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:	16
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
UCB Pharma	Phase 4
Derm Research, PLLC	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	7,820,199*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	4,659,716*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,618,649*PED
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005	7,214,683*PED

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
Australia	707541
Japan	H0859657	PIPERIDIDENEDIHYDRODIBENZO(A,B)CYCLOHEPTENE COMPOUND AND MEDICINE COMPOSITION CONTAINING SAME
Hungary	0004988
Norway	20006503

Supplementary Protection Certificates for CLARINEX D 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
1110543	CA 2008 00010	Denmark		PRODUCT NAME: KOMBINATION OMFATTENDE DESLORATADIN OG PSEUDOEPHEDRIN, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT IFOELGE NEDENSTAENDE GRUNDPATENT, HERUNDER PSEUDOEPHEDRIN SOM SULFAT
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543	300328	Netherlands

Market Dynamics and Financial Trajectory for CLARINEX D 24 HOUR

Last updated: July 29, 2025

Introduction

CLARINEX D 24 HOUR, a combination antihistamine and decongestant drug, is a prominent OTC medication primarily used for allergic rhinitis and nasal congestion relief. Its active ingredients typically include loratadine, a second-generation antihistamine, and pseudoephedrine, a sympathomimetic decongestant. Understanding its market dynamics and financial trajectory is crucial for stakeholders navigating a competitive landscape influenced by regulatory, demographic, and technological shifts.

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Product Overview and Therapeutic Profile

CLARINEX D 24 HOUR combines loratadine with pseudoephedrine, offering 24-hour symptomatic relief. Its pharmacological profile aims at minimizing sedation associated with first-generation antihistamines while providing effective nasal congestion relief. This dual-action formulation positions it as a preferred OTC choice for consumers seeking convenience and sustained symptom control.

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Market Dynamics

1. Market Size and Growth Drivers

The global allergy drug market, estimated to reach over USD 21 billion by 2025[1], is driven by rising allergy prevalence, increased consumer health awareness, and the expanding OTC segment. CLARINEX D 24 HOUR exploits this growth, targeting consumers with persistent allergic symptoms who prefer long-acting formulations.

The rising incidence of allergic rhinitis, estimated at 10-30% globally, predominantly in urbanized populations, sustains demand for long-acting antihistamines[2]. The product’s 24-hour efficacy caters to this demographic, facilitating adherence and convenience.

2. Regulatory Environment

Regulatory frameworks significantly influence market accessibility and sales. Pseudoephedrine's classification under regulations like the Combat Methamphetamine Epidemic Act (CMEA) in the US necessitates behind-the-counter placement and purchaser identification, potentially impacting over-the-counter sales[3]. Variability in such regulations across countries creates differential market opportunities and compliance costs.

Recent trends favoring regulatory restrictions on pseudoephedrine due to misuse concerns could limit product availability or prompt formulation modifications, affecting sales and profitability. Conversely, regulatory approval for combination OTC products across markets enhances consumer access.

3. Competitive Landscape

CLARINEX D 24 HOUR faces competition from various antihistamines and combination therapies, including:

• Brand Competitors: Allegra D, Zyrtec-D, Nasacort Allergy 24HR.
• Generic Entries: Multiple generics offer similar formulations at reduced prices, intensifying price competition.
• Alternative Treatments: Non-pharmacological measures and newer biological therapies in severe cases.

Generic proliferation often results in downward pressure on pricing, affecting revenue margins but widening consumer access.

4. Consumer Preferences and Trends

Current consumer trends favor long-acting, non-sedating formulations with minimal side effects. The convenience of 24-hour dosing aligns with these preferences, supporting sustained sales.

However, increasing health literacy prompts consumers to seek drug safety and transparency, which can influence brand loyalty and prescribing habits. The rising demand for "natural" or alternative remedies could also temper growth in pharmacological allergy treatments.

5. Impact of Pandemics and Healthcare Disruptions

The COVID-19 pandemic underscored the importance of OTC medications for chronic conditions, including allergies, as healthcare resource constraints limited in-person consultations. This scenario temporarily boosted OTC sales but also heightened scrutiny regarding medication safety and efficacy.

Emerging health crises can both present opportunities for increased OTC drug consumption and introduce supply chain disruptions, which may impact sales trajectories.

