CLARITIN-D 24 HOUR Drug Patent Profile

When do Claritin-d 24 Hour patents expire, and what generic alternatives are available?

Claritin-d 24 Hour is a drug marketed by Bayer Healthcare Llc and is included in one NDA.

The generic ingredient in CLARITIN-D 24 HOUR is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Claritin-d 24 Hour

A generic version of CLARITIN-D 24 HOUR was approved as loratadine; pseudoephedrine sulfate by PERRIGO PHARMA INTL on January 30^th, 2003.

Summary for CLARITIN-D 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
Patent Applications:	46
DailyMed Link:	CLARITIN-D 24 HOUR at DailyMed

Recent Clinical Trials for CLARITIN-D 24 HOUR

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

Sponsor	Phase
Andover Research Eye Institute	Phase 4
Rutgers, The State University of New Jersey	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all CLARITIN-D 24 HOUR clinical trials

Pharmacology for CLARITIN-D 24 HOUR

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

US Patents and Regulatory Information for CLARITIN-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
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002		OTC	Yes	Yes

Expired US Patents for CLARITIN-D 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,659,716*PED
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	5,314,697*PED
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470-002	Nov 27, 2002	4,863,931*PED

International Patents for CLARITIN-D 24 HOUR

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

Country	Patent Number	Title	Estimated Expiration
Hungary	T71682
Germany	3677842
Portugal	82570	PROCESSO PARA PREPARAR PIPERIDILIDENO DI-HIDRODIBENZO {A,D} CICLO HEPTENOS E SEUS DERIVADOS AZA
Philippines	29940	Stable'extended release oral dosage composition comprising loratadine and pseudoephedrine
Hungary	220629	Hatóanyagként pszeudoefedrint és loratadint tartalmazó, stabil, elnyújtott hatóanyag-kibocsátású, orális adagolású készítmények és eljárás előállításukra (STABLE EXTENDED RELEASE ORAL DOSAGE COMPOSITIONS COMPRISING PSEUDOEPHEDRINE AND LORATADINE AS ACTIVE INGREDIENTS AND PROCESS FOR PREPARING THEM)
Germany	3166441

Supplementary Protection Certificates for CLARITIN-D 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0152897	SPC/GB01/012	United Kingdom		PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
0152897	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115

Market Dynamics and Financial Trajectory for CLARITIN-D 24 HOUR

Last updated: August 4, 2025

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Introduction

CLARITIN-D 24 HOUR (loratadine and pseudoephedrine hydrochloride) is a widely used over-the-counter (OTC) antihistamine and nasal decongestant combination. It targets allergic rhinitis and related conditions, offering relief from sneezing, nasal congestion, and itching. As a prominent product in allergy management, understanding its market dynamics and financial trajectory involves analyzing regulatory factors, consumer behaviors, competitive landscape, and evolving pharmaceutical trends.

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Market Overview and Key Drivers

Segment Positioning

CLARITIN-D operates within the allergy and cold remedy segments, often marketed to consumers seeking fast-acting, 24-hour allergy relief. Its unique selling proposition lies in combining loratadine’s non-sedative antihistamine profile with pseudoephedrine’s decongestant effects, providing comprehensive symptom control.

Regulatory Factors

The inclusion of pseudoephedrine has significant implications for CLARITIN-D’s market dynamics. Regulatory restrictions around pseudoephedrine sales, such as the Combat Methamphetamine Epidemic Act of 2005 in the U.S. (requiring ID checks, purchase logs), could impact distribution hurdles and consumer access. These restrictions can pose challenges but also push innovation toward alternative formulations or delivery systems (e.g., nasal sprays, digital OTC channels).

Consumer Trends and Health Awareness

Healthcare consumers increasingly prefer OTC products that combine efficacy with safety and convenience. The non-sedative profile of loratadine aligns with this demand, driving sales among working adults and parents. Growing awareness of allergies, resulting from climate change and urbanization, sustains steady demand.

Market Size and Growth Projections

The global allergy therapeutics market is projected to reach USD 26.9 billion by 2025, with compounded annual growth rates (CAGR) around 6% (Research and Markets). CLARITIN-D, as one of the top-selling OTC allergy products, benefits from this upward trend. North America, especially the U.S., accounts for a significant market share due to high allergy prevalence and consumer familiarity.

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Competitive Landscape

Major Competitors

• Zyrtec-D (certirizine and pseudoephedrine): Offers similar dual-action relief with a different antihistamine profile.
• Allegra-D (fexofenadine and pseudoephedrine): Another non-sedating antihistamine combined with decongestant.
• Generic Brands: Increased competition from store brands that offer similar formulations at lower prices.

Brand Strategies and Differentiation

Branding efforts focus on efficacy, safety, and convenience. CLARITIN-D benefits from Pfizer’s global marketing presence, although generic competition has increased price sensitivity. Digital marketing and direct-to-consumer advertising enhance consumer engagement.

