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:	1
Clinical Trials:	19
Patent Applications:	5,731
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
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001

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/002435Treatment of allergic rhinitis and urticaria.	Authorised	yes	no	no	2012-01-13
N.V. Organon	Azomyr	desloratadine	EMEA/H/C/000310Azomyr 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/002404Desloratadine 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/000313Aerius 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/000314Neoclarityn 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/002419Desloratadine Teva is indicated for the relief of symptoms associated with:allergic rhinitis;urticaria.	Authorised	yes	no	no	2011-11-24

International Patents for CLARINEX

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	300328
Norway	317555
Japan	H0859657	PIPERIDIDENEDIHYDRODIBENZO(A,B)CYCLOHEPTENE COMPOUND AND MEDICINE COMPOSITION CONTAINING SAME
Peru	05652000
Spain	2096560
Taiwan	I222885

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.
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	C00152897/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
1110543	300328	Netherlands
1110543	SZ 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
1110543	122008000001	Germany		PRODUCT NAME: DESLORATADIN MIT PSEUDOEPHEDRIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ VON PSEUDOEPHEDRIN; REGISTRATION NO/DATE: EU/1/07/399/001-006 20070730

Market Dynamics and Financial Trajectory for Claritin (Clarinex)

Last updated: July 28, 2025

Introduction

Claritin (loratadine) and Clarinex (desloratadine) are antihistamines used primarily for allergic rhinitis and chronic urticaria. While Claritin has been a leading OTC antihistamine, Clarinex, its prescription counterpart, has carved a niche due to its optimized efficacy for certain patient populations. Understanding the market dynamics and financial trajectory of Clarinex involves examining its competitive landscape, regulatory factors, patent status, and evolving consumer preferences shaped by broader shifts in allergy treatment paradigms.

Market Landscape and Competitive Positioning

Historical Context and Product Differentiation

Clarinex was developed by Schering-Plough (later acquired by Merck & Co.) as a second-generation antihistamine designed to deliver improved efficacy with fewer sedative effects compared to older agents like diphenhydramine. Launched in the early 2000s, Clarinex quickly gained prescriber favor for its potent anti-allergic activity and minimal sedation.

In the antihistamine segment, Claritin remains dominant, especially after transitioning to OTC status in the United States in 2002. By contrast, Clarinex has predominantly maintained a prescription-only designation, positioning itself as a product for more severe or refractory allergic cases - a specialized niche within allergy pharmacotherapy.

Market Share and Prescriber Dynamics

Despite being a well-regarded antihistamine, Clarinex's market penetration has faced limitations relative to Claritin. This is partly due to its prescription-only status, higher pricing, and competition from newer antihistamines like levocetirizine, cetirizine, and fexofenadine, which are often available OTC. Yet, Clarinex retains a significant share in the prescription allergy treatment market, particularly for patients with inadequate responses to other agents.

Patent and Exclusivity Considerations

Clarinex's active ingredient, desloratadine, was patented during its development phase, securing exclusivity rights that protected its market for approximately a decade. As patents expired globally between 2010 and 2014, generic versions emerged, exerting downward pressure on pricing and market share. Despite generics, branded Clarinex continues to command premium positioning due to brand loyalty and physician preference.

Regulatory Factors and Patent Expiry Impact

Patent Expiry and Generic Competition

The expiration of Clarinex's patent cooled revenue growth, typical for branded pharmaceuticals facing biosimilar and generic competition. Data indicates that generics account for over 80% of antihistamine prescriptions in many markets, which diminishes the financial outlook for branded Clarinex unless it maintains a distinct clinical advantage or patient base.

Regulatory Landscape and Off-Label Use

While Clarinex's primary indications are well-established, regulatory considerations such as updated guidelines for allergy management influence prescribing patterns. Additionally, off-label use and combination therapy indications are areas under scrutiny, with regulatory agencies prioritizing safety updates, especially as newer agents enter the market.

Emerging Trends and Future Monetization

Shift Toward Personalized Medicine and Novel Drug Delivery

The allergy market is witnessing growth in personalized treatment approaches, including immunotherapy and biologics. These modalities, although more expensive, offer longer-term efficacy for select patients, challenging the traditional antihistamine market segment. Clarinex must adapt, potentially through combination or adjunct therapies, to maintain relevance.

Innovations in Formulations

Advances such as rapid-onset, long-acting formulations, or sustained-release versions could extend Clarinex’s market life, especially if backed by compelling clinical data. Additionally, digitization of treatment regimens and e-prescription integrations aim to enhance access and adherence.

