ALLEGRA HIVES Drug Patent Profile

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

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

The generic ingredient in ALLEGRA HIVES 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 Hives

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

Summary for ALLEGRA HIVES

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ALLEGRA HIVES

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 HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-008	Jan 24, 2011		DISCN	Yes	No
Chattem Sanofi	ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-009	Jan 24, 2011		OTC	Yes	Yes

International Patents for ALLEGRA HIVES

See the table below for patents covering ALLEGRA HIVES 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

Allegra Hives: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Allegra Hives, a novel pharmaceutical treatment targeting allergic hives, presents a unique investment opportunity within the specialty allergy therapeutics sector. As of 2023, the drug’s market is evolving due to increasing prevalence of allergic conditions, rising awareness, and an unmet need for rapid, long-lasting symptom relief. This analysis evaluates the current market landscape, projected growth, competitive positioning, regulatory considerations, and potential financial trajectory, providing a comprehensive basis for investment decisions.

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Market Overview

Industry Context and Market Size

The global allergy immunology market was valued at approximately USD 14.8 billion in 2022, with expected compound annual growth rate (CAGR) of 8-10% over the next five years. The segment focusing on chronic hives (also called chronic spontaneous urticaria, CSU) expects to expand significantly due to:

• Prevalence: Approximately 1-3% of the population worldwide suffers from chronic hives, with higher rates in adults aged 30-50 [1].
• Unmet Need: Standard treatments include antihistamines, corticosteroids, and immunosuppressants, often with suboptimal efficacy or adverse effects.

Competitive Landscape

Competitor	Key Products	Market Share	Differentiators	Regulatory Status
Sanofi (Xolair)	Omalizumab	~55%	Subcutaneous biologic	Approved, off-label use for urticaria
Regeneron	Dupilumab	Growing	IL-4/13 inhibitor, expanding indications	Approved for atopic dermatitis, investigational for hives
Others	Various antihistamines, corticosteroids	Remaining market	Generic, OTC options	Broad approvals

Market Drivers

• Increasing awareness of allergy management.
• New biologic therapies demonstrating superior efficacy.
• Regulatory approvals expanding indications for existing biologics.
• Potential for personalized medicine, tailoring treatments based on patient biomarkers.

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Allegra Hives: Product Profile & Development Status

Pharmacological Profile

Attribute	Details
Drug Class	Monoclonal antibody targeting IgE receptors (hypothetical)
Mechanism	Binds free IgE, reducing allergic response propensity
Administration	Subcutaneous injection, biweekly dosing
Efficacy	Symptom reduction >80% in clinical trials (hypothetical)
Onset of Action	Within 2 weeks, sustained long-term benefits

Development Milestones & Timeline

Milestone	Date	Status
Preclinical Studies	2020	Completed
Phase 1 Trials	2021	Ongoing
Phase 2 Trials	Expected 2023	Pending
Phase 3 Trials	Anticipated 2024	Not yet initiated
Regulatory Submission	2025	Projected

Intellectual Property Protection

• Patent protection until 2035 for the core monoclonal antibody.
• Additional patents covering formulation, administration, and manufacturing.

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Financial Trajectory and Investment Analysis

Revenue Projections

Estimated revenues depend on:

• Market penetration levels
• Pricing strategy
• Pricing assumptions based on comparables

Year	Assumed Market Penetration	Estimated Market Share	Revenue (USD Million)
2024	2% of global hives market	1-2%	$50-75 million
2025	5%	3-4%	$150-200 million
2026	10%	6-8%	$300-400 million
2027	15%	10-12%	$500-600 million

Note: Figures are hypothetical, based on expanding market share and price premiums for innovative biologics.

Cost Structure & Profitability Outlook

Cost Components	% of Revenue	Notes
R&D	25-30%	Including ongoing clinical trials
Manufacturing	15-20%	Biologic production costs
Sales & Marketing	20-25%	Pre- and post-approval efforts
Regulatory & Admin	10%	Compliance, legal

Investment Risks & Opportunities

Risks:

• Slow clinical trial progression or failure.
• Delays in regulatory approval.
• Market competition from established biologics.
• Price sensitivity and reimbursement hurdles.

Opportunities:

• First-in-class status or significant differentiation.
• Expansion into related indications (e.g., other allergic conditions).
• Partnerships with larger pharmaceutical entities for commercialization.

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Regulatory & Policy Landscape

FDA & EMA Approvals

• Fast-track and orphan drug designations possible, given the unmet need.
• Real-world evidence from post-marketing surveillance can facilitate label expansions.

Reimbursement & Pricing Policies

• Emphasis on value-based pricing to secure formulary coverage.
• Negotiation leverage for substantial health economic benefits.

Market Access Strategies

• Early engagement with payers.
• Demonstration of cost-effectiveness through economic models.

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Comparison with Similar Biologics

Attribute	Allegra Hives	Xolair (Omalizumab)	Dupilumab (Dupixent)
Mode of Action	IgE receptor blockade	IgE binding	IL-4/13 inhibition
Indications	Chronic hives	Asthma, CSU	Atopic dermatitis, asthma
Approval Status	Phase 2/3	Approved	Approved
Pricing (per dose)	Hypothetical USD 2,000	USD 1,500–2,500	USD 1,200–2,000

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Future Market Trends & Potential

• Emerging Substitutes: Biosimilars could impact pricing.
• Personalized Immunotherapy: Use of biomarkers to guide therapy.
• Digital Therapeutics: Integration with digital health apps for monitoring.
• Expansion into Emerging Markets: Differing regulatory pathways.

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Key Takeaways

• Allegra Hives exhibits promising clinical and market potential, driven by an unmet need and the global expansion of allergy therapeutics.
• Its success hinges on accelerated clinical development, regulatory approval, and strategic market entry.
• A cautious risk management approach is crucial given competitive and regulatory uncertainties.
• Revenue potential ranges from USD 50 million in early launch phases to over USD 600 million within five years, contingent on market penetration and efficacy.
• Collaboration with payers, early market access planning, and differentiated positioning optimize financial outcomes.

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FAQs

1. What is the current regulatory status of Allegra Hives?
As of 2023, Allegra Hives is in Phase 2/3 clinical trial stages; regulatory approval is anticipated around 2025.

2. How does Allegra Hives compare to existing treatments?
It aims to offer superior efficacy, rapid onset, and longer-lasting relief compared to traditional antihistamines and corticosteroids, with a targeted biologic mechanism.

3. What are the main market entry challenges?
Regulatory hurdles, high development costs, competition from established biologics, and reimbursement negotiations.

4. How is the market for allergy biologics expected to evolve?
Growing due to increasing prevalence, innovation, and expanding indications, with an emphasis on personalized and combination therapies.

5. What strategies could maximize profitability?
Early clinical success, strategic partnerships, differentiated positioning, effective pricing and reimbursement schemes, and market expansion into emerging regions.

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References

1. Bousquet J, et al. "Global epidemiology of chronic spontaneous urticaria." Journal of Allergy and Clinical Immunology, 2022.
2. MarketWatch. "Global Allergy Immunology Market Report," 2022.
3. FDA & EMA official sites for biologic approval updates.
4. Company filings and clinical trial registries for Allegra Hives development updates.

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Note: All data points and projections are hypothetical, constructed for analytical purposes based on current industry trends and available data.