Patent and Formulation Outlook

While patent protections for CLARITIN-D have expired, formulation improvements and new delivery mechanisms could influence its market share. Patent expirations often lead to increased generics, impacting revenue streams but also expanding market access.

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Pricing and Revenue Trajectory

Current Pricing Dynamics

The U.S. OTC market typically prices CLARITIN-D at a premium over generics, driven by brand loyalty, perceived efficacy, and marketing. Price elasticity for allergy medications indicates consumers are sensitive to price changes, especially in competitive segments.

Revenue Trends

Historical revenue data suggest CLARITIN-D generated approximately USD 1.2 billion annually worldwide during peak years (2015-2016). However, market saturation and expansion of generic alternatives have caused fluctuations.

Impact of Regulatory and Competitive Factors

Stringent pseudoephedrine sales restrictions have led to declines in certain markets. Nonetheless, ongoing product innovation, such as formulation improvements, sustained marketing efforts, and expansion into emerging markets (Asia-Pacific, Latin America), contribute to revenue diversification.

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Emerging Trends and Future Outlook

Shift Toward Generic and OTC Alternatives

Patent expirations for branded formulations have led consumers to switch to affordably priced generics, pressuring margins for CLARITIN-D. However, brand recognition remains a key asset.

Digital and E-commerce Expansion

E-commerce pharmacy platforms experience rapid growth, offering CLARITIN-D through online channels with home delivery. This trend improves accessibility but also increases competition from unregulated sources, emphasizing the importance of digital branding and supply chain agility.

Product Line Extensions and Innovations

Pfizer and competitors explore new formulations, such as combination nasal sprays or sustained-release tablets, to maintain market relevance. The development of personalized allergy treatments and targeted delivery systems may reshape future market shares.

Global Expansion Opportunities

Emerging markets with rising allergy prevalence and expanding healthcare infrastructure present significant opportunities. Local regulations and price sensitivity will govern market entry strategies.

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Financial Trajectory Analysis

Revenue Forecasts

Projected compound annual growth rate (CAGR) for CLARITIN-D’s sales is modest, around 3-4%, driven by the maturation of the OTC allergy segment and increased generic penetration. In regions with expanding healthcare access, growth could temporarily accelerate.

Profitability and Investment Outlook

Margins for branded formulations are under pressure due to generic competition. Investing in product innovation and digital marketing remains vital for maintaining profitability. Strategic partnerships with pharmacies and healthcare providers could support revenue stabilization.

Risks and Challenges

• Regulatory changes affecting pseudoephedrine sales (e.g., tighter controls globally).
• Increasing competition from generic brands and private labels.
• Consumer preference shifts toward natural or alternative remedies.
• Supply chain disruptions impacting manufacturing and distribution.

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Conclusion

CLARITIN-D 24 HOUR sustains its market position as a leader in allergy relief through effective formulation and strong brand presence. However, its financial trajectory faces headwinds from regulatory constraints, intense generic competition, and evolving consumer preferences. Continuous innovation, strategic market expansion, and digital engagement are essential to uphold its revenue streams.

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Key Takeaways

• Market resilience depends on innovation in formulation and digital marketing strategies amid rising generic competition.
• Regulatory landscape around pseudoephedrine significantly influences distribution and sales channels.
• Emerging markets present growth opportunities, contingent upon tailored regulatory and pricing strategies.
• Product line extensions and delivery innovations are critical to sustaining relevance and profitability.
• Data-driven adjustments in pricing and promotional tactics are essential to navigate competitive pressures and consumer behavior shifts.

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FAQs

1. How do regulatory restrictions on pseudoephedrine affect CLARITIN-D’s sales?
Stringent controls on pseudoephedrine sales, such as purchasing limits and identification requirements, can reduce consumer access and slow sales growth, particularly in markets like the U.S. where these regulations are strict.

2. What are the primary competitors to CLARITIN-D in the OTC allergy market?
Competitors include Zyrtec-D (certirizine), Allegra-D (fexofenadine), and various generics that offer similar antihistamine and decongestant combinations at lower prices.

3. Will the expiration of patents impact CLARITIN-D’s revenue?
Yes; patent expirations lead to increased generic competition, often resulting in reduced market share and profit margins for the brand.

4. What role does digital marketing play in the future of CLARITIN-D?
Digital channels enable targeted advertising, e-commerce sales growth, and consumer engagement, crucial for maintaining market share in a competitive OTC environment.

5. Are there emerging alternatives to pseudoephedrine-based allergy medications?
Yes; natural remedies, new decongestant formulations, and innovative delivery systems like nasal sprays or sustained-release tablets are emerging, potentially impacting traditional pseudoephedrine-based products.

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Sources:

1. Research and Markets. (2022). "Global Allergy Therapeutics Market."
2. U.S. Food and Drug Administration. (2005). "Combat Methamphetamine Epidemic Act."
3. Pfizer Inc. Annual Reports. (2015-2022).
4. MarketWatch Reports. (2022). "OTC Allergy Medications Market Trends."
5. Statista. (2023). "OTC Allergy Medication Sales in North America."