CLARINEX-D 12 HOUR Drug Patent Profile

When do Clarinex-d 12 Hour patents expire, and when can generic versions of Clarinex-d 12 Hour launch?

Clarinex-d 12 Hour is a drug marketed by Organon Llc and is included in one NDA.

The generic ingredient in CLARINEX-D 12 HOUR 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-D 12 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	16
What excipients (inactive ingredients) are in CLARINEX-D 12 HOUR?	CLARINEX-D 12 HOUR excipients list
DailyMed Link:	CLARINEX-D 12 HOUR at DailyMed

Recent Clinical Trials for CLARINEX-D 12 HOUR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
J. Uriach and Company	Phase 1
Derm Research, PLLC	Phase 4
UCB Pharma	Phase 4

See all CLARINEX-D 12 HOUR clinical trials

Pharmacology for CLARINEX-D 12 HOUR

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for CLARINEX-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes

Expired US Patents for CLARINEX-D 12 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	8,187,630
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	4,659,716*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,618,649*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,214,683*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	7,214,684*PED
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006	6,709,676

International Patents for CLARINEX-D 12 HOUR

See the table below for patents covering CLARINEX-D 12 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0859657	PIPERIDIDENEDIHYDRODIBENZO(A,B)CYCLOHEPTENE COMPOUND AND MEDICINE COMPOSITION CONTAINING SAME
European Patent Office	2100600
Canada	2208836	PROCEDES ET COMPOSITION DE TRAITEMENT DE LA RHINITE ALLERGIQUE ET D'AUTRES TROUBLES AU MOYEN DE DESCARBOETHOXYLORATADINE (METHODS AND COMPOSITIONS FOR TREATING ALLERGIC RHINITIS AND OTHER DISORDERS USING DESCARBOETHOXYLORATADINE)
Slovakia	287105
Australia	570306
Japan	2001206846	SUSTAINED-RELEASE ORAL ADMINISTRATION COMPOSITION

Supplementary Protection Certificates for CLARINEX-D 12 HOUR

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 CLARINEX-D 12 HOUR

Last updated: July 27, 2025

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Introduction

CLARINEX-D 12 HOUR, a combination antihistamine medication designed to manage allergy symptoms, occupies a unique niche in the multibillion-dollar allergy therapeutics sector. With its distinctive formulation that combines loratadine, a non-sedating antihistamine, and pseudoephedrine, a decongestant, CLARINEX-D 12 HOUR capitalizes on the persistent demand for effective, long-acting allergy relief. This report analyzes the current market dynamics influencing the drug's trajectory and projects future financial performance within the evolving pharmaceutical landscape.

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Market Landscape

Global Allergy Therapeutics Market

The allergy therapeutics market is projected to reach approximately US$18 billion by 2026, driven by rising prevalence of allergic rhinitis, allergic conjunctivitis, and other hypersensitivity conditions [1]. North America dominates the segment, owing to high disease awareness and established healthcare infrastructure, while Asia-Pacific exhibits rapid growth potential due to increasing urbanization and environmental pollutants.

Key Competitors and Market Share

CLARINEX-D 12 HOUR faces competitive pressure from both branded and generic products within the antihistamine segment. Major competitors include Claritin-D, Zyrtec-D, and generic loratadine-based formulations with decongestants. Claritin-D, a direct competitor often considered the primary alternative, retains a significant market share owing to its early entry and brand strength. However, patent expirations and regulatory reforms have introduced a wave of generic alternatives, gradually eroding brand loyalty and compressing profit margins.

Regulatory and Pharmacovigilance Factors

Regulatory bodies, notably the U.S. Food and Drug Administration (FDA), impose strict guidelines on combination products containing pseudoephedrine due to its potential for misuse. As a result, manufacturing and sales are subject to federal controls like the Combat Methamphetamine Epidemic Act, influencing distribution channels and marketing strategies [2]. Increasing scrutiny toward pseudoephedrine-containing drugs could impact CLARINEX-D 12 HOUR's market access and profitability.

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Market Dynamics Influencing Financial Trajectory

1. Demographic and Epidemiological Trends

The incidence of allergic rhinitis and related conditions is trending upward globally, attributed primarily to environmental factors like pollution, climate change, and urban living. According to the World Allergy Organization, nearly 30-40% of the global population suffers from allergic rhinitis, with prevalence rates rising steadily [3]. This demographic demand sustains a robust market for long-acting combination antihistamines, including CLARINEX-D 12 HOUR.

2. Consumer Preferences and Prescribing Trends

There is a shift towards non-sedating, long-acting antihistamines due to increased consumer awareness about side effects associated with first-generation antihistamines. CLARINEX-D, with a 12-hour efficacy profile, aligns with these preferences, enabling it to maintain therapeutic relevance. However, generic formulations encroach on branded product market share as cost-sensitive consumers favor lower-priced options, pressuring branded drug revenues [4].

3. Healthcare Policy and Reimbursement Landscape

Reimbursement policies significantly influence drug sales trajectories. Health insurers and government payers favor generic alternatives due to cost savings, which impacts branded medication sales. Any policy amendments favoring biosimilar or generic competition would further decelerate revenue growth for CLARINEX-D 12 HOUR.

