CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details

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

Cetirizine hydrochloride; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Pld Acquisitions, Ppi-dac, Sun Pharm Inds Ltd, Unichem, and Kenvue Brands, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-four suppliers are listed for this compound.

Summary for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	24
Clinical Trials:	4
DailyMed Link:	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

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

Sponsor	Phase
Fraunhofer-Institute of Toxicology and Experimental Medicine	N/A
GlaxoSmithKline	N/A
Sandoz	Phase 1

See all CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

Pharmacology for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

Paragraph IV (Patent) Challenges for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYRTEC-D 12 HOUR	Extended-release Tablets	cetirizine hydrochloride; pseudoephedrine hydrochloride	5 mg/120 mg	021150	1	2004-06-02

US Patents and Regulatory Information for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE 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
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007		OTC	Yes	Yes
Pld Acquisitions	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077991-001	Mar 5, 2008		OTC	No	No
Sun Pharm Inds Ltd	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090922-001	Sep 28, 2012		OTC	No	No
Unichem	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210507-001	Sep 10, 2024		DISCN	No	No

Expired US Patents for CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007

Market Dynamics and Financial Trajectory for Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape for antihistamines and nasal decongestants remains robust, notably with cetirizine hydrochloride and pseudoephedrine hydrochloride holding prominent positions. These compounds are ubiquitous in allergy relief and cold symptom management, constituting a significant segment within respiratory and allergy pharmaceuticals. Understanding their market dynamics and financial trends is critical for stakeholders—including manufacturers, investors, and healthcare policymakers—aiming to navigate this complex sector efficiently.

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Market Overview of Cetirizine Hydrochloride

Product Profile and Therapeutic Use

Cetirizine hydrochloride is a second-generation antihistamine widely prescribed for allergic rhinitis, chronic urticaria, and perennial allergic conjunctivitis. Its favorable safety profile, minimal sedative effects, and once-daily dosing have cemented its dominance among OTC and prescription antihistamines. Major products include branded formulations (e.g., Zyrtec by UCB and Hydroxyzine by pharmaceutical generics).

Global Market Dynamics

The cetirizine market is driven by increasing prevalence of allergic conditions worldwide. The rising recognition of allergy-related afflictions, coupled with the expanding aging population susceptible to such disorders, fuels demand. Moreover, the shift toward OTC availability in regions like North America and Europe has amplified accessibility, bolstering sales.

Key growth drivers include:

• Epidemiological trends: A surge in allergic rhinitis prevalence, especially among urban populations exposed to pollution.
• Rising awareness: Improved diagnosis and health literacy encourage patients to seek relief options.
• Product innovation: Development of formulations with enhanced bioavailability or combination therapies.

Market Competition and Regulatory Factors

The landscape is characterized by a high number of generic manufacturers post patent expiry, intensifying price competition and squeezing margins. Stringent regulatory standards impose quality assurance norms, but also present entry barriers, especially in stringent markets like the U.S. (FDA) and EU (EMA). Patent cliffs or brand saturation may impact revenue streams, necessitating diversification into biosimilars or novel pharmacological formulations.

Financial Performance and Outlook

The global cetirizine market value was estimated at approximately USD 1.5 billion in 2022, with a compound annual growth rate (CAGR) projected at 4-5% over the next five years (1). Key markets such as North America and Europe will continue to dominate, driven by high per capita healthcare expenditure and well-established OTC channels.

Emerging markets—like Asia-Pacific—are expected to contribute substantially to growth due to increasing urbanization, income growth, and expanding healthcare infrastructure. The proliferation of online pharmacies also amplifies accessibility, driving further sales.

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Market Dynamics of Pseudoephedrine Hydrochloride

Product Profile and Therapeutic Use

Pseudoephedrine hydrochloride is a powerful nasal decongestant primarily used to relieve sinus and nasal congestion associated with allergic rhinitis, colds, and sinusitis. It acts on adrenergic receptors to constrict blood vessels, reducing swelling.

Regulatory and Supply Chain Considerations

Pseudoephedrine’s widespread use in methamphetamine synthesis has resulted in significant regulatory controls worldwide, notably:

• US DEA Regulations: Pseudoephedrine is classified as a scheduled listed chemical, with purchase limits and record-keeping mandates.
• International Controls: Similar restrictions exist in the EU, Australia, and other jurisdictions.

