ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Drug Patent Profile

Which patents cover Allegra-d 24 Hour Allergy And Congestion, and when can generic versions of Allegra-d 24 Hour Allergy And Congestion launch?

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	77
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
DailyMed Link:	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION at DailyMed

Pharmacology for ALLEGRA-D 24 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 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

Expired US Patents for ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011
Chattem Sanofi	ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021704-002	Jan 24, 2011

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
Japan	3658291
Canada	2147126	DERIVES DE LA PIPERIDINE ET METHODE DE PREPARATION (PIPERIDINE DERIVATIVES AND PROCESS FOR THEIR PRODUCTION)
Argentina	007358	UN DISPOSITIVO OSMOTICO MULTICAPA PARA EL SUMINISTRO CONTROLADO DE UNO O MAS AGENTES ACTIVOS A UNO O MAS AMBIENTES DE USO.
Australia	2634901
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)
Germany	60134387

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is the product’s revenue model and where does it sit in the allergy-care stack?

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION is an OTC, fixed-dose combination allergy product built around fexofenadine plus pseudoephedrine (extended-release). The commercial engine for this class is not prescription volume; it is seasonal retail turnover, pharmacy counter conversion, and promotional pricing tied to cold-and-allergy cycles.

Core demand drivers

• Seasonality and weather: Allergy incidence increases in peak pollen and seasonal respiratory periods; demand typically spikes in spring and fall.
• Cold and allergy overlap: Pseudoephedrine-based congestion relief captures patients treating “allergies plus stuffy nose” rather than antihistamine-only use.
• OTC switching dynamics: Consumers move between equivalent OTC congestion-antihistamine combinations based on perceived speed of relief, brand trust, and price.

Place in the portfolio

• Fexofenadine-based OTC products sit in the “second-generation antihistamine” lane versus older sedating antihistamines.
• The “-D” pseudoephedrine combination segment is structurally different from non-decongestant antihistamines due to additional regulatory controls and patient handling at point of sale.

How does regulation shape availability, pricing power, and sell-through?

Pseudoephedrine products face controlled distribution requirements in the US, which affects retail execution and purchasing friction.

Regulatory and retail implications for pseudoephedrine combos

• Retailers apply ID checks and transaction limits (framework under US federal methamphetamine precursor controls).
• Availability can be constrained by store-level compliance practices and inventory handling.
• Market shares tilt toward brands with strong distribution relationships and retailer familiarity.

Business impact on financial trajectory

• Pricing power is less about pure clinical differentiation and more about execution reliability: consistent inventory, compliant stocking, and fast replenishment during peak seasons.
• Promotion cycles (coupons, multi-buy offers, and end-cap placements) matter more than long-term brand equity in OTC congestion segments.

What market dynamics influence growth or decline over a 2- to 5-year horizon?

The market for OTC allergy and congestion products has recurring forces that move unit volume and net sales.

Supply and competitive pressure

• Multiple OTC combinations exist across categories:
  • Second-generation antihistamine alone (non-decongestant)
  • Second-generation antihistamine plus different decongestants
  • Non-antihistamine congestion-only products
• Competition intensifies when retailers expand private label or when large brands run aggressive seasonal promotions.

Consumer substitution

• When prices rise, consumers typically trade down to lower-cost equivalents within congestion-antihistamine or congestion-only categories.
• When perceived relief is weak or product “feel” (onset, congestion impact) is inconsistent, churn increases.

Seasonal promotional behavior

• The segment is promo-heavy: price and retailer placement drive category conversion during peak allergy months.
• Net sales can grow even with flat underlying unit growth if mix shifts toward higher-priced formats or if promotional intensity moderates.

How does ALLEGRA-D’s lifecycle typically behave for an OTC combination product?

For an established OTC combination brand, the financial path usually follows a pattern:

• Early stage: share capture from prior congestion-allergy standards, fast retailer adoption.
• Mature stage: share stability with incremental gains through seasonal promotion and packaging variants.
• Later maturity: flat-to-declining units if category headwinds increase (private label, stronger competitors, weaker seasonal peaks), with net sales supported by price/mix and reduced promotional depth.

For ALLEGRA-D specifically, the stable part of the model is that:

• congestion plus allergy symptom treatment is persistent unmet convenience demand,
• second-generation antihistamine positioning stays durable versus older sedating alternatives,
• pseudoephedrine combo use keeps a distinct user set that does not fully substitute into antihistamine-only products.

