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, Ajenat 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:	121
Clinical Trials:	72
Patent Applications:	7,964
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
Montefiore Medical Center	PHASE2
Laboratorios Silanes S.A. de C.V.	PHASE3
Medical University of Silesia	NA

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
Merck Sharp Dohme	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004		DISCN	Yes	No
Chartwell Rx	DESLORATADINE	desloratadine	TABLET;ORAL	078364-001	Dec 3, 2010		DISCN	No	No
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313-001	Feb 1, 2006		RX	Yes	Yes
Lupin Pharms	DESLORATADINE	desloratadine	TABLET;ORAL	078352-001	Oct 25, 2010	AB	RX	No	No
Perrigo	DESLORATADINE	desloratadine	TABLET;ORAL	078361-001	Dec 22, 2011		DISCN	No	No

Expired US Patents for desloratadine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	5,607,697*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	5,178,878*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-002	Jul 14, 2005	5,178,878*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	7,211,582*PED
Organon	CLARINEX	desloratadine	TABLET, ORALLY DISINTEGRATING;ORAL	021312-001	Jun 26, 2002	4,804,666*PED
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165-001	Dec 21, 2001	7,405,223*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/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

Market Dynamics and Financial Trajectory for Desloratadine

Last updated: July 28, 2025

---

Introduction

Desloratadine, a selective peripheral inverse agonist of peripheral H₁ receptors, is a second-generation antihistamine predominantly prescribed for allergic rhinitis and chronic idiopathic urticaria. Since its initial approval in the early 2000s, desloratadine has established itself as a leading antihistaminic agent globally, owing to its favorable safety profile and minimal sedative effects. This article examines the evolving market dynamics and financial outlook for desloratadine, analyzing key drivers, challenges, and emerging opportunities influencing its trajectory.

---

Global Market Overview

The global antihistamine market, valued at approximately USD 3.4 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030, driven primarily by increasing prevalence of allergic disorders and expanding healthcare access in emerging markets [1]. Desloratadine's dominant position within the second-generation antihistamines has contributed significantly to this growth.

Regional markets display divergent dynamics. North America, with its high awareness and access to healthcare, accounts for roughly 45% of the global desloratadine market. Europe follows, supported by an aging population and rising allergy incidence. Asia-Pacific has shown accelerated growth—at a CAGR of approximately 5.8%—due to increased urbanization, pollution-related allergies, and expanding healthcare infrastructure [2].

---

Key Market Drivers

1. Rising Prevalence of Allergic Disorders

The global allergy burden continues to expand, with reports indicating that approximately 20-30% of the population suffers from allergic rhinitis and urticaria [3]. Increased diagnosis rates and broader awareness bolster demand for effective antihistamines like desloratadine.

2. Efficacy and Safety Profile

Desloratadine’s minimal sedative effects, once-daily dosing, and safety in pediatric and elderly populations underpin its sustained popularity. Its over-the-counter (OTC) availability in several markets further amplifies consumer access.

3. Patent Expiry and Market Entry

Generic pharmaceutical companies have introduced cost-effective desloratadine formulations, boosting accessibility and volume sales. The expiration of patents in key markets (e.g., the US in 2019) facilitated proliferation of generics, intensifying competitive dynamics.

4. Strategic Alliances and Market Expansion

Pharmaceutical firms pursue licensing agreements and regional expansion to capitalize on emerging markets. For instance, local formulations tailored to regional preferences have contributed to increased sales volumes.

---

Challengers and Market Constraints

1. Pricing Pressures

Generic proliferation exerts downward pressure on prices, impacting profit margins. The commoditization of desloratadine constrains revenue growth unless offset by volume increases.

2. Regulatory and Patent Challenges

While patent expiries foster generic competition, ongoing patent disputes and regulatory hurdles can delay new product introductions, affecting revenue timelines.

3. Market Saturation in Developed Regions

High penetration rates in North America and Europe create limited room for growth, prompting companies to target emerging markets or diversify product portfolios.

4. Emerging Competitors

Newer antihistamines or combination therapies, with improved efficacy or expanded indications, threaten to displace desloratadine in certain patient segments.

---

Financial Trajectory and Future Outlook

The financial prospects of desloratadine hinge on multiple factors:

• Market Penetration and Growth:
  In developed markets, desloratadine’s sales are stabilizing due to saturation. However, robust growth persists in Asia-Pacific and Latin America, where healthcare penetration is still increasing and allergy prevalence is rising [4].

