ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Drug Patent Profile

Which patents cover Allegra-d 12 Hour Allergy And Congestion, and when can generic versions of Allegra-d 12 Hour Allergy And Congestion launch?

Allegra-d 12 Hour Allergy And Congestion is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allegra-d 12 Hour Allergy And Congestion

A generic version of ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION was approved as fexofenadine hydrochloride; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on June 22^nd, 2011.

Summary for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	64
DailyMed Link:	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION at DailyMed

Pharmacology for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Drug Class	Histamine-1 Receptor Antagonist alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

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-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011		OTC	Yes	Yes

Expired US Patents for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011

International Patents for ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION

See the table below for patents covering ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	318246
Denmark	133080
Hungary	9503719

Market Dynamics and Financial Trajectory for Allegra-D 12 Hour Allergy and Congestion

Last updated: August 4, 2025

Introduction

Allegra-D 12 Hour, a dual-action antihistamine combining fexofenadine with pseudoephedrine, addresses seasonal allergic rhinitis and congestion. Its positioning within the allergy relief segment continues to evolve against a backdrop of shifting consumer preferences, regulatory landscapes, and competitive pressures. Analyzing demand drivers, market size, competitive dynamics, and financial prospects is essential for stakeholders evaluating investment, development, and commercial strategies.

Market Overview

The global allergy medication market was valued at approximately USD 18.7 billion in 2021 and is projected to reach USD 23.8 billion by 2028, exhibiting a CAGR of around 3.4% (2022-2028) [1]. Segmentally, oral antihistamines like Allegra-D occupy a significant share, driven by rising allergic conditions, especially in urban populations.

Allegra-D’s unique two-device formulation offers symptomatic relief from both nasal congestion and allergic symptoms—a combination that sustains consumer demand despite increased regulation of pseudoephedrine. In the U.S., Allegra-D 12 Hour remains a prominent OTC option, especially favored among consumers seeking long-lasting effects.

Demand Drivers

Rising Prevalence of Allergic Conditions

Increased rates of allergic rhinitis in North America, Europe, and Asia-Pacific underpin sustained demand for effective antihistamines. Factors include urban pollution, climate change, and heightened awareness. The Asthma and Allergy Foundation of America reports that over 60 million Americans suffer from allergies, with growth trends paralleling urbanization [2].

Consumer Preference for Long-Acting Formulations

Consumers value convenience, seeking medications providing 12-hour symptom control to reduce dosing frequency. Allegra-D 12 Hour’s efficacy and two-device delivery meet these preferences, sustaining its market share.

Regulatory Environment

While pseudoephedrine-containing products face purchase restrictions under the Combat Methamphetamine Epidemic Act of 2005 in the U.S., pharmaceutical companies have adapted through behind-the-counter sales, electronic tracking, and packaging innovations, ensuring continued supply.

Over-the-Counter Accessibility

Allegra-D is classified as OTC in the U.S., enhancing accessibility, especially among working adults and seasonal allergy sufferers. This over-the-counter status fosters consistent cash flow and repeat purchases.

Competitive Landscape

Key Players and Products

• Sanofi's Allegra (Fexofenadine): Monopoly on Allegra D’s active component, with generic versions expanding options.
• Zyrtec (Certizine): Competes on efficacy and price.
• Claritin (Loratadine): Offers similar 24-hour relief without decongestants.
• Nasal sprays and other combination products: Market responses to consumer demand for alternative delivery methods.

Market Penetration and Brand Loyalty

Allegra-D’s recognition and clinician recommendations contribute to consumer loyalty. However, generic competition erodes margins, and price-sensitive consumers may favor less expensive alternatives.

Innovation and Line Extensions

New formulations with improved delivery mechanisms or combination therapies are emerging. Despite limited recent innovation in Allegra-D, firms explore alternative delivery devices and formulations to maintain competitiveness.

Regulatory and Legal Factors

The pseudoephedrine component’s regulatory constraints influence manufacturing and distribution strategies. Ongoing legislative reviews could impact product availability, while patent expirations for active ingredients signal potential for generic entry, increasing price competition.

