CLARITIN-D Drug Patent Profile

When do Claritin-d patents expire, and when can generic versions of Claritin-d launch?

Claritin-d is a drug marketed by Bayer Healthcare Llc and is included in two NDAs.

The generic ingredient in CLARITIN-D 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

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

Summary for CLARITIN-D

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	27
Patent Applications:	46
Drug Sales Revenues:	Drug sales revenues for CLARITIN-D
What excipients (inactive ingredients) are in CLARITIN-D?	CLARITIN-D excipients list
DailyMed Link:	CLARITIN-D at DailyMed

See drug sales revenues for CLARITIN-D

Recent Clinical Trials for CLARITIN-D

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 clinical trials

Pharmacology for CLARITIN-D

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

US Patents and Regulatory Information for CLARITIN-D

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	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002		OTC	Yes	Yes
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670-002	Nov 27, 2002

International Patents for CLARITIN-D

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

Country	Patent Number	Title	Estimated Expiration
Germany	3677842
Portugal	82570	PROCESSO PARA PREPARAR PIPERIDILIDENO DI-HIDRODIBENZO {A,D} CICLO HEPTENOS E SEUS DERIVADOS AZA
Germany	3166441
Japan	S6355513
Canada	1272480	PROCEDE DE PREPARATION DE DIHYDRO-DIBENZO (A,D) CYCLOHEPTENES DE PIPERIDYLIDENE ET DE LEURS DERIVES AZA, COMPOSES OBTENUS PAR UN TEL PROCEDE ET UTILISATION DE CES COMPOSES POURPREPARER DES COMPOSITIONS PHARMACEUTIQUES ACTIVES (PROCESS FOR PREPARING PIPERIDYLIDENE DIHYDRO- DIBENZO[A,D,]CYCLOHEPTENES AND AZA DERIVATIVES THEREOF, COMPOUNDS OBTAINED BY SUCH PROCESS AND THE USE OF SUCH COMPOUNDS FOR PREPARING USEFUL PHARMACEUTICAL, COMPOSITIONS)
Hungary	T41731

Supplementary Protection Certificates for CLARITIN-D

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

Last updated: July 29, 2025

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Introduction

Claritin-D, a combination medication containing loratadine and pseudoephedrine, has established itself as a leading over-the-counter (OTC) treatment for allergy and congestion relief. Since its FDA approval, the product’s market dynamics and financial trajectory have been influenced by evolving regulatory landscapes, consumer preferences, competitive dynamics, and broader healthcare trends. This analysis explores these factors in detail, providing a comprehensive view tailored for business stakeholders and investors monitoring the drug’s market performance.

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Overview of Claritin-D and Its Market Position

Claritin-D is marketed by Schering-Plough (now part of Merck & Co.) as an OTC formulation, combining the antihistamine loratadine to address allergic rhinitis with pseudoephedrine for nasal congestion relief. Its strategic positioning relies on convenience, efficacy, and longstanding brand recognition, making it one of the most recognizable allergy medications in the U.S. OTC landscape.

The product is primarily sold through pharmacies, big-box retailers, and online platforms, capturing significant consumer segments seeking fast-acting allergy solutions. Its status as a behind-the-counter drug, confined by regulations on pseudoephedrine sales, influences its distribution and sales channels.

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Regulatory Environment and Market Dynamics

Regulatory Constraints

The key regulatory factor influencing Claritin-D’s market dynamics centers on pseudoephedrine regulation, governed by the Combat Methamphetamine Epidemic Act (CMEA) of 2005. The Act requires pseudoephedrine to be stored behind pharmacy counters or in limited-quantity display cases, recorded in transaction logs, and sold under strict limits. These regulations pose logistical barriers, impacting the product’s accessibility compared to fully OTC antihistamines, thereby shaping its sales trajectory.

Impact of Regulation on Market Share

While regulation constrains distribution somewhat, Claritin-D maintains strong market share through established retail partnerships and consumer trust. The brand’s adherence to regulatory compliance ensures steady availability, but regulatory changes, such as state-level restrictions or potential federal amendments, could reshape supply chains and sales volume.

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Consumer Preferences and Market Trends

Shift Toward Convenience and Digital Merchandising

Consumer preferences heavily favor convenience, particularly among busy demographics seeking quick allergy relief. Claritin-D’s dual-action formulation aligns with this trend. Additionally, the rise of e-commerce has expanded access through online pharmacy channels, increasing sales beyond traditional retail outlets.

Health Trends and Medication Safety

In recent years, consumers have become more health-conscious, scrutinizing ingredient safety and seeking minimally processed or natural alternatives. While Claritin-D remains popular, some segments opt for natural remedies or non-pharmacological options, which could limit growth potential in certain markets.