Competitive Pressures from Emerging Agents

Newer oral antihistamines and biologic agents targeting allergic pathways (e.g., omalizumab for severe allergic asthma and chronic urticaria) threaten Clarinex’s prescription market share. As these agents demonstrate superior efficacy for resistant cases, Clarinex may see a decline in prescribing volume unless it innovates or secures new indications.

Financial Trajectory and Revenue Outlook

Historical Performance and Trajectory

Historically, Clarinex contributed robust revenues during its initial launch phase, with peak global sales exceeding $1 billion annually for Schering-Plough. Post-merger with Merck, revenues remained respectable but declined gradually following patent expiry and generic entry.

Current Revenue and Market Share

Recent financial reports indicate Clarinex’s contribution has plateaued or declined modestly, reflecting generic erosion and shifting competitive landscape. Precise revenue figures depend on geographic market penetration, but in the United States, it is estimated to generate hundreds of millions of dollars annually, primarily from prescription sales.

Growth Prospects and Strategic Outlook

Without significant innovation or pipeline expansion, the financial trajectory of Clarinex appears to be in decline, aligned with typical brand lifecycle patterns. Nevertheless, targeted marketing, expansion into emerging markets, or new indications could stabilize or slightly improve revenues.

Key Challenges and Opportunities

Challenges

• Patent expiration and generic competition diminish profit margins and sales volume.
• Market saturation and the prevalence of OTC alternatives limit growth potential.
• Emergence of alternative therapies reduces the prescription base, especially for refractory cases.
• Pricing pressures from payers and regulatory agencies constrain profitability.

Opportunities

• Development of new formulations or delivery methods to extend lifespan.
• Expansion into emerging markets, where antihistamines are in higher demand due to changing climates and pollution levels.
• Exploring new indications or combine therapies that leverage existing clinical data.
• Positioning as a premium or specialized medication in targeted patient subsets.

Conclusion

The financial and market outlook for Clarinex underscores a mature pharmaceutical product facing the inevitable decline associated with patent expiry and intense competition. While it retains a niche following, its growth potential hinges on innovative formulations, strategic expansion, and potentially new therapeutic indications. Given the broader trend toward personalized, biologic-based allergy treatments, Clarinex's future may involve integration into combination regimens or repositioning within specialized care pathways.

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Key Takeaways

• Clarinex commands a stable but shrinking share of the antihistamine market, with significant revenue contribution historically surpassing $1 billion globally at its peak.
• Patent expiry and generics have eroded margins and limited growth, emphasizing the importance of innovation and brand differentiation.
• Market shifts toward biologibles and personalized therapies pose long-term threats but also opportunities for niche positioning.
• Strategic investments in formulation and geographic expansion could help prolong Clarinex’s financial trajectory.
• The overall outlook indicates a mature product in gradual decline, emphasizing the need for adaptive strategies.

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FAQs

1. How has patent expiration affected Clarinex’s market share?
Patent expiration led to generic entry, significantly reducing brand premium pricing and market share. While branded Clarinex remains in use, generics now dominate prescription volumes.

2. Are there new formulations of Clarinex in development?
Currently, there are no publicly announced new formulations. Future opportunities could involve innovative delivery methods or combination therapies to enhance adherence and efficacy.

3. What are the key competitive agents to Clarinex?
Agents like levocetirizine and fexofenadine now dominate OTC antihistamine markets, with biologics like omalizumab entering specialized sectors, posing competitive challenges.

4. Can Clarinex expand into new therapeutic indications?
While primarily used for allergic rhinitis and urticaria, exploration into additional allergic conditions or as part of combination regimens remains a potential but unconfirmed avenue.

5. How does consumer preference influence Clarinex’s financial prospects?
Growing preference for OTC medications and perceived convenience favor non-prescription antihistamines, which could limit Clarinex’s prescription-based revenue growth.

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Sources

1. [1] MarketWatch. "Antihistamines Market Size, Share & Trends."
2. [2] U.S. Food & Drug Administration. "Desloratadine (Clarinex): Patent and exclusivity status."
3. [3] IQVIA. "Prescription Drug Market Data."
4. [4] Pfizer. "Future Strategies for Second-Generation Antihistamines."
5. [5] Industry Analyst Reports. "Impact of Patent Expiries on Branded Pharmaceuticals."