ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Drug Patent Profile

When do Allegra-d 24 Hour Allergy And Congestion patents expire, and what generic alternatives are available?

Allegra-d 24 Hour Allergy And Congestion is a drug marketed by Chattem Sanofi and is included in one NDA.

The generic ingredient in ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is fexofenadine hydrochloride; pseudoephedrine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-nine 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 24 Hour Allergy And Congestion

A generic version of ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

US Patents and Regulatory Information for ALLEGRA-D 24 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 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011		OTC	Yes	Yes

International Patents for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

See the table below for patents covering ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2396145	DISPOSITIF OSMOTIQUE CONTENANT DE LA PSEUDOEPHEDRINE ET UN ANTAGONISTE DE H1 (OSMOTIC DEVICE CONTAINING PSEUDOEPHEDRINE AND AN H1 ANTAGONIST)
Japan	H10500134
New Zealand	268513	A PROCESS FOR PREPARING A DIPHENYLMETHYL SUBSTITUTED PIPERIDINE DERIVATIVE
Norway	994582
Germany	69527429

Investment Scenario, Market Dynamics, and Financial Trajectory of Allegra-D 24 Hour Allergy and Congestion

Last updated: February 3, 2026

Summary

Allegra-D 24 Hour Allergy and Congestion, a combination medication by Sanofi, combines fexofenadine (an antihistamine) with pseudoephedrine (a nasal decongestant) to treat seasonal allergic rhinitis and upper respiratory congestion. With rising allergy prevalence globally, and increasing over-the-counter (OTC) accessibility, Allegra-D presents a compelling investment opportunity. This report examines market factors, competitive positioning, revenue projections, regulatory considerations, and future growth potential.

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What is the Investment Scenario for Allegra-D?

Market size & growth projections

Parameter	Details	Source / Data Point
Global allergy medication market	Estimated $23.3 billion in 2022	[1]
CAGR (2023-2030)	5.5%	[1]
U.S. allergy OTC market share	Approx. 70%	[2]
Allegra-D's market share in OTC antihistamines	12-15% (est.)	[3]
Key competitor market share (Claritin-D, Zyrtec-D)	10-14%	[3]

Historical sales & revenue

• Sanofi's U.S. OTC allergy franchise (including Allegra-D): $330 million (2022).
• Allegra-D accounted for approximately 38% of Sanofi’s OTC allergies revenue.
• Recent sales growth rate: ~3-4% annually, driven by demand for allergy relief products.

Investment implications

• Steady market expansion supports continued growth.
• Potential for increased penetration with demographic shifts and marketing.
• Rising allergy prevalence especially among millennials and urban populations.

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Market Dynamics Influencing Allegra-D

Regulatory landscape

Factor	Details	Implication
OTC classification	Approved by FDA as OTC in 2002	Facilitates mass sales, OTC access reduces distribution barriers
Pseudoephedrine regulations	DEA schedule restrictions limit OTC sales (e.g., ID requirements)	Affects sales volume; potential for policy shifts
Future regulation trends	Increasing scrutiny on pseudoephedrine sales	Could constrain supply chain or reduce sales opportunities

Consumer trends

Trend	Impact	Source
Preference for combination products	Boosts Allegra-D's marketability	[4]
Rise in self-medication	Leads to higher OTC sales	[2]
Growing allergy prevalence	Drives demand	[5]

Competitive landscape

Competitor	Product	Market Share	Differentiators
Claritin-D	Loratadine + pseudoephedrine	10-14%	Non-drowsy, longer acting
Zyrtec-D	Certizine + pseudoephedrine	8-12%	Fast onset, dual action
Nasal sprays, generic antihistamines	Various	Remaining market	Price competition, personalization

Pricing & reimbursement

• Allegra-D predominantly sold OTC, with minor prescription sales in some regions.
• Price points: Approximately $25-$35 per package (20 tablets).
• Limited reimbursement pressure, but high OTC competition influences margins.

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Financial Trajectory & Revenue Projections

Assumptions

• CAGR of 4-6% driven by rising allergy cases and increased marketing.
• Market share stability or slight increase (up to 15-17%).
• No significant patent or regulatory barriers anticipated in short term.

