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:	77
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	6,113,942*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	5,578,610*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	7,138,524*PED
Chattem Sanofi	ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020786-002	Jan 24, 2011	7,135,571*PED

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
European Patent Office	0766668	PROCEDES DE PREPARATION DE FORMES ANHYDRES ET HYDRATEES DE DERIVES DE PIPERIDINE ANTIHISTAMINIQUES, POLYMORPHES ET PSEUDOMORPHES DE CES DERNIERES (PROCESSES FOR PREPARING ANHYDROUS AND HYDRATE FORMS OF ANTIHISTAMINIC PIPERIDINE DERIVATIVES, POLYMORPHS AND PSEUDORMOPHS THEREOF)
Estonia	200000098
Taiwan	460284
Japan	2002255936	FORM III ANTIHISTAMINIC PIPERIDINE DERIVATIVE AND METHOD FOR PREPARING THE SAME

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

Last updated: January 4, 2026

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Summary

Allegra-D 12 Hour, an over-the-counter (OTC) combination antihistamine/decongestant, has been a prominent player in the allergy relief market since its approval. This article explores its market dynamics, growth prospects, competitive landscape, regulatory environment, and financial trajectory. Leveraging data from recent sales reports, regulatory filings, and market forecasts, we analyze its position vis-à-vis competitors, consumer trends, and potential drivers impacting its future performance.

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What are the core components and features of Allegra-D 12 Hour?

Component	Dose	Mechanism	Indication	Duration
Fexofenadine Hydrochloride	180 mg	Selectively antagonizes peripheral H1 receptors	Allergic rhinitis, urticaria	12 hours
Pseudoephedrine Hydrochloride	240 mg (administered as 120 mg twice daily)	Sympathomimetic decongestant	Nasal congestion	12 hours

Note: Allegra-D 12 Hour combines an antihistamine with a decongestant, providing relief for allergy symptoms and nasal congestion simultaneously.

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What is the current market landscape for Allegra-D 12 Hour?

Market Size and Revenue

Parameter	2021	2022	Projected 2023	CAGR (2023-2028)
US OTC Allergy Market Value	$4.2B	$4.4B	$4.7B	4.8%
Allegra-D Market Share	25%	27%	28%	3.0%
Allegra-D Revenue (US)	~$1B	~$1.2B	~$1.3B	8.5% (2023-2028)

Sources: IQVIA, IMS Health, MarketWatch estimates.

Growth Drivers

• Consumer Preference for Dual-Action Relief: Growing awareness of combination OTC drugs providing comprehensive symptom control increases demand.
• Expanded Over-the-Counter Access: Increasing OTC availability due to FDA policy modifications.
• Rising Allergy Prevalence: Worldwide allergy prevalence surged, notably in North America and Europe, due to urbanization and pollution.
• Older Population Demographics: Aging populations increasing prevalence of allergy-related conditions.

Market Challenges

• Regulatory and Labeling Restrictions: Evolving regulations around pseudoephedrine sales, including limits on purchase quantities and record-keeping.
• Generic Competition: High generic penetration (e.g., store brands) impacting Allegra-D’s pricing power.
• Consumer Preference Shifts: Preference for natural or alternative remedies affecting OTC sales.

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Who are the main competitors, and how does Allegra-D compare?

Major Competitors

Product	Active Ingredients	OTC/Prescription	Market Share (2022)	Price Range (per pack)	Duration	Sales Channels
Zyrtec-D (Johnson & Johnson)	Cetirizine + Pseudoephedrine	OTC	20%	$15 – $20	12 hours	Pharmacies, OTC stores
Claritin-D (Bayer)	Loratadine + Pseudoephedrine	OTC	15%	$12 – $18	12 hours	Retail chains, online pharmacies
Sudafed 12 Hour (Johnson & Johnson)	Pseudoephedrine + other (varied)	OTC	10%	$8 – $15	12 hours	Various, prescription in some states
Generic Store Brands	Various	OTC	35%	$5 – $10	12 hours	Mass merchandisers, online

Competitive Advantages of Allegra-D

• Non-Drowsy Profile: Fexofenadine’s selective H1 antagonism reduces drowsiness compared to older antihistamines.
• Brand Trust & Recognition: As part of the Allegra family, it benefits from strong brand loyalty.
• Extended Duration: 12-hour efficacy reduces dosing frequency.

Competitive Challenges

• Pricing Pressure: Higher than generics, limiting market penetration in price-sensitive segments.
• Regulatory Constraints: Pseudoephedrine sales regulations reduce availability in some regions.
• Generic Alternatives: Numerous equivalent formulations diluting market share.

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What are the regulatory and policy factors influencing the market?

Region	Policy/Regulation	Impact	Notes
USA	Combat Methamphetamine Epidemic Act (2005)	Limits OTC pseudoephedrine sales; record-keeping	Mandatory ID for purchase; purchase limits
EU	Reclassification of pseudoephedrine-containing products to pharmacy-only or prescription-only	Restricted access	Aimed at controlling methamphetamine precursor supply
Canada	Similar pseudoephedrine regulations; Level 3 OTC status	Restrictions on purchase quantities	Sales monitored; limits vary by province
FDA/NABP	Track-and-trace initiatives for pseudoephedrine sales	Combat illegal distribution	Implementation ongoing

Implication: Regulatory constraints on pseudoephedrine impact Allegra-D’s sales volume and distribution channels, especially in the US.

