,” 2022.
[3] WHO, “Prevalence of Allergic Rhinitis,” 2021.
[4] European Medicines Agency, “Regulatory Updates on Antihistamines,” 2022.
[5] IQVIA, “Pharmaceutical Market Trends,” 2022.