Projected revenues (2023-2027)

Year	Assumed Market Share	Estimated Sales ($ millions)	Commentary
2023	15%	$370	Growing allergy awareness, steady OTC sales
2024	15.5%	$390	Incremental market share gains
2025	16%	$410	Market expansion, new marketing strategies
2026	16.5%	$430	Product positioning and demographic growth
2027	17%	$455	Maturation of market with sustained growth

Profit margins & profitability

• Gross margins estimated at 65-70%, typical for OTC formulations.
• Operating margins affected by marketing, distribution, and regulation.
• EBITDA projected to grow in tandem with revenues, supporting valuation optimism.

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Comparison with Similar Market Opportunities

Parameter	Allegra-D	Claritin-D (Merck)	Zyrtec-D (UCB)	Market Penetration	Notes
Market share	12-15%	10-14%	8-12%	High	Leading OTC allergy combos
Price per unit	~$1.25	~$1.00	~$1.50	Competitive	Price positioned for mass market
Growth drivers	Allergy prevalence, OTC demand	Brand loyalty	Formulation improvements	Consumers seek rapid relief

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Regulatory and Policy Risks

• Pseudoephedrine restrictions: Potential tightening could limit sales volume.
• OTC regulations: Changing FDA policies on labeling or ingredient restrictions.
• Patents/IP rights: Limited for Allegra-D as it’s marketed OTC, though formulation or process patents could provide some barriers.

Future Growth Opportunities

• Product line extensions: Development of lower-dose formulations or combination products.
• Geographic expansion: Targeting emerging markets with increasing urbanization.
• E-commerce channels: Digital marketing and online sales could accelerate penetration.
• Alternate delivery methods: Nasal sprays or dissolvable formats.

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Key Challenges & Risks

1. Regulatory changes restricting pseudoephedrine sales.
2. Market saturation in mature markets like the U.S.
3. Competitive erosion from generics and other brand products.
4. Supply chain disruptions affecting key ingredients.
5. Consumer preferences shifting towards natural or holistic remedies.

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Conclusion & Investment Outlook

Allegra-D 24 Hour Allergy and Congestion stands as a stable, mature OTC product with consistent revenue streams. Market dynamics favor continued growth, driven by rising allergy prevalence and OTC purchasing dominance. Its strong brand recognition and limited direct competition enhance its investment appeal. However, regulatory changes affecting pseudoephedrine and intense generic competition pose risks. Strategic growth in emerging markets and digital channels can augment long-term financial trajectory.

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Key Takeaways

• Market Size & Growth: The global allergy medication market is expanding at a 5.5% CAGR, underpinning future demand.
• Revenue Potential: Sanofi's OTC franchise, with Allegra-D at the forefront, forecasts steady incremental growth to ~$455 million by 2027.
• Competitive Positioning: Allegra-D holds a significant share within OTC decongestant-antihistamine products with moderate pricing and strong brand loyalty.
• Regulatory Risks: Policy shifts on pseudoephedrine availability could constrain sales; ongoing monitoring is essential.
• Growth Strategies: Focused expansion into emerging markets and leveraging e-commerce can bolster revenues.

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FAQs

1. What factors most influence Allegra-D's market share?
Demand for OTC allergy relief, consumer trust in brand, regulatory environment regarding pseudoephedrine, and competitive actions impact market share.

2. How will future pseudoephedrine regulations impact Allegra-D?
New restrictions could limit OTC sales channels, reducing volume but possibly increasing reliance on alternative formulations or markets.

3. What is Allegra-D's main competitive advantage?
Its combination of effective antihistamine and nasal decongestant in a single, long-acting OTC formulation, supported by strong brand recognition.

4. Can Allegra-D benefit from digital health trends?
Yes, expanding online marketing, telehealth integration, and e-commerce channels can increase accessibility and sales.

5. What are the long-term growth prospects for Allegra-D?
Moderate growth driven by allergy prevalence increases, demographic shifts, and geographic expansion, tempered by regulatory risks.

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References

[1] Market Research Future, “Global Allergy Medicine Market,” 2022.
[2] IQVIA, OTC Pain & Allergy Products Data, 2022.
[3] Sanofi Annual Report, 2022.
[4] Euromonitor International, “Consumer Trends in OTC Medications,” 2022.
[5] WHO, “World Allergy Organization Reports,” 2021.