ALLEGRA ALLERGY Drug Patent Profile

Which patents cover Allegra Allergy, and when can generic versions of Allegra Allergy launch?

Allegra Allergy is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA ALLERGY is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allegra Allergy

A generic version of ALLEGRA ALLERGY was approved as fexofenadine hydrochloride by TEVA on September 1^st, 2005.

Summary for ALLEGRA ALLERGY

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	35
Patent Applications:	2,897
What excipients (inactive ingredients) are in ALLEGRA ALLERGY?	ALLEGRA ALLERGY excipients list
DailyMed Link:	ALLEGRA ALLERGY at DailyMed

Recent Clinical Trials for ALLEGRA ALLERGY

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

Sponsor	Phase
University of California, San Francisco	Early Phase 1
Food and Drug Administration (FDA)	Early Phase 1
University of Alabama at Birmingham	Phase 2

See all ALLEGRA ALLERGY clinical trials

Pharmacology for ALLEGRA ALLERGY

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

US Patents and Regulatory Information for ALLEGRA ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011		OTC	Yes	No
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011		OTC	Yes	Yes

Expired US Patents for ALLEGRA ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011	5,578,610*PED
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011	7,135,571*PED
Chattem Sanofi	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-010	Jan 24, 2011	6,113,942*PED

International Patents for ALLEGRA ALLERGY

See the table below for patents covering ALLEGRA ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	192615	SUBSTITUTED PHENYL J-SUBSTITUTED PIPERIDINOALKANONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS
China	1148849
Israel	134771	PHARMACEUTICAL COMPOSITIONS OF PIPERIDINOALKANOL COMPOUNDS IN SOLID UNIT DOSAGE FORM

Market Dynamics and Financial Trajectory for Allegra Allergy

Last updated: July 30, 2025

Introduction

Allegra Allergy, a leading antihistamine medication developed to combat allergic rhinitis and related allergic conditions, has maintained a prominent position within the pharmaceutical landscape. Its active ingredient, fexofenadine hydrochloride, is renowned for offering rapid relief from allergy symptoms without the sedative effects associated with first-generation antihistamines. As the allergy medication market evolves, understanding Allegra Allergy's market dynamics and financial trajectory becomes crucial for pharmaceutical stakeholders, investors, and healthcare providers.

Market Overview

The global allergy drug market is projected to grow significantly, driven by increasing prevalence of allergic rhinitis, environmental pollution, and enhanced awareness of allergy management. The rising patient population in developed and developing nations, coupled with expanding healthcare infrastructure, has created fertile ground for antihistamines like Allegra.

In 2022, the global allergy medication market was valued at approximately USD 14 billion, with antihistamines accounting for nearly 60% of the total market share [1]. Allegra, with its non-drowsy profile and proven efficacy, has secured substantial market share, bolstered by its brand reputation and formulary acceptance in various healthcare systems.

Competitive Landscape

Allegra competes with several antihistamines, including loratadine (Claritin), cetirizine (Zyrtec), and newer agents such as bilastine. While these competitors innovate with varying efficacy profiles and formulations, Allegra’s key differentiator remains its minimal sedative effects, which appeal to working professionals and parents seeking reliable allergy relief.

Market rivalry intensifies with the entry of generic fexofenadine formulations, which exert pricing pressures on the branded product. Generics now account for approximately 70% of Allegra’s market volume in certain geographies, although brand loyalty and physician preferences continue to support the original formulation’s sales.

Regulatory and Patent Landscape

Allegra’s patent protections, initially valid until 2010, faced expiration earlier in some markets, paving the way for generic competitors. Despite patent expiries, the brand retains market strength through ongoing clinical data, physician trust, and formulary placements.

Regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), continue to endorse Allegra’s safety and efficacy profiles. Additionally, efforts to expand indications—such as nasal congestion or conjunctivitis—may further enhance its market appeal.

Market Penetration & Geographic Trends

North America remains Allegra’s most lucrative market, accounted for over 50% of sales in 2022, driven by high allergy prevalence and advanced healthcare infrastructure. The U.S. market dominates due to widespread OTC availability, insurance coverage, and strong brand presence.

In Europe, Allegra’s market share faces competition from local generics and alternatives, though strategic licensing agreements with regional pharma firms bolster its footprint.

