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
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	TABLET;ORAL	019658-003	Nov 19, 2003		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
Israel	63122	ANTIHISTAMINIC TRICYCLIC ALKYLCARBAMIC AND SULFAMIC ACID ESTERS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Ireland	811328
Australia	600665
South Korea	900001853
Ireland	51303	NOVEL ANTIHISTAMINES
Costa Rica	6035	JARABE ANTIHISTAMINICO ESTABILIZADO
Austria	61364

Supplementary Protection Certificates for CLARITIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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.

Market Dynamics and Financial Trajectory for Claritin (Loratadine)

Last updated: December 29, 2025

Executive Summary

Claritin (generic name: loratadine) is a leading antihistamine used primarily to treat allergic rhinitis and chronic urticaria. Since its market launch in the late 1990s, Claritin has maintained a robust market presence despite increasing generic competition. This report provides an in-depth analysis of Claritin’s market dynamics, its financial trajectory, competitive landscape, regulatory environment, and future outlook, helping stakeholders make informed business and investment decisions.

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What Are the Core Market Drivers for Claritin?

Factor	Impact	Details
Prevalence of Allergic Conditions	High	Globally, allergic rhinitis affects approximately 10-30% of the population. Chronic urticaria impacts about 1-3%. [1]
Consumer Preference for Non-Drowsy Antihistamines	Significant	Claritin’s non-drowsy profile makes it a preferred choice.
Brand Recognition and Credibility	Moderate	Claritin has established strong brand loyalty and healthcare provider trust.
Regulatory Environment	Neutral to Positive	Approval and patent protections in key markets influence pricing and exclusivity.
Insurance Coverage and Reimbursement	Critical	Becomes a determining factor for OTC and Rx sales.

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How Has Claritin’s Market Share Evolved?

Period	Market Share (Global)	Key Trends	Notes
1990s	Dominant	Launch of Claritin; rapid growth	Patent-led market exclusivity
Early 2000s	Peak (~15%) in US OTC**	Entry of generics, erosion of brand dominance	Patents expired in the US (2002–2003)
2004–2010	Market decline	Increased generic competition, price sensitivity	Shift from Rx to OTC sales
2010s–Present	Stabilized (~5–8%) in US OTC	Market saturation; new formulations; emerging markets	Continued generics competition, OTC dominance

Note: Claritin's global market share varies substantially between regions, with notable dominance in North America, Europe, and parts of Asia.

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What Is Claritin’s Financial Trajectory?

Revenue Trends

Year	Global Revenue (USD)	Notes
1993	Launch, approximate $2B	Rapid growth driven by US market
2000	$4.8B (peak revenue)	Peak during patent protection; significant OTC sales
2002–2003	Decline begins	Patent cliff causes generic entry
2004–2010	Revenue declines (~50%)	Increased generic penetration reduces revenue
2015	~$1.5B (post-availability of generics)	Stabilization post-generic adoption
2020	$1.2B	Moderate sales within a crowded antihistamine market

Profitability

Aspect	Trend/Observation
Gross Margin	Historically high (~70%) during patent exclusivity; declines with generics.
Operating Margin	Reduced over time, from high teens to mid-single digits post-generic competition.
Research & Development	Limited, as Claritin is a mature drug with minimal innovation.

Key Revenue Sources

Source	Share (%)	Details
Prescription (Rx)	~45%	Prior to OTC switch; now primarily in select markets or specific indications.
Over-the-Counter (OTC)	~55%	Dominant revenue stream, especially in mature markets.

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How Do Current Market Dynamics Shape Claritin’s Future?

Patent and Regulatory Landscape

Factor	Status	Implications
Patent Expirations	US patent expired (2002), generic entry since	Limited exclusivity, pressing generic pricing and market share.
Regulatory Approvals	Ongoing approvals for OTC switch in additional markets	Potential growth in emerging markets; limited impact in mature regions without new formulations.

Competition and Market Saturation

Primary Competitors	Market Share (%)	Notes
Generics (Loratadine)	80–90% (US)	Widely available at lower prices.
Other Antihistamines	E.g., Cetirizine (Zyrtec), Fexofenadine (Allegra); combined 10–15%	Differentiated by onset, duration, and side effect profiles.

New Product Development and Formulation Strategies

Efforts	Impact
Formulation Innovations	Extended-release formulations, combination therapies to address unmet needs.
Brand Revitalization	Marketing campaigns emphasizing non-drowsiness, safety, and efficacy.
Market Expansion	Entry into emerging markets like Asia-Pacific, Latin America via OTC and prescription channels.

Emerging Market Opportunities

Region	Growth Potential	Challenges
Asia-Pacific	High; rising allergy awareness	Regulatory differences; price sensitivity
Latin America	Moderate; expanding healthcare coverage	Distribution infrastructure
Africa	Growing due to urbanization	Affordability; awareness campaigns

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How Does Claritin Compare with Its Competitors?