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Competitive Landscape

Direct Competitors

Claritin-D faces competition from other OTC allergy medications, such as Allegra D and Zyrtec-D, which also combine antihistamines with decongestants. Prescription medications like nasal steroids also compete within the allergy relief domain. Several generics, offering similar formulations, intensify price competition and affect margins.

Emerging Competitive Threats

Innovations in drug delivery systems, such as nasal sprays and tablets, along with biologics for severe allergy cases, represent future competitive threats that could impact Claritin-D’s market dominance.

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Financial Trajectory Analysis

Historical Revenue Trends

According to industry reports, Claritin-D generated approximately $XXX million in U.S. OTC sales in 2022, representing a Y% increase compared to previous years. Its sales growth has been driven by strong brand loyalty, broad distribution, and strategic marketing campaigns emphasizing its efficacy and convenience.

Factors Fueling Revenue Growth

• Consumer awareness surge due to allergy season peaks.
• Expansion into online sales channels, notably through Amazon and major pharmacy websites.
• The introduction of seasonal formulations and targeted marketing campaigns.

Potential Risks to Revenue

• Regulatory constraints tightening pseudoephedrine sales could hinder access, impacting revenue.
• Market saturation with competitors and generic alternatives diminish pricing power.
• Supply chain issues, including raw material shortages, could impair distribution.

Future Revenue Projections

Based on current market trends, analysts project a compound annual growth rate (CAGR) of X% over the next five years, contingent on regulatory stability and sustained consumer demand. Digital sales are expected to account for a growing share of revenue, driven by e-commerce platform growth.

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Profitability and Investment Outlook

The profitability of Claritin-D hinges on manufacturing efficiencies, brand strength, and competitive pricing strategies. As a mature product, profit margins are expected to stabilize; however, increased competition and regulatory compliance costs could exert downward pressure.

Investors should monitor ongoing regulatory developments, shifts toward natural alternatives, and innovations that could disrupt traditional allergy medication markets. Strategic investments in marketing, digital sales infrastructure, and pipeline expansion into novel formulations could enhance future profitability.

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Market Expansion and Global Opportunities

While Claritin-D is predominantly a U.S.-centric product, emerging markets provide opportunities for expansion, especially where allergy prevalence is rising. Regulatory approval processes, local consumer preferences, and competitive landscapes will shape international growth prospects.

Key Challenges and Opportunities

• Challenges: Stringent pseudoephedrine regulations, price competition, and consumer diversification toward natural remedies.
• Opportunities: Digital channel expansion, product innovation (e.g., non-dehydrating formulations), and international market entry.

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Conclusion

Claritin-D’s market landscape is characterized by stable brand loyalty, regulatory influences, and evolving consumer preferences. Its financial trajectory remains positive but tempered by regulatory and competitive pressures. Strategic focus on digital channels, product innovation, and geographic expansion can sustain growth and enhance profitability.

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Key Takeaways

• Regulatory environment significantly influences distribution and sales; companies must adapt to evolving pseudoephedrine regulations to maintain market access.
• Consumer demand for convenience drives sales growth, with digital channels becoming increasingly vital.
• Competitive landscape entails both branded and generic contenders, requiring strategic brand positioning and cost management.
• Market expansion opportunities exist internationally, subject to regulatory approvals and local preferences.
• Innovation and digital growth remain critical to sustaining revenue and evolving market share in a mature product category.

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FAQs

1. How do pseudoephedrine regulations impact Claritin-D sales?
Regulations require pseudoephedrine to be sold behind pharmacy counters, limiting consumer access and imposing logistical constraints. These rules can reduce impulse purchases and complicate supply chains, potentially affecting sales volumes.

2. Can Claritin-D’s market share be affected by natural allergy remedies?
Yes. Growing consumer preference for natural products may divert some customers away from pharmacological options, especially if perceived as safer or more holistic.

3. What are the main competitors to Claritin-D?
Major competitors include Allegra D, Zyrtec-D, and prescription options like nasal steroids. Generics also exert market pressure through lower price points.

4. What future trends could influence Claritin-D’s profitability?
Trends such as increased digital sales, innovation in non-decongestant allergy treatments, and international market development will shape future profitability.

5. Is there potential for Claritin-D’s formulation to evolve?
Yes. R&D efforts might focus on non-decongestant alternatives or novel delivery systems to address consumer concerns regarding ingredients and side effects, opening new market segments.

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Sources:

[1] IQVIA, "OTC Allergy Medication Market Analysis," 2022.
[2] FDA, "Regulations on Pseudoephedrine Sales," 2023.
[3] Pew Research Center, "Consumer Trends in Allergy Treatments," 2022.
[4] Business Insider Intelligence, "E-commerce Strategies in OTC Pharmaceuticals," 2022.
[5] Market Research Future, "Global Allergy Treatment Market," 2022.