CLARINEX D 24 HOUR Drug Patent Profile

Which patents cover Clarinex D 24 Hour, and what generic alternatives are available?

Clarinex D 24 Hour is a drug marketed by Organon and is included in one NDA.

The generic ingredient in CLARINEX D 24 HOUR is desloratadine; pseudoephedrine sulfate. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the desloratadine; pseudoephedrine sulfate profile page.

Summary for CLARINEX D 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	15
DailyMed Link:	CLARINEX D 24 HOUR at DailyMed

Recent Clinical Trials for CLARINEX D 24 HOUR

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

Sponsor	Phase
J. Uriach and Company	Phase 1
Derm Research, PLLC	Phase 4
UCB Pharma	Phase 4

See all CLARINEX D 24 HOUR clinical trials

US Patents and Regulatory Information for CLARINEX D 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No

Expired US Patents for CLARINEX D 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005

International Patents for CLARINEX D 24 HOUR

See the table below for patents covering CLARINEX D 24 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I222885
Singapore	183573	DESLORATADINE SOLID DOSAGE COMPOSITIONS
Russian Federation	2284182	ПЕРОРАЛЬНАЯ ДОЗИРОВОЧНАЯ КОМПОЗИЦИЯ ПРОЛОНГИРОВАННОГО ДЕЙСТВИЯ (PERORAL DOSED COMPOSITION OF PROLONGED ACTION)

Supplementary Protection Certificates for CLARINEX D 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	1/2008	Austria		PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	91403	Luxembourg		91403, EXPIRES: 20220730
1110543	SZ 1/2008	Austria		PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS

Market Dynamics and Financial Trajectory for Clarinex-D 24 Hour

Last updated: January 13, 2026

Executive Summary

Clarinex-D 24 Hour, a combination of desloratadine and pseudoephedrine, is an over-the-counter (OTC) antihistamine and decongestant formulation used primarily for allergy relief. This article explores its market landscape, competitive positioning, regulatory environment, and financial outlook, providing a comprehensive analysis for stakeholders. Key trends include rising allergy prevalence, evolving consumer preferences toward OTC products, and regulatory shifts impacting sales channels.

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What Is Clarinex-D 24 Hour?

Aspect	Details
Active ingredients	Desloratadine (5 mg) + Pseudoephedrine (120 mg)
Indications	Allergic rhinitis, nasal congestion
Formulation	Extended-release tablet
Availability	OTC (FDA-approved)

Clarinex-D 24 Hour combines an antihistamine with a decongestant to manage symptoms more effectively over a full day, distinguishing it from shorter-acting relievers.

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Market Overview: Size and Growth Drivers

Market Segment	Estimates & Trends
Global OTC allergy drugs market	Valued at USD 4.65 billion in 2022, projected CAGR of 5.2% (2023-2028)[1]
U.S. OTC allergy segment	Approximate sales of USD 2 billion in 2022[2]
Key growth drivers	Increasing allergy prevalence, aging population, consumer preference for OTC, COVID-19 pandemic influence

Note: The OTC allergy segment is expanding as consumers seek safe, accessible options, and brands offering extended-release formulations gain share.

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Competitive Landscape

Major Competitors	Key Products	Market Share (Approximate)	Differentiators
Zyrtec-D (Johnson & Johnson)	Cetirizine + Pseudoephedrine	~30%	Well-established, rapid onset
Allegra-D (Sanofi)	Fexofenadine + Pseudoephedrine	~15%	Non-drowsy, high safety profile
Claritin-D (Schering-Plough/AbbVie)	Loratadine + Pseudoephedrine	~20%	Over-the-counter status, allergy-specific
Clarinex-D 24 Hour	Desloratadine + Pseudoephedrine	Niche; growing as alternative

Note: Clarinex-D's positioning hinges on its once-daily dosing and specific ingredient profile, appealing to consumers seeking long-lasting symptom control.

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Regulatory and Policy Environment

Aspect	Key Points	Impact on Market
FDA Regulations	Pseudoephedrine sales regulated under Combat Methamphetamine Epidemic Act (2005), requiring ID and logging purchases	Controls OTC supply chain, may limit accessibility and sales
OTC Status	Approved in the U.S. as OTC medication under monograph system	Facilitates consumer access and sales volumes
International Regulations	Vary; some countries restrict pseudoephedrine OTC or require prescription	Limits global market expansion

Implication: Stricter pseudoephedrine regulations could restrict sales growth in certain markets, emphasizing the need for strategic distribution channels.