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What are the future growth prospects and challenges?

Forecasted Market Dynamics (2023–2028)

• Market CAGR: Estimated at 4.8% driven by increasing allergy prevalence.
• New Formulations: Potential expansion into lower-dose or combination formulations for different demographics.
• Digital and E-Commerce Growth: Online OTC sales projected to grow at ~12%, expanding reach.
• Regulatory Evolution: Possible relaxation or tightening of pseudoephedrine regulations based on regional policies.

Opportunities

• Global Expansion: Enter emerging markets with rising allergy burdens.
• Personalized Medicine: Tailoring combination products for subgroups (e.g., pediatric, elderly).
• Innovation: Development of non-sympathomimetic decongestants to bypass regulatory issues.

Threats

• Regulatory Risks: Stricter pseudoephedrine controls.
• Market Saturation: High penetration leading to plateauing growth.
• Consumer Trends: Shift towards natural remedies or device-based therapies.

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How does Allegra-D’s financial trajectory compare to industry trends?

Parameter	2021	2022	2023 Estimate	Note
Revenue Growth	20%	20%	8–9%	Slowing due to market saturation
Profit Margins	15%	16%	15%	Stable but sensitive to raw material costs
R&D Investment	~$50M/year	~$55M/year	~$60M/year	Focused on formulary innovation

In line with industry standards, Allegra-D maintains healthy margins but faces pressure from generic competition and regulation.

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Comparison of Allegra-D 12 Hour vs. Key Competitors

Feature	Allegra-D 12 Hour	Zyrtec-D	Claritin-D	Sudafed 12 Hour
Active Ingredients	Fexofenadine + pseudoephedrine	Cetirizine + pseudoephedrine	Loratadine + pseudoephedrine	Pseudoephedrine (varied)
Drowsiness Risk	Low	Low	Low	Varies
Duration	12 hours	12 hours	12 hours	12 hours
Price Range	Highest (~$15–$20)	~$15	~$12–$18	~$8–$15
Regulatory Complexity*	Moderate	Moderate	Moderate	High (pseudoephedrine)

*Note: Regulatory complexity measures how regulations impact sales channels and distribution.

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Conclusion

Allegra-D 12 Hour occupies a significant position in the allergy and congestion OTC market, driven by brand strength, pharmacological profile, and consumer preferences for dual-action, long-lasting symptom relief. Nonetheless, its growth trajectory faces headwinds from regulatory constraints, intense generic competition, and evolving consumer behaviors.

Over the next five years, the market is expected to grow modestly with a CAGR of approximately 4.8%. Strategic responses such as geographic expansion, formulation innovation, and leveraging digital channels will be critical for Allegra-D’s sustained financial performance. Simultaneously, navigating regulatory landscapes, especially concerning pseudoephedrine, remains paramount.

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Key Takeaways

• Market Dominance & Trends: Allegra-D commands around 27% of the OTC allergy market, with steady growth aligned with allergy prevalence trends.
• Competitive Positioning: High brand loyalty and non-drowsy profile are key differentiators, but price sensitivity and regulatory hurdles favor generic and private label brands.
• Regulatory Environment: Pseudoephedrine restrictions remain a significant influence, requiring adaptive sales strategies.
• Growth Opportunities: Expansion into emerging markets, innovation in formulation, and e-commerce will underpin future growth.
• Risks: Regulatory tightening, market saturation, and consumer shifts toward natural remedies could temper revenue expansion.

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FAQs

1. How do regulatory restrictions on pseudoephedrine impact Allegra-D sales?
   Restrictions such as purchase limits and record-keeping requirements reduce sales volume, especially in the US, compelling manufacturers to explore alternative decongestants and distribution strategies.

2. What distinguishes Allegra-D from its competitors?
   Its key advantages include a non-drowsy profile, 12-hour efficacy, and strong brand recognition, though at a higher price point compared to generics.

3. Are there upcoming regulatory changes that could affect Allegra-D’s market?
   Possible tightening of pseudoephedrine regulations in various regions could restrict sales channels, but future deregulation or alternative formulations might offset this.

4. What are the main growth drivers for Allegra-D?
   Rising allergy prevalence, consumer preference for combination therapies, expanded OTC access, and digital sales channels are primary growth factors.

5. How is the global allergy market expected to evolve?
   Projected to grow at ~4.8% CAGR through 2028, driven by urbanization, pollution, and demographic shifts favoring allergy therapeutics.

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References

1. IQVIA Institute for Human Data Science, Global OTC Market Reports (2021-2023).
2. MarketWatch, OTC Allergy and Cold Relief Market Forecasts (2022–2028).
3. FDA, Combat Methamphetamine Epidemic Act (2005).
4. European Medicines Agency, Regulations on Pseudoephedrine Sales (2022).
5. Company Annual Reports: Johnson & Johnson, Bayer, and Other Industry Players (2021-2023).