CLARITIN Drug Patent Profile

Which patents cover Claritin, and when can generic versions of Claritin launch?

Claritin is a drug marketed by Bayer Healthcare Llc and is included in eight NDAs.

The generic ingredient in CLARITIN 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

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

Summary for CLARITIN

US Patents:	0
Applicants:	1
NDAs:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	27
Patent Applications:	4,117
Drug Sales Revenues:	Drug sales revenues for CLARITIN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLARITIN
What excipients (inactive ingredients) are in CLARITIN?	CLARITIN excipients list
DailyMed Link:	CLARITIN at DailyMed

See drug sales revenues for CLARITIN

Recent Clinical Trials for CLARITIN

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 clinical trials

US Patents and Regulatory Information for CLARITIN

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	loratadine	CAPSULE;ORAL	021952-001	Jun 16, 2008		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN HIVES RELIEF REDITAB	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	020704-003	Nov 19, 2003		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN REDITABS	loratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021993-001	Dec 12, 2006		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002		OTC	Yes	Yes
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET, CHEWABLE;ORAL	021891-002	Nov 21, 2018		OTC	Yes	Yes

Expired US Patents for CLARITIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	TABLET;ORAL	019658-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002
Bayer Healthcare Llc	CLARITIN	loratadine	SYRUP;ORAL	020641-002	Nov 27, 2002

International Patents for CLARITIN

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

Country	Patent Number	Title	Estimated Expiration
Ireland	811328
Spain	2096560
Malaysia	123325	STABILIZED ANTIHISTAMINE SYRUP
Norway	20006079
Japan	H0572910
Japan	H03502696

Supplementary Protection Certificates for CLARITIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0152897	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
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.
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

Market Dynamics and Financial Trajectory for Claritin (Loratadine)

Last updated: July 31, 2025

Introduction

Claritin, the brand name for loratadine, is an antihistamine medication widely used to treat allergy symptoms, including sneezing, runny nose, and itchy eyes. Launched initially by Schering-Plough in 1993 and later acquired by Merck & Co., Claritin has become one of the leading over-the-counter (OTC) allergy medications globally. Its market performance, driven by evolving consumer preferences, regulatory landscapes, and competitive dynamics, provides critical insights into its ongoing and projected financial trajectory.

This analysis examines the key drivers shaping Claritin’s market landscape and forecasts its financial prospects amid robust competition, regulatory pressures, and evolving consumer health trends.

Market Overview and Growth Drivers

Global Allergy Market Context

The global allergy therapeutics market is projected to reach approximately USD 36 billion by 2027 at a compound annual growth rate (CAGR) of 4.8% [1]. Increasing awareness of allergy-related health issues, rising prevalence of allergic rhinitis, and a growing aging population significantly fuel demand. Claritin, positioned as a non-sedating antihistamine, benefits from these drivers by catering to consumer preferences for effective, OTC allergy relief.

Product Positioning and Consumer Preferences

Claritin's non-drowsy profile distinguishes it from first-generation antihistamines. Its favorable safety profile, ease of access as an OTC asset, and extensive global distribution contribute to its sustained market presence. The shift towards OTC formulations has been pivotal, enabling Claritin to capitalize on consumer demand for self-medication, reducing reliance on prescriptions.

Regulatory and Patent Lifecycle Dynamics

Initially protected by patent exclusivity in various markets, Claritin faced the imminent threat of generic entry after patent expiry, notably in the U.S. in 2002. Post-patent, generic loratadine products flooded the market, causing substantial revenue erosion for the brand. Merck’s strategic shift towards over-the-counter availability in 2002 rejuvenated its market share, yet price competition and market saturation remain persistent challenges.

Market Challenges and Competitive Landscape

Generic Competition

The entry of numerous generic loratadine formulations has diluted Claritin’s market share significantly. Generics often price at a substantial discount, exerting downward pressure on brand-name sales.

Brand Differentiation and Consumer Loyalty

Despite intense price competition, Claritin's brand recognition and perception as a trusted, effective product sustain some consumer loyalty. However, rising prevalence of private label alternatives further pressure margins.

Regulatory and Intellectual Property Challenges

Ongoing patent litigations and regulatory hurdles, especially in emerging markets, influence Claritin’s distribution and pricing strategies. Additionally, shifts in regulatory policies favoring generics accelerate market entry for alternative formulations.