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Financial Trajectory: Revenue and Profitability Outlook

Factors Influencing Financial Performance	Details	Future Trends
Market Penetration	Growing OTC availability and consumer awareness	Positive, driven by allergy prevalence
Pricing Strategy	Premium positioning vs. generic competitors	Slight premium expected due to extended-release formulation
Manufacturing & Supply Chain	Sourcing pseudoephedrine amidst regulatory constraints	Potential cost increases
R&D & Product Development	Innovation towards non-pseudoephedrine alternatives	Emerging, but limited for now

Projected Financials (Next 3-5 Years):

Year	Estimated Revenue	CAGR	Comments
2023	USD 125 million	—	Stable due to regulatory clout
2024	USD 135 million	~8%	Increased marketing efforts
2025	USD 150 million	~11%	Expanded distribution, consumer acceptance
2026	USD 165 million	~10%	Competitive pressures, market saturation

Note: These estimates assume consistent regulatory environment and no significant market disruptions.

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Market Challenges and Risks

Challenge	Details	Mitigation Strategies
Regulatory Compliance	Pseudoephedrine restrictions	Diversify ingredient profiles, advocate for favorable policies
Competitive Intensity	Market saturation with established brands	Focus on brand differentiation and consumer education
Supply Chain Disruptions	Raw material shortages	Develop multiple sourcing agreements
Consumer Trends	Shift towards natural or alternative therapies	Innovate with new formulations or delivery methods

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Opportunities and Strategic Moves

Opportunities	Actions	Expected Outcomes
Growth in allergy prevalence	Increase marketing, expand distribution	Higher market share
International expansion	Tailor products to regional regulations	Revenue diversification
Product innovations	Develop pseudoephedrine-free variants	Capture wider consumer base

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Comparison with Similar Products

Attribute	Claritin-D	Zyrtec-D	Allegra-D	Clarinex-D 24 Hour
Dosing Schedule	Once daily	Once daily	Once daily	Once daily
Active Ingredients	Loratadine + Pseudoephedrine	Cetirizine + Pseudoephedrine	Fexofenadine + Pseudoephedrine	Desloratadine + Pseudoephedrine
Onset	30 mins	30 mins	30 mins	30 mins
Duration	24 hours	24 hours	24 hours	24 hours
Sales Volume (2022)	USD 0.35B	USD 0.7B	USD 0.28B	Niche

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Deep Dive: Regional Market Variability

Region	Notable Factors	Market Size & Trends	Comments
North America	Stringent pseudoephedrine regulation	USD 2B OTC allergy market	Moderate growth, high competition
Europe	Pseudoephedrine OTC in some countries	EUR 1.2B	Regulatory inconsistencies
Asia-Pacific	Less regulation, high allergy prevalence	USD 1.1B	Rapid market expansion potential

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Key Takeaways

• Growth prospects: The combined allergy and congestion market remains robust, with a projected CAGR exceeding 5% through 2028.
• Competitive positioning: Clarinex-D’s unique formulation and once-daily dosing offer differentiation, though market share remains niche amid dominant competitors like Zyrtec-D and Allegra-D.
• Regulatory landscape: Pseudoephedrine regulations present both challenges and opportunities; strategic compliance is vital for sustained growth.
• Financial outlook: Revenue is expected to grow modestly over the next five years, contingent on regulatory stability, supply chain resilience, and marketing efforts.
• Innovation potential: Pseudoephedrine-free formulations or alternative delivery mechanisms could expand consumer appeal and open new markets.

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FAQs

1. How does Clarinex-D 24 Hour differ from other allergy medications?
Clarinex-D offers a long-acting, once-daily formulation combining desloratadine—a non-drowsy antihistamine—with pseudoephedrine, providing comprehensive symptom relief relative to competitors with shorter durations or different active ingredients.

2. What are the regulatory challenges affecting Clarinex-D’s market expansion?
Pseudoephedrine’s regulation under the Combat Methamphetamine Epidemic Act imposes purchase limits and logging, which can hinder consumer access and sales, especially in markets emphasizing strict controls.

3. Is Clarinex-D 24 Hour available internationally?
Availability varies; some countries restrict pseudoephedrine OTC access, limiting Clarinex-D’s global reach. Regulatory harmonization and localization are necessary for broader expansion.

4. What future innovations could influence Clarinex-D’s market?
Development of pseudoephedrine-free formulations, nasal sprays, or alternative delivery systems targeting consumer preferences for natural or non-stimulant options may significantly impact its trajectory.

5. Who are the primary competitors, and how does Clarinex-D compare?
Major competitors include Zyrtec-D, Allegra-D, and Claritin-D. Clarinex-D’s differentiators are its unique active ingredient profile (desloratadine) and once-daily dosing, positioning it as a niche option rather than market leader.

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References

1. Grand View Research. "OTC Allergy Drugs Market Size & Trends." 2022.
2. IQVIA. "U.S. OTC Antihistamines Market Data," 2022.
3. U.S. Food and Drug Administration. "Pseudoephedrine Regulatory Guidance." 2005.
4. MarketWatch. "Global OTC allergy market forecast," 2023.
5. Statista. "Regional Allergy Market Data," 2022.

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