ALLEGRA ALLERGY Drug Patent Profile

Which patents cover Allegra Allergy, and what generic alternatives are available?

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 six 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

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

International Patents for ALLEGRA ALLERGY

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

Country	Patent Number	Title	Estimated Expiration
Norway	308599
Norway	994582
Japan	2002308850	ANTIHISTAMIC PIPERIDINE DERIVATIVE AS FORM II AND ITS PRODUCTION METHOD
South Korea	100387348
South Africa	9503930
Philippines	17023	4-(DIPHENYLMETHYL(ENE))-ALPHA-(SUBSTITUTED-PHENYL)-1-PIPERIDINE-ALKANOL DERIVATIVES

Allegra Allergy: Market Analysis, Investment Scenario, and Financial Trajectory

Last updated: February 3, 2026

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Summary

Allegra Allergy (fexofenadine hydrochloride) is a leading antihistamine used to treat allergic rhinitis and urticaria. Owned primarily by Sanofi and marketed globally, Allegra Allergy demonstrates strong market penetration driven by perennial demand and a robust prescription base. Its revenue stream depends on factors such as patent status, generic competition, market expansion, and regulatory developments. This analysis delineates current market dynamics, forecasts future financial trajectories, and assesses investment opportunities associated with Allegra Allergy.

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1. Market Overview and Dynamics

Parameter	Details
Product Class	Non-sedating antihistamine
Primary Indication	Allergic rhinitis, allergic conjunctivitis, urticaria
Global Market Size (2022)	Approx. USD 6.4 billion (per IQVIA)
Predominant Markets	North America, Europe, Asia-Pacific
Market Growth Rate	CAGR ~3-4% (2022-2027 forecast)
Key Players	Sanofi (original), Mylan (generics), Teva, Sandoz, others

2. Patent and Regulatory Landscape

Timeline	Details
Patent Expiry	Original patents expired in 2014 (U.S. and EU), opening markets to generics
FDA & EMA Approvals	Continued approvals for formulations, dosage strengths
Market Exclusivity	Limited in most regions; generic market share increased post-2014

3. Market Dynamics Influencing Revenue

Factor	Impact
Patent Cliff Effect	Sharp decline in branded sales post-patent expiry in key markets
Generic Competition	Dominates revenue, lowering margins
Brand Loyalty & Prescribing Habits	Moderate; many generics accepted, but branded still retains share in some markets
Market Expansion & Indications	Potential growth via expanded indications, pediatric approvals
Pricing & Reimbursement Policies	Pressure on pricing, especially in cost-sensitive markets
Over-the-Counter (OTC) Sales	Significant portion, especially in U.S. and Europe

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4. Financial Performance & Trajectory

Financial Metric	Historical Data (2020-2022)	Forecast (2023-2027)
Annual Revenue (USD)	USD 250-300 million (Sanofi's branded segment)	USD 150-200 million (post-generic impact)
Market Share (Branded)	~60% pre-2014, now <20% in key markets	Marginalized; branded sales more niche
Earning Margins	Historically high (due to brand premium)	Compressed due to increased generic competition
Growth Rate (2023-2027)	Negative CAGR ~-4% to -6%	Stabilization, minor growth via new markets/indications

5. Investment Scenario Analysis

Key Investment Factors:

Factor	Assessment
Patent Expiry Impact	Sharp decline in revenues; branded segment declines post-2014
Generic Market Penetration	Substantial; generic versions account for >80% of sales in mature markets
New Formulations & Delivery Systems	Potential for growth; e.g., combination therapies or OTC expansion
Market Penetration in Emerging Economies	Opportunity due to rising allergy prevalence and expanding healthcare access
Regulatory & Patent Strategies	Limited scope; companies focus on formulations and new indications

6. Comparative Market Dynamics

Brand vs. Generic	Revenue Contribution & Outlook
Allegra (Brand)	Declining, now niche, mainly in specific markets or formulations
Generics (Fexofenadine)	Main revenue driver; market share >80% in mature markets

