Desloratadine; pseudoephedrine sulfate - Generic Drug Details

What are the generic sources for desloratadine; pseudoephedrine sulfate and what is the scope of patent protection?

Desloratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Organon, Organon Llc, and Dr Reddys Labs Ltd, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for desloratadine; pseudoephedrine sulfate

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	desloratadine; pseudoephedrine sulfate at DailyMed

Recent Clinical Trials for desloratadine; pseudoephedrine sulfate

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1

See all desloratadine; pseudoephedrine sulfate clinical trials

Pharmacology for desloratadine; pseudoephedrine sulfate

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

Anatomical Therapeutic Chemical (ATC) Classes for desloratadine; pseudoephedrine sulfate

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for desloratadine; pseudoephedrine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005		DISCN	Yes	No
Dr Reddys Labs Ltd	DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	078366-001	Apr 26, 2011		RX	No	Yes
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 desloratadine; pseudoephedrine sulfate

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
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006
Organon	CLARINEX D 24 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021605-001	Mar 3, 2005

Desloratadine; pseudoephedrine sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Desloratadine and Pseudoephedrine Sulfate

Introduction

Desloratadine and pseudoephedrine sulfate are key components in the treatment of allergic rhinitis and other allergy-related symptoms. Understanding the market dynamics and financial trajectory of these drugs is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global desloratadine market was valued at approximately USD 1.2 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030. This growth is driven by increasing allergy prevalence, heightened awareness about allergic conditions, and advancements in pharmaceutical formulations[4].

Key Drivers of Growth

Increasing Allergy Prevalence

The rising number of patients suffering from allergic rhinitis and nasal congestion globally is a major factor driving the growth of the desloratadine market. Allergic conditions are becoming more prevalent, leading to an increased demand for effective treatments[1][4].

Advancements in Formulations

Recent innovations in desloratadine formulations, such as extended-release tablets, oral dissolvable tablets, and liquid forms, are enhancing the drug's effectiveness and patient compliance. These advancements allow for more convenient dosing schedules and improved therapeutic outcomes[4].

Digital Health Integration

The integration of digital health technologies, including mobile health applications and wearable devices, is revolutionizing the desloratadine market. These tools provide real-time data and personalized recommendations, empowering patients to manage their allergies more effectively[4].

Market Segmentation

Product Type

The desloratadine market is segmented by product type into injection and freeze-dried powder. However, the most common form of desloratadine is oral tablets, which are preferred for their ease of administration and patient compliance[1].

End-Use

The market is also segmented by end-use into hospitals, clinics, and others. Hospitals and clinics are the primary end-users, given the need for professional medical supervision in the administration of these medications[1].

Combination Therapies

Desloratadine and Pseudoephedrine Sulfate

The combination of desloratadine and pseudoephedrine sulfate is gaining popularity due to its synergistic effects. This combination therapy, often referred to as DL/PSE, provides comprehensive relief from multiple allergy symptoms, including nasal congestion, which is a prominent symptom in seasonal allergic rhinitis[5].

Efficacy and Safety

Studies have shown that the combination of desloratadine and pseudoephedrine sulfate is more effective in reducing symptoms of seasonal allergic rhinitis compared to monotherapy with either component. This combination significantly reduces the total symptom score (TSS) and nasal congestion score, making it a valuable treatment option[5].

Competitive Landscape

The desloratadine market is highly competitive, with several major pharmaceutical companies involved. Key players include Pfizer, Teva, Novartis, Mylan, Sumitomo Dainippon, Takeda, GlaxoSmithKline, Mayne Pharma, Abbott, and Schering-Plough. These companies are engaged in various strategies such as mergers and acquisitions, joint ventures, collaborations, and partnerships to enhance their market presence and product portfolios[1].

Financial Trajectory

Revenue Growth

The desloratadine market is expected to see significant revenue growth driven by the increasing demand for allergy treatments. The global pharmaceutical market, within which desloratadine operates, was estimated at USD 1,482.0 billion in 2022 and is expected to grow at a CAGR of 6.12% from 2023 to 2030[3].

Investment Opportunities

Investing in the desloratadine market presents significant economic opportunities due to the rising allergy prevalence and increasing demand for effective treatments. Strategic partnerships, new product launches, and market expansion efforts are promising prospects for investors[4].

Emerging Markets

Emerging markets in Asia-Pacific and Latin America are becoming significant contributors to the desloratadine market. Economic growth, increased healthcare access, and rising awareness of allergy treatments in these regions are driving market expansion. Pharmaceutical companies are focusing on these markets to tap into the growing demand for desloratadine[4].

Regulatory and Approval Landscape

The approval of new desloratadine formulations and combination therapies is crucial for market growth. For instance, the FDA's approval of generic drugs and the increasing number of ANDA approvals are contributing to the expansion of the desloratadine market[3].

Patient Compliance and Adherence

Patient compliance and adherence to treatment regimens are critical factors in the success of desloratadine and pseudoephedrine sulfate. Studies have shown that combination therapies like DL/PSE improve patient satisfaction and adherence, leading to better health outcomes[5].

Conclusion

The market for desloratadine and pseudoephedrine sulfate is dynamic and growing, driven by increasing allergy prevalence, advancements in formulations, and digital health integration. The combination therapy of desloratadine and pseudoephedrine sulfate offers significant benefits in treating seasonal allergic rhinitis, making it a valuable treatment option. As the market continues to expand, especially in emerging regions, it presents substantial investment opportunities and growth potential for pharmaceutical companies.

Key Takeaways

• The global desloratadine market is projected to grow at a CAGR of 7.2% through 2030.
• Advancements in formulations and digital health integration are key drivers of growth.
• Combination therapies like DL/PSE offer synergistic effects and improved patient compliance.
• Emerging markets in Asia-Pacific and Latin America are significant contributors to market growth.
• Patient compliance and adherence are critical for the success of desloratadine and pseudoephedrine sulfate treatments.

FAQs

1. What is desloratadine used for? Desloratadine is an antihistamine used to relieve symptoms of allergies, such as sneezing, runny nose, itchy eyes, and chronic urticaria (hives)[4].

2. How does the combination of desloratadine and pseudoephedrine sulfate work? The combination of desloratadine and pseudoephedrine sulfate provides comprehensive relief from multiple allergy symptoms, including nasal congestion, by combining the antihistamine and decongestant effects[5].

3. What are the key drivers of growth in the desloratadine market? Key drivers include increasing allergy prevalence, advancements in pharmaceutical formulations, and digital health integration[4].

4. Which regions are emerging as significant contributors to the desloratadine market? Emerging markets in Asia-Pacific and Latin America are becoming significant contributors due to economic growth, increased healthcare access, and rising awareness of allergy treatments[4].

5. How does the combination therapy of desloratadine and pseudoephedrine sulfate impact patient compliance? The combination therapy improves patient satisfaction and adherence to treatment regimens, leading to better health outcomes[5].

Sources

1. BioSpace - Desloratadine Market Size 2022-2028[1]
2. FDA - CLARINEX-D® 24 HOUR 1 (desloratadine 5 mg and pseudoephedrine sulfate)[2]
3. Grand View Research - Pharmaceutical Market Size, Share & Trends Report, 2030[3]
4. Market Research Intellect - Desloratadine Market Size And Projection[4]
5. JIACI - Efficacy and Safety of Desloratadine/Pseudoephedrine[5]