These regulations impact the supply chain, increase manufacturing costs, and influence market supply dynamics. Consequently, pharmaceutical companies often face hurdles in sourcing raw materials, which can lead to increased prices and potential shortages.

Market Trends and Influencers

Demand remains stable, driven by the common cold and allergy segments. However, the growth trajectory is constrained by regulatory controls and the rise of alternative therapies, such as intranasal corticosteroids and combination antihistamines that reduce reliance on pseudoephedrine.

The global pseudoephedrine market was valued around USD 200 million in 2022, with a CAGR of approximately 2-3% (2). The slower growth rate reflects regulatory constraints more than medical need.

Impact of Regulatory Restrictions

Government controls have a dual effect:

• Supply Limitation: Tightened controls restrict supply, affecting availability and pricing.
• Market Consolidation: Smaller manufacturers struggle with regulatory compliance, favoring large, compliant players.

These dynamics pushed some manufacturers to develop pseudoephedrine-free formulations or employ alternative decongestion agents, such as phenylephrine, which faces different regulatory challenges.

Financial Trajectory

Pricing volatility is common, influenced heavily by governmental policies. As a result, profit margins are compressed, with revenues primarily driven by existing production capacities rather than new market expansion. The market's future hinges on regulatory environments and consumer preferences shifting towards non-scheduled alternatives.

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Comparative Analysis and Market Interdependencies

While cetirizine and pseudoephedrine serve different therapeutic roles, their combined use is common in cold and allergy formulations, creating synergies and competitive challenges. For example, combination products or formulations that include both compounds are prevalent, especially in OTC cold remedies.

Market interplay is influenced by:

• Regulatory divergence: While cetirizine faces minimal restrictions, pseudoephedrine’s market is heavily regulated.
• Consumer shifts: Growing preference for natural or non-pharmacologic remedies may impact future demand.
• Innovation and reformulation: Developers are exploring non-controlled decongestants to bypass regulatory constraints, affecting pseudoephedrine's market share.

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Future Outlook and Growth Opportunities

For Cetirizine Hydrochloride

• Regional Expansion: Entering emerging markets, leveraging OTC channels.
• Product Differentiation: Developing multi-ingredient formulations to address broader allergy symptoms.
• Biosimilars and Generics: Capitalizing on patent expiries to gain market share.

For Pseudoephedrine Hydrochloride

• Alternative Therapies: Investment in non-regulated decongestants with comparable efficacy.
• Supply Chain Innovations: Enhancing manufacturing efficiency and regulatory compliance.
• Regulatory Navigation: Advocacy and compliance strategies to stabilize supply and pricing.

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Key Takeaways

• The cetirizine hydrochloride market exhibits steady growth driven by allergy prevalence and OTC availability, with a strong export and emerging market presence.
• Pseudoephedrine hydrochloride faces regulatory scrutiny that constrains supply, influencing pricing and availability, with future growth linked to alternative formulations.
• The convergence of regulatory, technological, and consumer trends will substantially shape market trajectories.
• Diversification and innovation—particularly in non-controlled decongestant formulations—are critical for leveraging growth.
• Strategic positioning in regional markets and investment in formulation development remain vital for stakeholder success.

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FAQs

Q1: How do regulatory restrictions impact the pseudoephedrine market?
A1: Pseudoephedrine's association with methamphetamine synthesis leads to strict regulations, including purchase limits and record-keeping, which restrict raw material supply, increase costs, and limit market growth.

Q2: What are the key growth drivers for cetirizine hydrochloride?
A2: Increasing prevalence of allergic conditions, rising awareness, OTC availability, and product innovation are primary drivers.

Q3: Are there alternative medications to pseudoephedrine?
A3: Yes, intranasal corticosteroids and phenylephrine serve as alternatives, though regulatory and efficacy considerations influence their adoption.

Q4: What is the impact of patent expiries on cetirizine?
A4: Patent expiries enable generic manufacturers to enter the market, increasing competition, reducing prices, and expanding distribution channels.

Q5: How are emerging markets influencing these drug markets?
A5: Growth in these regions, driven by urbanization and healthcare infrastructure development, offers substantial opportunities, especially as OTC and affordable formulations become accessible.

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References:

1. Market Research Future, "Global Antihistamines Market Analysis," 2022.
2. Reports and market estimates from Adroit Market Research, 2022.