• Margins and Pricing Strategy:
  The commoditization driven by generics has compressed profit margins. Yet, economies of scale, optimized supply chains, and regional tailored formulations can sustain favorable margins.

• Research and Development:
  Incremental innovations, such as combination drugs or new delivery routes, may create ancillary revenue streams. However, significant R&D investment risk limits the likelihood of label extensions unless new indications are discovered.

• Market Entry and Expansion Strategies:
  Companies adopting aggressive regional expansion and engaging in strategic licensing are poised for increased revenue, particularly in underserved markets with rising allergy incidence.

• Impact of COVID-19:
  The pandemic influenced allergy and respiratory condition management, temporarily increasing demand for antihistamines like desloratadine. Post-pandemic recovery appears to reinforce sales momentum as healthcare systems normalize.

Projected Revenue Outlook

Analysts project the global desloratadine market to grow at a moderate CAGR of approximately 3.5-4.0% over the next five years, driven by emerging markets and increased OTC sales. The market value may approach USD 4.2 billion by 2028, with North America and Europe contributing over 60% of revenues, albeit with marginal growth rates. Notably, the Asia-Pacific segment is expected to register the fastest CAGR, buoyed by demographic and infrastructural factors.

---

Competitive Landscape

Key players include Sanofi, Teva Pharmaceuticals, Mylan (now part of Viatris), and Amneal Pharmaceuticals—each leveraging patent expirations to expand generic offerings. Sanofi’s initial development and commercialization of desloratadine as a branded product established early dominance. Currently, the generic segment comprises over 85% of sales volume due to price sensitivity and widespread availability.

Emerging Opportunities

• Digital Health and Telepharmacy:
  Integration into online healthcare platforms facilitates patient access and adherence, especially in remote regions.

• Combination Therapies:
  Developing multi-active formulations combining desloratadine with decongestants or corticosteroids can address broader clinical needs and open new revenue streams.

• Personalized Medicine:
  Genetic profiling to identify responsive subpopulations may refine prescribing practices and improve market segmentation.

• Regulatory Advances:
  Streamlining approval processes for biosimilars or novel formulations could accelerate market penetration.

---

Conclusion

Desloratadine’s market remains resilient, supported by its efficacy, safety, and widespread adoption. However, increasing generic competition, pricing pressures, and market saturation in developed regions temper growth prospects. The most promising opportunities lie in emerging markets, innovative formulations, and digital health integration. To capitalize on these dynamics, pharmaceutical companies must adopt region-specific strategies, invest in incremental innovation, and monitor regulatory shifts closely.

---

Key Takeaways

• The global desloratadine market is expected to grow steadily, primarily driven by emerging markets and OTC sales.
• Patent expiries have catalyzed intense generic competition, constraining margins but expanding accessibility.
• Market saturation in developed regions requires strategic diversification and innovation to sustain growth.
• Emerging opportunities include combination therapies, digital health integration, and regional expansion.
• Long-term success will depend on balancing cost optimization with innovative approaches to address evolving consumer and regulatory landscapes.

---

FAQs

1. What factors most significantly influence desloratadine's market growth?
Prevalence of allergic disorders, patent expirations, generic competition, regulatory policies, and emerging market expansions are primary drivers.

2. How do patent expirations affect desloratadine’s market dynamics?
Patent expiries enable generic manufacturers to introduce cost-effective alternatives, increasing market competition, reducing prices, and impacting brand revenues.

3. Are there opportunities for desloratadine in treating new indications?
Currently, desloratadine’s approvals focus on allergic rhinitis and urticaria. Research into new indications is limited; most growth strategies focus on expanding existing markets rather than novel uses.

4. How has COVID-19 influenced the desloratadine market?
The pandemic temporarily increased demand due to respiratory and allergy-related symptoms, with post-pandemic recovery expected to stabilize and potentially boost sales further.

5. What strategies can pharmaceutical companies adopt to sustain desloratadine revenues?
Strategies include geographic expansion, developing combination therapies, cost optimization of manufacturing, digital health integration, and pursuing incremental innovation.

---

References

[1] MarketWatch. Antihistamine Drugs Market Size, Share & Industry Analysis, 2023-2030.
[2] Research and Markets. Geographic Insights into the Antihistamines Market.
[3] World Allergy Organization. Global Allergy Report 2022.
[4] IMS Health. Emerging Markets in Pharmaceutical Sales, 2022.

---