Emerging Competition and Innovation

Newer classes of allergy medications, such as leukotriene receptor antagonists and biologics, pose future competitive threats, particularly for severe allergy cases. While Claritin remains dominant in mild to moderate cases, innovation-driven competition could impact its financial trajectory.

Financial Trajectory and Forecasting

Historical Revenue Trends

Historically, Claritin reached peak global sales of approximately USD 3 billion in the early 2000s post-patent expiration, primarily driven by OTC sales in the U.S. (where it generated around USD 1 billion annually) [2].

Current Revenue Streams

Today, Claritin’s revenue primarily stems from the OTC market in North America, Europe, and select Asian countries. Its global sales are estimated to hover around USD 1.2 billion annually, with North American markets representing over 60% of total revenue.

Forecasted Growth and Challenges

Given current market trends, Claritin’s revenue is expected to decline modestly over the next five years unless strategic innovations or market repositionings occur.

Factors influencing this projection include:

• The rise of generic loratadine: Market share for Claritin may decrease by approximately 2–3% annually due to price competitiveness of generics [3].

• Consumer shift towards newer allergy treatments: Especially biologics and combination therapies for severe allergies could marginalize Claritin’s market segment.

• Regulatory pressures and patent expirations: Future patent protections are limited, increasing generic penetration.

Potential Growth Strategies

Merck & Co. and other stakeholders might pursue strategies such as:

• Line Extensions: Combining loratadine with other active ingredients (e.g., pseudoephedrine) to target broader symptom profiles.

• Geographic Expansion: Increasing penetration in emerging markets, where OTC allergy medications are gaining acceptance.

• Digital and Consumer Engagement: Leveraging digital marketing to reinforce brand loyalty.

Financial Outlook Summary

While Claritin retains a considerable market share, its revenue trajectory is expected to decline at a CAGR of approximately -2% to -3% over the next five years, primarily due to generic competition and market saturation. However, with strategic repositioning, such as product line extensions and market expansion, a stabilization or limited growth is feasible, contingent on regulatory environments and consumer preferences.

Market Risks and Opportunities

Risks

• Accelerated entry of generics and private label competitors.
• Regulatory restrictions impacting OTC marketing.
• Emergence of more effective or preferred allergy treatments.
• Market saturation in mature regions.

Opportunities

• Expansion into underserved geographies.
• Innovation through combination therapies.
• Digital marketing to reinforce brand relevance.
• Development of next-generation formulations with improved efficacy or convenience.

Conclusion

Claritin’s market dynamic landscape demonstrates resilience rooted in brand equity and consumer trust but faces mounting challenges from commoditization and competition. Its financial trajectory suggests gradual decline absent strategic intervention. Stakeholders that leverage market expansion, product innovation, and digital engagement can sustain or enhance its market relevance in a highly competitive environment.

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Key Takeaways

• Market Position: Claritin remains a leading OTC allergy medication, but declining revenues due to patent erosion and generic competition are evident.

• Growth Drivers: Consumer demand for non-drowsy, effective allergy relief sustains demand; however, innovation and market expansion are vital to counteract saturation.

• Competitive Challenges: Generic loratadine formulations dominate pricing, pressuring margins, with newer treatments emerging for severe allergies.

• Financial Outlook: Expect a modest revenue decline of approximately 2-3% CAGR over the next five years. Strategic growth hinges on geographic expansion and product line innovations.

• Strategic Recommendations: Firms should focus on emerging markets, invest in product extensions, and harness digital marketing to maintain relevance and profitability.

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FAQs

1. What are the main factors affecting Claritin’s market share?
   Generic competition, pricing, consumer preferences shifting towards newer treatments, and regulatory policies influence Claritin's market share.

2. How has patent expiration impacted Claritin globally?
   Post-patent expiry, generic loratadine formulations flooded markets, significantly reducing Claritin's revenue, especially in the U.S.

3. What strategies can preserve Claritin’s relevance amid competition?
   Product innovations, geographic expansion, digital marketing, and developing combination therapies can help sustain market presence.

4. Is Claritin likely to regain market dominance?
   Without significant innovation or strategic repositioning, Claritin's dominance is unlikely; market trends favor generics and newer therapies.

5. What emerging markets present opportunities for Claritin?
   Countries in Asia, Latin America, and Eastern Europe with growing OTC medication access and allergy awareness offer growth prospects.

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Sources:

[1] Fortune Business Insights. (2022). Global Allergy Therapeutics Market Size, Share & Industry Analysis.
[2] Merck & Co. financial reports. (2002–2022).
[3] MarketWatch. (2022). Generic loratadine market analysis.