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Financial Trajectory

1. Revenue Trends

Global sales of allergy medications, including CLARINEX D 24 HOUR, are expected to sustain growth at a CAGR of approximately 4-6% through 2030[1]. In mature markets like the US and Europe, revenues may stabilize or experience moderate decline due to saturation, while emerging markets present high-growth opportunities.

2. Pricing and Profitability

Pricing strategies adapt to competitive pressures and regulatory changes. Brand loyalty and patent protections can sustain premium pricing, but patent expirations and generic entries tend to compress margins over time.

Manufacturers increasingly leverage vertical integration, expanding distribution channels and digital marketing to optimize profit margins.

3. R&D and Pipeline Considerations

Investment in formulation improvements, such as non-sedating options or allergy immunotherapies, can influence long-term sales. Market players with robust pipelines may introduce next-generation formulations to address safety and efficacy concerns, shaping future competitive dynamics.

4. Regulatory and Legal Factors Impacting Financials

Regulatory restrictions on pseudoephedrine and evolving patent landscapes directly affect revenue streams. Legal challenges, patent expirations, or successful patent litigations can significantly influence market exclusivity and revenue projections.

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Opportunities and Challenges

Opportunities

• Expanding Geographies: Rising allergy prevalence and increasing healthcare infrastructure in Asia-Pacific and Latin America offer significant expansion potential.
• Formulation Innovation: Development of pseudoephedrine-free alternatives mitigates regulatory hurdles and appeals to health-conscious consumers.
• Digital Sales Channels: Growth of e-commerce facilitates direct-to-consumer access, especially in pandemic-affected markets.

Challenges

• Regulatory Restrictions: Heightened regulations on pseudoephedrine impose distribution and compliance burdens.
• Generic Competition: Market saturation with generics reduces pricing power.
• Consumer Preference Shifts: Trends toward natural and organic remedies may impact traditional pharmacological products.

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Strategic Recommendations

Stakeholders should prioritize:

• Regulatory Intelligence: Monitor evolving legislation regarding pseudoephedrine and combination products.
• Innovation: Invest in developing pseudoephedrine-free formulations with comparable efficacy.
• Market Diversification: Focus on emerging markets with growing allergy prevalence.
• Brand Differentiation: Emphasize safety, efficacy, and convenience in marketing strategies.
• Digital Engagement: Leverage e-commerce platforms for enhanced reach and consumer engagement.

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Key Takeaways

• CLARINEX D 24 HOUR benefits from longstanding demand for long-acting allergy relief but faces challenges from regulatory controls and generic competition.
• The global allergy drug market will maintain moderate growth, driven by rising allergy prevalence and consumer demand for OTC solutions.
• Price competition and patent expirations will likely compress margins over time; innovation and market expansion are vital.
• Regulatory landscapes vary internationally, influencing product availability and sales strategies.
• Opportunities exist in emerging markets and formulation innovation, but companies must navigate regulatory and consumer trends carefully.

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FAQs

Q1: How do regulatory restrictions on pseudoephedrine affect CLARINEX D 24 HOUR sales?
A: Strict regulations, such as behind-the-counter placement and purchase limits, can reduce overall accessibility, impacting sales volumes. Manufacturers may need to develop pseudoephedrine-free alternatives or reformulate to mitigate these effects.

Q2: What are the main competitive threats to CLARINEX D 24 HOUR?
A: Generic equivalents, other combination antihistamines, and emerging non-pharmacological treatments pose competitive threats by offering similar efficacy at lower prices or alternative options.

Q3: How is the growth in e-commerce influencing the market for allergy medications?
A: E-commerce expands distribution channels, reaches wider demographics, and facilitates direct-to-consumer marketing, thus increasing sales potential but also requiring compliance with online pharmaceutical regulations.

Q4: Are there significant patent protections or exclusivities for CLARINEX D 24 HOUR that impact its market?
A: Patent protections have generally expired or are nearing expiry, leading to increased generic competition and pressure on pricing and margins.

Q5: What future developments could impact the financial trajectory of CLARINEX D 24 HOUR?
A: Innovations in formulation, regulatory changes, shifts in consumer preferences, and expansion into emerging markets will significantly influence future sales and profitability.

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References

[1] MarketsandMarkets, "Allergy Drugs Market," 2022.
[2] Bousquet, J., et al., "Allergic Rhinitis," Nature Reviews Disease Primers, 2020.
[3] US DEA, "Pseudoephedrine Sales Regulations," 2021.