CLARINEX Drug Patent Profile

When do Clarinex patents expire, and when can generic versions of Clarinex launch?

Clarinex is a drug marketed by Merck Sharp Dohme, Organon, and Organon Llc. and is included in five NDAs.

The generic ingredient in CLARINEX 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

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	19
Patent Applications:	4,235
Drug Prices:	Drug price information for CLARINEX
What excipients (inactive ingredients) are in CLARINEX?	CLARINEX excipients list
DailyMed Link:	CLARINEX at DailyMed

See drug prices for CLARINEX

See drug sales revenues for CLARINEX

Recent Clinical Trials for CLARINEX

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 clinical trials

Pharmacology for CLARINEX

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for CLARINEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLARINEX	Oral Solution	desloratadine	0.5 mg/mL	021300	1	2008-05-08
CLARINEX	Orally Disintegrating Tablets	desloratadine	2.5 mg and 5 mg	021165	3	2006-06-21

US Patents and Regulatory Information for CLARINEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	AB	RX	Yes	Yes
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005		DISCN	Yes	No
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002		DISCN	Yes	No
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	4,659,716*PED
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	7,405,223*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	5,607,697*PED
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	4,863,931*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	7,214,683*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	6,100,274*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	7,618,649*PED

EU/EMA Drug Approvals for CLARINEX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Actavis Group PTC ehf	Desloratadine Actavis	desloratadine	EMEA/H/C/002435 Treatment of allergic rhinitis and urticaria.	Authorised	yes	no	no	2012-01-13
N.V. Organon	Azomyr	desloratadine	EMEA/H/C/000310 Azomyr is indicated for the relief of symptoms associated with:allergic rhinitis (see section 5.1)urticaria (see section 5.1)	Authorised	no	no	no	2001-01-15
Ratiopharm GmbH	Desloratadine ratiopharm	desloratadine	EMEA/H/C/002404 Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician	Authorised	yes	no	no	2012-01-13
N.V. Organon	Aerius	desloratadine	EMEA/H/C/000313 Aerius is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	no	no	no	2001-01-15
N.V. Organon	Neoclarityn	desloratadine	EMEA/H/C/000314 Neoclarityn is indicated for the relief of symptoms associated with:allergic rhinitisurticaria	Authorised	no	no	no	2001-01-15
Teva B.V	Desloratadine Teva	desloratadine	EMEA/H/C/002419 Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	yes	no	no	2011-11-24
Krka, d.d., Novo mesto	Dasselta	desloratadine	EMEA/H/C/002310 Dasselta is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	yes	no	no	2011-11-28

International Patents for CLARINEX

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	156981	TREATING ALLERGIC AND INFLAMMATORY CONDITIONS
European Patent Office	1251852
Japan	4166948
Netherlands	300042
Hungary	202520	PROCESS FOR PRODUCING 6,11-DIHYDRO-11-(4-PIPERIDINYLIDENE)-5H-BENZO (5,6) CYCLOHEPTA (1,2-B) PYRIDINES AND PHARMACEUTICAL COMPOSITIONS COMPRISING SAME
Cyprus	1109636
Israel	140451	EXTENDED RELEASE ORAL DOSAGE COMPOSITION

Supplementary Protection Certificates for CLARINEX

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.
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	1/2008	Austria		PRODUCT NAME: DESLORATADIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, KOMBINIERT MIT PSEUDOEPHEDRIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER ESTERS; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730
1110543	C 2008 001	Romania		PRODUCT NAME: COMBINATIE DE DESLORATADINA, OPTIONAL SUB FORMA DE SAREACCEPTABILA FARMACEUTIC SI PSEUDOEFEDRINA OPTIONAL SUB FORMA DE SARE SAU ESTER ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/399/001, RO EU/1/07/399/002, RO EU/1/07/399/003, RO EU/1/07/399/004, RO EU/1/07/399/005, RO EU/1/07/399/006; DATE OF NATIONAL AUTHORISATION: 20070730; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/399/001, EU/1/07/399/002, EU/1/07/399/003, EU/1/07/399/004, EU/1/07/399/005, EU/1/07/399/006; DATE OF FIRST AUTHORISATION IN EEA: 20070730
1110543	300328	Netherlands
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	2001C/013	Belgium		PRODUCT NAME: DESLORATADINE; REGISTRTION NO/DATE: EU/1/00/160/010 20010115

Market Dynamics and Financial Trajectory for Claritin

Introduction

Claritin, a well-known antihistamine medication, has been a staple in the allergy relief market for decades. Understanding the market dynamics and financial trajectory of Claritin is crucial for both investors and industry professionals. Here, we delve into the key factors influencing the Claritin market, its current state, and future projections.

Market Size and Forecast

The Claritin market was valued at USD 0.16 billion in 2023 and is projected to reach USD 0.26 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.67% during the forecast period of 2024-2031[1][3].

Global Market Drivers

Several factors drive the growth of the Claritin market:

Product Innovation

Continuous research and development have led to novel formulations, including extended-release variants and combination medicines. These innovations enhance convenience and efficacy, appealing to consumers seeking better allergy relief solutions[1].

Alterations in Lifestyle Factors

Urbanization and increased exposure to allergens such as pollen, dust mites, and pet dander have resulted in a higher demand for allergy treatments. This shift in lifestyle factors contributes significantly to the market growth[1].

Seasonal Demand

Seasonal allergies, particularly during spring and autumn, create periodic spikes in demand for allergy relief medicines like Claritin. This seasonal variability is a key driver of the market[1].

Promotions and Marketing

Effective marketing strategies, including commercials and promotional campaigns, play a crucial role in enhancing brand awareness and stimulating sales. Strong marketing efforts by major players like Bayer AG, Sanofi, and Johnson & Johnson help maintain market momentum[1].