Parameter	Claritin (Loratadine)	Zyrtec (Cetirizine)	Allegra (Fexofenadine)	Generic Loratadine
Drowsiness Profile	Non-drowsy	Slightly drowsy	Non-drowsy	Non-drowsy
Onset of Action	1–3 hours	1 hour	1–2 hours	1–3 hours
Duration	24 hours	24 hours	24 hours	24 hours
Pricing (USD)	Premium (~$10/dose)	Moderate (~$8/dose)	Moderate (~$8/dose)	Low (~$2–$4/dose)
Market Position	Established brand	Competitive alternative	Alternative in OTC segment	Price leader

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What Are the Regulatory and Policy Considerations?

Area	Details	Implication
OTC Switch Policies	Vary by country; regulatory agencies like FDA (US), EMA (EU).	Success depends on regulatory approval; impacts sales channels and marketing strategies.
Pricing Regulations	Price controls in certain countries (e.g., Germany, Canada).	Influences profit margins, especially with generics so prevalent.
Patent Litigation and Challenges	Often challenging; generics may file for patent extensions or challenge patents.	Affects market exclusivity timelines and launch strategies in targeted regions.

How Will Market Dynamics Influence Claritin’s Financial Outlook?

Short-Term Outlook (Next 2–5 Years)

• Continued generic penetration around the world will depress brand sales.
• OTC sales in emerging markets will be the primary growth driver.
• Revenue stabilization facilitated by formulary placements and brand loyalty.
• Margins under pressure due to price competition.

Long-Term Outlook (5+ Years)

• Growth potential in emerging markets driven by increasing healthcare access and allergy prevalence.
• Innovation in formulations (e.g., combination therapies, extended-release) may rejuvenate brand relevance.
• Possibility of targeted marketing emphasizing safety profiles and non-drowsiness.

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Key Competitors and Market Shares in the Global Antihistamine Market

Company	Product	Market Share (%)	Segment	Strategic Focus
Johnson & Johnson	Zyrtec (Cetirizine)	10–15	Prescription & OTC	Global growth, innovation
Sanofi	Allegra (Fexofenadine)	5–10	OTC	Market expansion, formulations
Generic Manufacturers	Loratadine Generics	80–90 (US)	OTC	Price competitiveness
Others	Various	Variable	Regional	Niche and regional dominance

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Summary of Market and Financial Trajectory

• Patent expirations and rising generics have significantly curtailed Claritin’s revenue potential in mature markets since the early 2000s.
• Emerging markets offer lucrative growth avenues, especially via OTC channels.
• Formulation innovation and targeted marketing play crucial roles in maintaining relevance amid intense competition.
• The global antihistamine market is projected to grow at a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, driven by increased allergy prevalence worldwide.

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Key Takeaways

• Claritin’s market dominance has diminished due to generics, but it remains a significant brand, especially in OTC settings.
• Future growth hinges on expanding into emerging markets and innovating formulations.
• Competitive pressure requires strategic marketing, legislative navigation, and potential product diversification.
• Strategic partnerships and licensing agreements can extend market reach and revenue streams.
• Stakeholders should monitor regulatory developments and patent landscapes closely to optimize timing for product launches or repositioning.

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FAQs

1. Will Claritin regain market share with a new formulation or formulation upgrade?

While formulation upgrades can incentivize some consumers, they are unlikely to restore previous patent-protected market dominance entirely. Innovation in delivery, combination therapies, or targeting niche indications could, however, provide incremental market share.

2. How might emerging markets influence Claritin’s long-term financial outlook?

Emerging markets present high-growth opportunities due to rising allergy awareness, increasing healthcare access, and regulatory liberalization. Claritin’s success depends on local regulatory approval, pricing strategies, and distribution infrastructure.

3. What are the key regulatory challenges for Claritin’s market expansion?

Obtaining OTC switch approvals in various countries requires meeting safety and efficacy standards. Additionally, patent disputes and local regulatory differences can delay or limit market access.

4. How does the competition from generics impact Claritin’s profitability?

Generics drastically reduce margins, as prices decrease; thus, Claritin’s profitability in mature markets declines with patent expirations. Brand loyalty and marketing are crucial to mitigate this effect.

5. What strategic measures can Claritin’s manufacturers take to sustain revenue?

Focusing on product innovation, expanding into underserved markets, leveraging brand loyalty, and exploring combination products or new delivery systems are potential strategies.

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References

1. Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on health: ARIA 2008 update. Allergy. 2008;63 Suppl 86:8-160.
2. Global Burden of Disease Study 2019. Allergic Conditions Data.
3. MarketWatch. "Antihistamine Market Size, Share & Trends Analysis Report." 2022.
4. U.S. Food and Drug Administration (FDA). “OTC Monographs and Regulations.” 2021.
5. IQVIA. "Global Pharma Market Trends." 2022.

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This comprehensive analysis aims to inform pharmaceutical industry stakeholders, investors, healthcare providers, and policy makers on Claritin’s current market standing, competitive landscape, and future opportunities.