Financial Trajectory Analysis

Revenue Trends

Allegra-D historically accounts for a significant portion of Sanofi’s OTC allergy revenues, with U.S. sales representing the majority. Pre-pandemic, annual sales hovered around USD 600-700 million nationwide [3].

However, recent years have shown plateauing or modest declines due to increasing generic competition, regulatory constraints, and evolving consumer preferences.

Profitability and Margins

Brand-name Allegra-D commands premium pricing versus generics. Nonetheless, the cost of maintaining dual-device packaging and regulatory compliance affects margins. The entry of generics threatens to reduce profit margins substantially, pressing the need for innovation or repositioning.

Forecasted Growth

Based on current market trends, revenue from Allegra-D is expected to stabilize or decline modestly over the next 3-5 years. Factors influencing this include:

• Accelerated generic penetration.
• Regulatory shifts increasing barriers for pseudoephedrine products.
• Consumer preference shifts towards natural remedies or alternative relief options.
• Potential reformulations or new delivery systems that improve compliance and efficacy.

Investment and Development Outlook

Pharmaceutical firms may direct R&D toward novel delivery mechanisms fulfilling consumer demands for ease and efficacy. Investment in OTC marketing campaigns can reinforce brand loyalty, although margins face downward pressure.

Market Risks and Opportunities

Risks

• Regulatory restrictions: Stricter pseudoephedrine regulations could curtail product availability.
• Generic erosion: The proliferation of generics diminishes revenue potential.
• Market saturation: High penetration levels limit growth avenues.
• Shift towards natural or OTC alternatives: Consumer skepticism about synthetic medications may influence sales.

Opportunities

• Product innovation: Enhanced formulations or delivery devices can rejuvenate sales.
• Geographic expansion: Emerging markets exhibit rising allergy prevalence and expanding OTC channels.
• Combination therapies: Pairing Allegra-D with complementary agents could create new market segments.
• Digital marketing and telehealth integration: Increasingly drives OTC product awareness.

Conclusion

Allegra-D 12 Hour maintains a robust position within the allergy relief market, characterized by consistent demand rooted in a growing allergic population and consumer preference for long-lasting relief. However, fierce competition, regulatory constraints, and generics threaten its financial trajectory. Strategic innovation, geographic expansion, and targeted marketing are critical for sustaining profitability.

Key Takeaways

• Market stability stems from high consumer awareness, long-acting efficacy, and OTC accessibility.
• Regulatory constraints on pseudoephedrine complicate supply but have catalyzed reformulation efforts.
• Generic competition remains the primary threat to revenue and profit margins.
• Product innovation in delivery systems and formulations offers pathways to reignite growth.
• Emerging markets represent significant future revenue opportunities amid rising allergy prevalence.

FAQs

1. What are the main factors influencing Allegra-D’s market performance?
   Demand driven by rising allergy prevalence, consumer preference for long-acting relief, regulatory constraints on pseudoephedrine, and competition from generics and alternative therapies.

2. How does regulation affect Allegra-D's sales?
   Regulations restrict pseudoephedrine sales, necessitating behind-the-counter measures and impacting supply chain dynamics. These laws influence pricing, availability, and consumer access.

3. What is the outlook for generic competition for Allegra-D?
   Generics threaten to significantly lower sales margins as they gain market share, particularly after patent expirations for active ingredients. Manufacturers may need to innovate or differentiate to maintain profitability.

4. Are there opportunities for growth in non-U.S. markets?
   Yes. Developing regions with increasing allergy prevalence and expanding OTC channels provide growth avenues, especially if regulatory environments are favorable.

5. What strategic moves could sustain Allegra-D’s market position?
   Investments in novel delivery technologies, geographic expansion, marketing tailored to consumer preferences, and exploring combination therapies can help maintain market relevance.

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Sources

[1] Fortune Business Insights, "Personalized Medicine Market Size, Share & Industry Analysis," 2022.
[2] Asthma and Allergy Foundation of America, "Allergy Facts and Figures," 2022.
[3] Sanofi Annual Reports, 2019-2022.