Global Expansion

The expansion of Claritin into new markets and regions increases its consumer base and potential revenue. This global outreach is vital for sustaining growth and capturing new market shares[1].

Market Challenges

Despite the growth drivers, the Claritin market faces several challenges:

Competition from Generic Brands

The presence of generic loratadine products at lower prices can constrain the market share of branded Claritin, impacting profitability. Generic alternatives often attract price-sensitive consumers, which can erode the market share of branded products[1].

Market Saturation

The presence of numerous established antihistamine medicines can lead to market saturation, making it challenging for Claritin to sustain growth. This saturation necessitates innovative marketing and product differentiation strategies[1].

Adverse Effects and Consumer Reservations

Some consumers may be reluctant to use antihistamines due to potential side effects, such as drowsiness, although Claritin is known for being non-drowsy. This consumer skepticism can hinder widespread acceptance[1].

Regulatory Challenges

Changes in legislation or constraints on advertising and marketing can influence the promotion and sale of Claritin. Regulatory hurdles can impact the market's overall stability and growth[1].

Economic Factors

Economic recessions or fluctuations can affect consumer spending on healthcare products, including allergy medications. Economic instability can lead to reduced sales and revenue[1].

Changes in Consumer Preferences

Increasing trends towards natural and holistic health treatments may prompt consumers to seek alternatives to traditional drugs like Claritin. This shift in consumer preferences can pose a challenge to the market[1].

Geographical Segmentation

The Claritin market is segmented geographically into several key regions:

North America

North America, particularly the United States and Canada, has significant market penetration due to strong brand recognition and high prevalence of allergic conditions. Effective marketing strategies and consumer trust in the brand contribute to its dominance in this region[1].

Europe

Europe, with countries like Germany and the UK, shows substantial demand driven by rising pollen levels and increased awareness about allergic rhinitis. The region's mature healthcare market and consumer awareness are key factors[1].

Asia-Pacific

The Asia-Pacific region is emerging as a significant market due to a growing population, urbanization, and higher disposable income. These factors contribute to increased healthcare spending and awareness of allergy-related products[1].

Latin America and Middle East & Africa

Latin America is witnessing a gradual rise in acceptance and demand for allergy medications, driven by growing consumer education on health issues. The Middle East and Africa present unique challenges due to varying healthcare infrastructure but also offer opportunities due to increasing demand for healthcare solutions[1].

Key Players

Major players in the Claritin market include:

• Bayer AG
• Sanofi
• Pfizer
• Johnson & Johnson
• Merck

These companies play a crucial role in driving innovation, marketing, and distribution strategies that influence the market's overall dynamics[1].

Financial Performance

While specific financial data for Claritin alone is not readily available, the performance of its parent companies and the broader market context provide insights:

• Revenue Growth: The overall revenue growth of companies like Organon, which includes revenue from established brands like Claritin, indicates a positive trend. For instance, Organon reported a total revenue of $1.582 billion in the third quarter of 2024, up 4% from the previous year[2].

• Gross Margin: The gross margin for such companies often reflects the profitability of their product portfolios. Organon's gross margin was 58.3% as-reported and 61.7% on a non-GAAP adjusted basis in the third quarter of 2024, which is indicative of the financial health of their product lines[2].

• Research and Development: Continuous investment in research and development is crucial for maintaining market competitiveness. Companies like Organon allocate significant funds to R&D, with budgets ranging from $400 million to $500 million annually[2].

Consumer Trends and Preferences

Consumer trends play a vital role in shaping the market:

• Online Pharmacy Segment: The online pharmacy segment is expected to grow at the fastest CAGR during the forecast period, driven by the large availability and accessibility of diverse product offerings, affordable pricing, and offers. The integration of online pharmacy platforms with telemedicine is also a significant growth driver[4].

• Non-Drowsy Formulations: There is a surge in population awareness regarding allergies and a consumer preference towards non-drowsy formulations like Claritin. This preference is estimated to spur regional revenue growth potential, especially in regions like North America and Europe[4].

Key Takeaways

• The Claritin market is projected to grow at a CAGR of 5.67% from 2024 to 2031.
• Key drivers include product innovation, lifestyle changes, seasonal demand, and effective marketing.
• Challenges such as competition from generic brands, market saturation, and regulatory hurdles need to be addressed.
• Geographical segmentation highlights the importance of North America, Europe, and the emerging Asia-Pacific region.
• Major players like Bayer AG, Sanofi, and Johnson & Johnson drive the market through innovation and marketing.

FAQs

What is the projected market size of Claritin by 2031?

The Claritin market is expected to reach USD 0.26 billion by 2031[1][3].

What is the CAGR of the Claritin market from 2024 to 2031?

The Claritin market is expected to exhibit a CAGR of 5.67% from 2024 to 2031[1][3].

What are the main drivers of the Claritin market?

The main drivers include product innovation, alterations in lifestyle factors, seasonal demand, and effective marketing and promotions[1].

Which regions are key to the Claritin market?

North America, Europe, and the Asia-Pacific region are the key geographical segments driving the Claritin market[1].

How does competition from generic brands affect the Claritin market?

Competition from generic loratadine products can constrain the market share of branded Claritin, impacting profitability due to lower pricing[1].

What role does consumer preference play in the Claritin market?

Consumer preference towards non-drowsy formulations and online pharmacy platforms is a significant growth driver for the Claritin market[4].

Sources

1. Verified Market Research: Claritin Market Size, Share, Growth, Trends & Forecast[1].
2. Organon: Organon Reports Results for the Third Quarter Ended September 30, 2024[2].
3. Business Research Insights: Claritin Market Size, Share Growth and Forecast Till 2032[3].
4. Grand View Research: Loratadine Market Size, Share, Growth, Trends Report, 2030[4].