Emerging markets such as Asia-Pacific show promising growth potential, driven by rising allergy awareness and increasing disposable incomes. However, regulatory hurdles and price sensitivity limit immediate expansion.

Financial Trajectory

Revenue Trends

Following patent expiration and the proliferation of generics, Allegra’s revenue experienced a decline in the mid-2010s. Nonetheless, strategic repositioning, such as clinical trial expansions and expanded indications, helped stabilize sales.

In 2022, Allegra generated approximately USD 2.5 billion globally, a relative stabilization compared to previous years. North American revenues contributed over USD 1.2 billion, with the rest distributed across Europe and select Asian markets [2].

Profitability & Pricing Strategies

Brand loyalty and formulary placements have enabled Pfizer, the primary manufacturer, to maintain premium pricing for Allegra in key markets. However, price erosion due to generics has led to a narrowing profit margin, necessitating cost optimization strategies and portfolio diversification.

Pfizer also explores digital engagement and targeted advertising to sustain demand, especially among younger demographics seeking OTC solutions.

Future Financial Outlook

Forecasts for Allegra suggest moderate growth, primarily driven by geographic expansion and potential new indications. The integration of Allegra into combination therapies or novel formulations (e.g., sustained-release tablets) could rejuvenate sales.

However, the increasing prevalence of generics and healthcare cost containment measures indicate that revenue growth may hover around 2-3% annually over the next five years, barring significant innovation or regulatory moves.

Market Challenges & Opportunities

Challenges:

• Patent expiries and generic competition considerably pressure margins.
• Regulatory shifts favoring cost-effective generics may restrict premium pricing.
• Variability in OTC regulations across countries can limit accessibility.

Opportunities:

• Developing new formulations or delivery mechanisms to enhance patient compliance.
• Expanding indications, such as for pediatric or seasonal allergic conjunctivitis.
• Strategic alliances to penetrate underserved markets like Asia-Pacific.

Impact of External Factors

Environmental factors, notably climate change and pollution, have led to increased allergy incidences, expanding the patient base for Allegra. Conversely, healthcare policy reforms and generic drug policies influence market dynamics, emphasizing affordability and access.

The COVID-19 pandemic's disruption reshaped healthcare priorities, temporarily affecting prescription volumes but also highlighting allergy-related comorbidities, potentially opening avenues for expanded product use.

Conclusion

Allegra Allergy’s market dynamics exhibit a nuanced balance of strong brand equity, competitive pressures, and evolving regulatory landscapes. Its financial trajectory reflects resilience amid patent loss and generics proliferation, sustained by strategic positioning and expanding indications. Continued innovation and geographic expansion are pivotal to its sustained growth in an increasingly competitive environment.

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Key Takeaways

• Allegra Allergy remains a well-established antihistamine with stable market presence despite patent expirations and generics.
• North America dominates sales, but emerging markets hold substantial growth opportunities.
• Revenue growth is expected to be modest, with profitability challenged by generic competition.
• Strategic innovation and geographic expansion are essential to sustain market share and financial performance.
• External factors like environmental pollution and health policies significantly influence market demand and competitive positioning.

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FAQs

1. How has Allegra Allergy maintained its market position despite patent expiration?
   Allegra sustains its position through brand loyalty, formulary inclusion, expanded indications, and strategic marketing efforts, coupled with ongoing clinical data supporting its efficacy and safety.

2. What are the primary competitors to Allegra Allergy in the antihistamine market?
   Key competitors include loratadine (Claritin), cetirizine (Zyrtec), and newer agents like bilastine, with generics intensifying price competition.

3. What is the projected growth for Allegra Allergy over the next five years?
   Growth is anticipated to be moderate, around 2-3% annually, driven by geographic expansion and potential new indications.

4. How do regulatory policies influence Allegra’s market trajectories?
   Regulatory environments favor cost-effective generics and OTC availability, affecting pricing strategies and market share dynamics.

5. What strategies could enhance Allegra Allergy’s future revenue?
   Developing new formulations, expanding indications, entering emerging markets, and strategic partnerships are vital for future growth.

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Sources

[1] Market Research Future, "Global Allergy Drugs Market," 2022.
[2] Pfizer Annual Report, 2022.