Desloratadine - Generic Drug Details

What are the generic drug sources for desloratadine and what is the scope of freedom to operate?

Desloratadine is the generic ingredient in five branded drugs marketed by Merck Sharp Dohme, Taro, Organon, Reddys, Belcher Pharms, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Lupin Pharms, Orbion Pharms, Perrigo, Sun Pharm Inds, and Organon Llc, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for desloratadine. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for desloratadine

US Patents:	0
Tradenames:	5
Applicants:	13
NDAs:	17
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	68
Patent Applications:	5,885
Drug Prices:	Drug price trends for desloratadine
What excipients (inactive ingredients) are in desloratadine?	desloratadine excipients list
DailyMed Link:	desloratadine at DailyMed

See drug prices for desloratadine

See drug sales revenues for desloratadine

Recent Clinical Trials for desloratadine

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
University of Victoria	N/A
J. Uriach and Company	Phase 1

See all desloratadine clinical trials

Generic filers with tentative approvals for DESLORATADINE

Applicant	Application No.	Strength	Dosage Form
		5MG	TABLET; ORAL
		5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for desloratadine

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

Anatomical Therapeutic Chemical (ATC) Classes for desloratadine

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

Paragraph IV (Patent) Challenges for DESLORATADINE

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 desloratadine

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	desloratadine	TABLET;ORAL	078365-001	Mar 8, 2011	AB	RX	No	No
Reddys	DESLORATADINE	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	078367-002	Jul 12, 2010		RX	No	Yes

Expired US Patents for desloratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	5,607,697*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	7,214,684*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	4,804,666*PED

EU/EMA Drug Approvals for desloratadine

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

Desloratadine Market Analysis and Financial Projection

Desloratadine Market Dynamics and Financial Trajectory

Introduction to Desloratadine

Desloratadine, a second-generation antihistamine, is a pivotal medication in the global allergy treatment landscape. It is used to relieve symptoms of allergies such as sneezing, runny nose, itchy eyes, and chronic urticaria (hives), without causing drowsiness, making it a preferred choice for managing chronic allergies[1][3][4].

Market Size and Projection

The global desloratadine market has been experiencing significant growth. As of 2023, the market was valued at approximately USD 1.2 billion 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[1].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

The global rise in allergic diseases, particularly allergic rhinitis which affects approximately 20% of the global population, is a major driver of the desloratadine market. Environmental factors, lifestyle changes, and increased pollution contribute to this surge in allergy cases[1][3].

Innovations in Formulations

Recent advancements in desloratadine formulations, such as extended-release tablets, oral dissolvable tablets, and liquid forms, are enhancing its effectiveness and patient compliance. These innovations allow for more convenient dosing schedules and improved therapeutic outcomes, which in turn drive market growth[1].

Digital Health Integration

The integration of digital health technologies, including mobile health applications and wearable devices, is revolutionizing the desloratadine market. These tools track allergy symptoms and medication adherence, providing real-time data and personalized recommendations, which empower patients to manage their allergies more effectively[1].

Personalized Medicine

Advances in genetic research and biomarker identification are leading to tailored treatments based on individual patient profiles. This trend towards personalized medicine enhances the efficacy of desloratadine and minimizes potential side effects, catering to diverse patient needs and driving market growth[1].

Regulatory Environment

Regulatory bodies worldwide are implementing stricter guidelines for allergy medications, promoting the development of safer and more effective treatments. These regulations encourage pharmaceutical companies to invest in research and development, leading to innovative desloratadine formulations and improved market offerings[1].

Market Segmentation

The global desloratadine market is segmented based on product, application, and geography.

By Product

The market is classified into injection and freeze-dried powder forms. The introduction of new product forms such as oral dissolvable tablets and liquid forms is expanding the product segment[4].

By Application

The market is segmented into hospital use, clinic use, and other applications. The widespread use of desloratadine in various healthcare settings drives demand across these segments[4].

By Geography

The market is classified into North America, Europe, Asia Pacific, and the rest of the world. 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[1][4].

Competitive Landscape

The desloratadine market is competitive, with several key players including Pfizer, Teva, Wante Pharmaceutical, Novartis India Limited, Mylan, Sepracor, Sandoz, Apollo Pharmaceuticals, GSK, Mayne Pharma Inc, Abhilasha Pharma Pvt, Abbott, Takeda, and Schering-Plough. These companies are involved in strategic partnerships, mergers, and acquisitions to advance desloratadine research and development and expand their market presence[4].

Financial Opportunities

Investing in the desloratadine market presents significant economic opportunities. The rising demand for effective allergy treatments, ongoing research and development, and expanding global reach are expected to yield substantial returns on investment. The market's growth is driven by continuous innovation and the increasing prevalence of allergic conditions[1][4].

Strategic Partnerships and Mergers

Pharmaceutical companies are forming strategic partnerships to advance desloratadine research and development. Collaborations between drug manufacturers and research institutions focus on optimizing desloratadine formulations and exploring new therapeutic applications. Mergers and acquisitions are also common as companies seek to expand their portfolios and enhance their market presence[1].

Future Outlook

The future of the desloratadine market looks promising, with ongoing research and development efforts enhancing treatment options. The shift towards personalized medicine and digital health integration is expected to drive further growth and create new investment opportunities. As the market continues to grow, embracing these trends will be crucial for stakeholders aiming to capitalize on the evolving landscape of allergy management[1].

Key Takeaways

• Market Growth: The desloratadine market is projected to grow at a CAGR of 7.2% through 2030, driven by increasing allergy prevalence and innovations in formulations.
• Innovations: Advances in formulations, digital health integration, and personalized medicine are reshaping allergy treatments.
• Regulatory Environment: Stricter guidelines promote safer and more effective treatments.
• Market Segmentation: The market is segmented by product, application, and geography, with emerging markets in Asia-Pacific and Latin America showing significant growth.
• Competitive Landscape: Key players are involved in strategic partnerships, mergers, and acquisitions to advance research and development.
• Financial Opportunities: Investing in the desloratadine market offers significant economic opportunities due to rising demand and ongoing innovation.

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)[1].

2. How does desloratadine differ from first-generation antihistamines?

Desloratadine is a non-sedative medication, unlike first-generation antihistamines, which can cause drowsiness[1].

3. What are the key drivers of the desloratadine market growth?

Key drivers include the increasing prevalence of allergies, innovations in formulations, digital health integration, and the trend towards personalized medicine[1][3][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[1][4].

5. What are the financial opportunities in the desloratadine market?

Investing in the desloratadine market offers significant economic opportunities due to rising demand, ongoing research and development, and expanding global reach[1][4].

Sources

1. Market Research Intellect: Desloratadine Market Dynamics - How Innovations and Expanding Demand Are Reshaping Allergy Treatments[1].
2. MarkWide Research: Desloratadine Market 2024-2032 | Size, Share, Growth[2].
3. IMARC Group: Desloratadine (Clarinex) Manufacturing Plant Project Report 2024[3].
4. Verified Market Research: Desloratadine Sales Market Size And Forecast[4].
5. DataIntelo: Desloratadine Market Report | Global Forecast From 2023 To 2032[5].