ZYRTEC-D 12 HOUR Drug Patent Profile

When do Zyrtec-d 12 Hour patents expire, and when can generic versions of Zyrtec-d 12 Hour launch?

Zyrtec-d 12 Hour is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in ZYRTEC-D 12 HOUR is cetirizine hydrochloride; pseudoephedrine hydrochloride. There are thirty-nine drug master file entries for this compound. Twenty-four 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-d 12 Hour

A generic version of ZYRTEC-D 12 HOUR was approved as cetirizine hydrochloride; pseudoephedrine hydrochloride by IVAX SUB TEVA PHARMS on February 25^th, 2008.

Summary for ZYRTEC-D 12 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	30
Patent Applications:	12
DailyMed Link:	ZYRTEC-D 12 HOUR at DailyMed

Recent Clinical Trials for ZYRTEC-D 12 HOUR

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-D 12 HOUR clinical trials

Pharmacology for ZYRTEC-D 12 HOUR

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

Paragraph IV (Patent) Challenges for ZYRTEC-D 12 HOUR

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 ZYRTEC-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	ZYRTEC-D 12 HOUR	cetirizine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021150-002	Nov 9, 2007		OTC	Yes	Yes

Expired US Patents for ZYRTEC-D 12 HOUR

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

International Patents for ZYRTEC-D 12 HOUR

See the table below for patents covering ZYRTEC-D 12 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	2311940	Pharmaceutical compositions for the treatment of rhinitis
Australia	723364
New Zealand	530289	Pharmaceutical composition comprising cetirizine and pseudoephedrine that contains less than 5% or no alkalinising agent
South Korea	100926410
Japan	2007176958	TABLET COMPRISING CETIRIZINE AND PSEUDOEPHEDRINE

Supplementary Protection Certificates for ZYRTEC-D 12 HOUR

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

Market Dynamics and Financial Trajectory for ZYRTEC-D 12 HOUR

Last updated: July 28, 2025

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Introduction

ZYRTEC-D 12 HOUR, a prominent over-the-counter (OTC) medication combining cetirizine with pseudoephedrine, targets seasonal allergic rhinitis and perennial allergic symptoms. Its unique formulation caters to consumers seeking 12-hour symptom relief, positioning it within a competitive market landscape characterized by evolving regulatory, consumer, and healthcare dynamics. Understanding its market trajectory involves analyzing product attributes, competitive forces, regulatory challenges, and macroeconomic factors shaping its trajectory.

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Product Profile and Differentiation

ZYRTEC-D 12 HOUR’s formulation offers sustained allergy symptom relief by combining cetirizine, an antihistamine, with pseudoephedrine, a decongestant. This dual-action positions the product distinctly among allergy medications, appealing to consumers seeking convenience and prolonged efficacy. The extended 12-hour duration distinguishes it from shorter-acting formulations such as loratadine or chlorpheniramine-based products.

Its OTC status in many markets, including the U.S.,Leverages direct consumer access, fueling sales volume. However, its reliance on pseudoephedrine as an active ingredient involves regulatory oversight due to pseudoephedrine’s potential for misuse, impacting inventory management and pharmacy stocking.

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Market Size and Segmentation

The allergy therapeutics market globally commands an estimated valuation of over USD 13 billion in 2023, with the OTC segment accounting for approximately 65% of total sales [1]. ZYRTEC (cetirizine), branded by Johnson & Johnson (J&J), holds a significant market share, particularly in North America and parts of Europe.

Segmentation analysis reveals that urban, middle-income consumers with seasonal allergy experiences constitute the primary consumer base. Additionally, the aging demographic increasingly seeks long-lasting relief options, further expanding the market size for 12-hour formulations.

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Competitive Landscape

The competitive environment encompasses both branded and generic antihistamine-decongestant products:

• Branded equivalents: Allegra-D, Claritin-D, and Nasalcrom, all offering variations of antihistamine combinations, vie for share based on efficacy perceptions and marketing strength.

• Generics: A proliferation of authorized generics significantly pressures pricing and profit margins.

• Emerging entrants: Novel formulations, such as intranasal sprays and non-drowsy combinations, challenge traditional oral therapies, especially as consumer preferences shift towards convenience and fewer side effects.

Notably, the shift towards sustained-release formulations and non-sedating alternatives influences market shares and demand patterns.

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Regulatory and Supply Chain Dynamics

Pseudoephedrine’s classification as a controlled substance in jurisdictions like the U.S. introduces regulatory challenges, including restrictions on purchase quantity, storage, and shipping. The Combat Methamphetamine Epidemic Act (CMEA) of 2005 limits sales to behind-the-counter or prescription, compelling manufacturers to adapt supply chain logistics accordingly.

Furthermore, regulatory agencies scrutinize marketing claims and formulation safety, prompting J&J and competitors to invest in clinical data and educational campaigns, impacting R&D and marketing expenses.