Analgesic/Antihistamine Market Segment	Expected Trends
Growth Drivers	Rising allergic conditions, expanding OTC sales
Challenges	Price erosion, regulatory scrutiny

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7. Market Expansion and Diversification Potential

Growth Opportunities	Description
New indications and formulations	E.g., pediatric formulations, combination therapies
Geographical expansion	Asia-Pacific, Latin America, Africa—growing allergy prevalence and healthcare access
Over-the-Counter Transition	Boost sales volume, especially in mature markets
Digital and Telehealth Integration	Drive education, sales, and adherence through online platforms

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8. Comparative Analysis: Allegra Allergy vs. Alternatives

Parameter	Allegra (Fexofenadine)	Cetirizine (Zyrtec)	Loratadine (Claritin)
Onset of Action	1-2 hours	1 hour	1-3 hours
Duration	24 hours	24 hours	24 hours
Sedation Profile	Minimal	Low	Minimal
Pricing	Slight premium in branded form	Lower, generic versions available	Similar to generics
Market Share (2022)	Declining post-patent expiry	Increasing in generics	Stable, high in OTC market

9. Future Outlook & Revenue Projections (2023-2027)

Year	Projected Revenue (USD)	Assumptions
2023	USD 150 million	Continued generic dominance; minor OTC and new markets growth
2024	USD 140 million	Slight decline due to market saturation; possible slight rebound in emerging markets
2025	USD 130 million	Market stabilization; impact of pricing pressures
2026	USD 120 million	Further erosion; potential novel formulations or indications
2027	USD 110 million	Base-case decline trend; limited branded recovery

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10. Strategic Considerations for Investors

Strategy Element	Details
Hold Position	Due to steady OTC demand and niche markets, despite declining branded revenues
Diversify Portfolio	Include other allergy or respiratory drugs with growth potential
Monitor Patent and Regulatory Changes	Key indicator for future revenue stability
Invest in Adjacent Markets	Expansion through OTC and new indications
Evaluate Licensing Opportunities	Licensing newer formulations or combination therapies

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Key Takeaways

• Allegra Allergy's revenues have declined substantially following patent expiry in 2014 due to intense generic competition.
• The current market environment favors generic suppliers, with branded Allegra now a niche, prescription-resistant product.
• Future growth hinges on new formulations, expansion into emerging markets, OTC sales, and potential new indications.
• Investment opportunities should consider declining traditional revenue streams coupled with diversification prospects.
• Strategies around patent management, formulation innovation, and market penetration will be critical for sustained profitability.

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FAQs

Q1: How does Allegra Allergy compare to other antihistamines in terms of efficacy?
A1: Allegra (fexofenadine) offers rapid onset (1-2 hours), 24-hour coverage, and minimal sedation, comparable to cetirizine and loratadine, with slight variations favoring Allegra in specific subpopulations.

Q2: What is the impact of patent expiry on Allegra's revenue?
A2: The patent expiry in 2014 led to a significant revenue decline for brand-specific Allegra, with generics now dominating sales globally.

Q3: Are there any new formulations or indications in development for Allegra?
A3: Current development focuses on OTC formulations, pediatric versions, and possible combination therapies, although no major new indication approvals are recently announced.

Q4: Which markets offer the most growth potential for Allegra-related products?
A4: Emerging markets in Asia-Pacific and Latin America present growth opportunities due to rising allergy prevalence and expanding healthcare infrastructure.

Q5: How does regulatory pressure influence Allegra’s market trajectory?
A5: Regulatory scrutiny over off-label use and patent practices can impact sales, emphasizing the need for innovative formulations and compliant marketing strategies.

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References

[1] IQVIA. "Global Allergy Market Report, 2022".
[2] Sanofi Annual Reports, 2020–2022.
[3] U.S. Food and Drug Administration. "Fexofenadine hydrochloride patent and approval data."
[4] EvaluatePharma. "Pharmaceutical Market Trends, 2022–2027".
[5] World Health Organization. "Global allergy prevalence statistics, 2021".