4. Patent Status and Market Exclusivity

Approaching patent expiration phases threaten exclusive market positioning. The patent for Claritin-D (the primary branded alternative) expired in 2018, and similar formulations now face generic entry. CLARINEX-D 12 HOUR, depending on patent status, may experience similar vulnerabilities, necessitating strategic actions to extend exclusivity or innovate.

5. Supply Chain and Manufacturing Considerations

Supply chain resilience, especially amid disruptions like the COVID-19 pandemic, influences product availability and profitability. The production of pseudoephedrine is heavily regulated, adding logistical and compliance challenges. Investment into reliable sourcing and manufacturing efficiency becomes crucial to sustain financial performance.

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Financial Trajectory Outlook

Revenue Trends

Historically, CLARINEX-D 12 HOUR has generated steady revenues within the antihistamine segment, driven by its long-acting profile and brand recognition. However, with increasing generic competition, revenues are likely to plateau and possibly decline unless mitigated by strategic initiatives.

Profit Margins

Brand loyalty and differentiated formulations support higher margins initially. Over time, erosion due to generics, regulatory costs, and distribution limitations constrict profitability. Companies may need to invest in marketing, lifecycle management, or formulation innovations to preserve margins.

Growth Opportunities

• Line Extensions and New Formulations: Developing allergen-specific or pediatric formulations can open new market segments.
• Geographic Expansion: Penetrating emerging markets where allergy prevalence is rising can foster growth.
• Strategic Partnerships: Collaborations with generics manufacturers or biosimilar developers can diversify revenue channels.
• Regulatory Approvals: Obtaining approval for novel combinations or delivery systems can enhance product differentiation.

Potential Risks

• Regulatory Restrictions: Tightening pseudoephedrine controls could limit sales channels.
• Market Saturation: Widespread availability of generics undermines premium pricing.
• Patent Challenges: Legal disputes may accelerate patent cliffs.
• Environmental and Social Factors: Pollution and climate change will continue to influence allergy prevalence, but supply chain disruptions may impact manufacturing.

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Regulatory and Commercial Strategies

To navigate market dynamics effectively, companies should consider:

• Patent Management and Lifecycle Extension: Patent strategies, including formulations and delivery modes, can prolong exclusivity.
• Cost Optimization: Streamlining manufacturing and distribution to maintain margins amid price pressures.
• Market Diversification: Expanding into pediatric, geriatric, and emerging markets to offset saturation.
• Regulatory Engagement: Proactively managing pseudoephedrine regulations and securing necessary licenses.
• Innovation Investment: Developing novel formulations, combination therapies, or delivery systems to differentiate offerings.

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Conclusion

The financial trajectory of CLARINEX-D 12 HOUR is shaped by complex market dynamics, including demographic trends, regulatory environments, competitive pressures, and innovation opportunities. While current revenues benefit from strong brand recognition and product efficacy, impending patent expirations and increasing competition necessitate strategic repositioning. Companies that effectively leverage regulatory tactics, geographical expansion, and formulation innovation will better sustain profitability and market share in this evolving landscape.

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Key Takeaways

• The allergy therapeutics sector remains robust but highly competitive, with major players facing patent expiration challenges.
• CLARINEX-D 12 HOUR benefits from its long-acting formulation and favorable consumer trends toward non-sedating antihistamines.
• Regulatory restrictions on pseudoephedrine significantly influence distribution and sales, presenting both challenges and opportunities for differentiation.
• Market growth depends on geographic expansion, product innovation, and strategic patent management.
• Cost efficiencies and lifecycle extension initiatives are essential to sustain profitability amid rising generic competition.

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FAQs

1. What factors could accelerate the generic entry for CLARINEX-D 12 HOUR?
Patent expirations, regulatory approvals for generics, and legal challenges on formulation patents can facilitate earlier market entry for generics, pressuring branded sales.

2. How do regulatory restrictions on pseudoephedrine impact CLARINEX-D’s market reach?
Stringent controls limit distribution channels, increase compliance costs, and may restrict sales in certain markets, reducing revenue flexibility.

3. What growth strategies can pharmaceutical companies adopt for CLARINEX-D 12 HOUR?
Expanding into emerging markets, developing new formulations, leveraging brand loyalty, and pursuing patent extensions are key strategies.

4. How does consumer preference influence the product’s financial performance?
Shifts toward non-sedating, long-acting antihistamines sustain demand, but price sensitivity favors generics, which can erode margins of branded formulations like CLARINEX-D.

5. What role does environmental change play in the future demand for allergy medications?
Increased pollution and climate change are likely to elevate allergy prevalence, fueling sustained or growing demand for effective therapeutics such as CLARINEX-D.

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Sources

[1] MarketResearch.com. (2022). Global Allergy Therapeutics Market Outlook.
[2] FDA Guidelines. (2021). Regulations on Pseudoephedrine sales.
[3] World Allergy Organization. (2022). Global allergy prevalence statistics.
[4] Industry Reports. (2022). Trends in Antihistamine Prescriptions and Market Shares.