Supply chain disruptions, such as those observed during the COVID-19 pandemic, have temporarily constrained raw material availability, thereby influencing production and distribution timelines.

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Pricing and Reimbursement Trends

While OTC drugs traditionally operate outside formal reimbursement systems, the rising consumer health expenditure and insurance coverage for OTC products in certain markets influence pricing strategies. J&J leverages brand recognition and perceived efficacy to command premium pricing, although generic proliferation exerts downward pressure.

Pricing elasticity remains moderate; consumers gravitate toward value options, especially amid economic uncertainty. Promotional activities and bundling strategies are prevalent to retain consumer loyalty.

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Market Growth Drivers

1. Increasing prevalence of allergic conditions: Rising urbanization and environmental pollution exacerbate allergy incidences, expanding potential consumer bases [2].

2. Consumer awareness: Greater health literacy and proactive management of allergy symptoms foster demand for sustained-release OTC options.

3. Product innovation: Advancements in formulation technology and combination therapies enhance product efficacy and convenience, bolstering market attractiveness.

4. Regulatory support: Relaxation of OTC classification criteria in some regions encourages wider access, facilitating growth.

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Market Risks and Challenges

• Regulatory hurdles: Stricter controls on pseudoephedrine may curtail sales or lead to formulation alterations.

• Generic competition: Price-sensitive consumers favor generics, compressing margins.

• Safety concerns: Reports of pseudoephedrine misuse or side effects could lead to regulatory restrictions or negative consumer perceptions.

• Market saturation: High adoption levels in mature markets limit new growth opportunities without innovation.

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Financial Trajectory and Forecast

The revenue outlook for ZYRTEC-D 12 HOUR exhibits a moderate growth trajectory driven by:

• Market penetration: Continued expansion in emerging markets with developing OTC markets.

• Product line extensions: Introduction of new formulations or combination variants could diversify offerings.

• Brand loyalty: J&J’s strong marketing and consumer trust bolster repeat sales.

Analyst projections forecast a CAGR of approximately 3-4% in global OTC allergy medication sales over the next five years, with ZYRTEC-D 12 HOUR expected to maintain a significant share. However, profit margins may face contraction due to escalating generic competition and regulatory compliance costs.

In North America, sales are anticipated to stabilize or slightly decline as market saturation occurs, whereas emerging markets such as Asia-Pacific may experience higher growth rates, driven by expanding middle-class populations and increasing allergy awareness.

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Strategic Implications

To sustain growth, stakeholders should consider:

• Investing in formulation innovation to enhance safety and efficacy.
• Strengthening supply chain resilience to mitigate disruptions.
• Navigating regulatory landscapes through proactive compliance strategies.
• Employing targeted marketing to educate consumers and differentiate the brand.
• Exploring partnerships for market expansion, particularly in high-growth regions.

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Key Takeaways

• ZYRTEC-D 12 HOUR’s unique 12-hour formulation positions it favorably within a saturated allergy OTC market, necessitating innovation and strategic marketing.
• Regulatory restrictions on pseudoephedrine significantly influence the supply chain and retail availability, impacting sales trajectories.
• Market growth is driven primarily by increasing allergy prevalence, consumer demand for convenience, and product innovation, though challenges like generic competition and regulatory hurdles threaten margins.
• The financial forecast indicates moderate growth potential, with emerging markets offering the most significant upside.
• Long-term success hinges on adaptive strategies aligned with evolving consumer preferences, regulatory environments, and competitive dynamics.

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FAQs

1. What factors distinguish ZYRTEC-D 12 HOUR from other allergy medications?
   Its extended 12-hour efficacy, combining cetirizine and pseudoephedrine, offers prolonged symptom relief unmatched by many shorter-acting formulations, optimizing consumer convenience.

2. How do regulatory restrictions on pseudoephedrine affect ZYRTEC-D’s market availability?
   Pseudoephedrine’s classification as a controlled substance imposes purchase limits, requires behind-the-counter storage, and complicates distribution logistics, potentially constraining sales.

3. What are the primary growth opportunities for ZYRTEC-D 12 HOUR?
   Expanding into emerging markets, leveraging formulation innovations, and capitalizing on rising allergy awareness provide avenues for growth.

4. How does competitive pressure influence ZYRTEC-D’s pricing strategy?
   The proliferation of generics necessitates balancing premium branding with pricing competitiveness to retain market share.

5. What are the main risks facing ZYRTEC-D’s market trajectory?
   Regulatory tightening, supply chain disruptions, evolving consumer preferences, and increasing generic competition pose significant challenges.

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References

[1] MarketResearch.com. "Global Allergy Therapeutics Market Report," 2023.
[2] World Allergy Organization. "Global Allergy Statistics," 2022.