What are the key financial levers that determine net sales and gross margin?

Because this is an OTC branded combo, net sales and gross margin move through a smaller set of levers than prescription launches.

Net sales levers

• Seasonal unit volume in peak months.
• Price per unit (MSRP and realized pricing after retailer discounts and promotions).
• Channel mix (mass, club, grocery, pharmacy).
• Package economics (store brand or competitor pack sizes influence shelf price comparisons).

Gross margin levers

• Manufacturing scale and sourcing for active ingredients and extended-release formulation.
• Trade spend (co-op advertising, retailer allowances, slotting during peak seasons).
• Promotional intensity (depth and duration of seasonal discounts).

Profit sensitivity

• In OTC, promotional depth can move earnings quickly: the segment is competitive, and demand is seasonal but price-sensitive.

Where are the patent and exclusivity edges that can influence longer-run revenue?

Long-run trajectory for OTC drugs usually depends on:

• the status of active ingredient patents and formulation/exclusivity that can constrain generic or authorized generic entry,
• the status of combination intellectual property (fixed-dose plus extended-release),
• the presence and timing of generic competition that compresses price and margins.

For ALLEGRA-D 24 HOUR, market outcomes hinge on when competitors can legally sell equivalent formulations and how aggressively retailers stock them. However, without a verified, up-to-date exclusivity and patent status dataset for the exact combination and dosage form, a complete and precise financial forecast (including post-expiration share loss curves) cannot be constructed.

What market share and price dynamics typically happen in OTC antihistamine-decongestant combos once generics arrive?

When generic equivalents enter for established OTC combo brands, financial trajectory generally shifts to:

• downward pressure on net price as retailers widen shelf access for lower-cost equivalents,
• trade spend increase as the branded firm defends shelf position,
• mix shift toward larger packs or promoted SKUs that maintain absolute dollar sales,
• unit volatility tied to promotion cadence and seasonal peaks.

For an established brand like ALLEGRA-D, the brand typically retains some share through:

• consumer brand preference,
• retailer shelf allocation favoring known movers,
• perceived efficacy and tolerability positioning.

But the magnitude of erosion depends on the exact strength of combination/formulation protection and the speed and coverage of generic entrants.

Financial trajectory summary: what a realistic baseline path looks like

Given OTC realities, ALLEGRA-D 24 HOUR’s financial trajectory typically reflects three drivers:

1. Seasonality governs topline spikes
2. Retail pricing and promotional depth governs realized net
3. Generic/authorized generic penetration governs longer-run margin compression

A plausible directional read for established OTC combination brands is:

• Short run (season-to-season): net sales oscillate with pollen/cold cycles and promotional intensity; margins swing with discount depth.
• Medium run (multi-year): absent a material protection expiry or competitor shock, the baseline is stable brand share with periodic promotional optimization.
• Long run (post-meaningful competition entry): net sales growth slows or declines while gross margin compresses.

A precise numeric forecast requires verified proprietary and regulatory market data. This analysis is limited to structural dynamics and commercial mechanics.

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Key Takeaways

• ALLEGRA-D 24 HOUR’s market is driven by seasonal retail turnover and OTC point-of-sale execution rather than prescription demand.
• The pseudoephedrine component creates distribution and compliance friction, which can favor brands with reliable retail handling and shelf continuity.
• Financial outcomes track three variables: seasonal units, realized net price after promotion, and competitive/generic penetration over time.
• Over a multi-year horizon, the segment’s economics tend to move from brand-defense pricing toward promotional trade-offs once equivalent competition widens.

FAQs

1. Is ALLEGRA-D 24 HOUR a prescription or OTC product?
   It is an OTC product sold through retail channels.

2. What symptom set does ALLEGRA-D 24 HOUR target?
   Allergy symptoms plus nasal congestion, using a combination of an antihistamine and a decongestant.

3. What most influences quarterly performance for OTC allergy-decongestant brands?
   Seasonality and the depth/timing of retail promotions.

4. Why does pseudoephedrine affect the business model beyond clinical efficacy?
   It changes retailer purchasing friction through controlled-distribution compliance, which affects availability and execution.

5. What is the main long-run threat to branded OTC combo revenue?
   Increased competitive coverage from equivalent products, including generic penetration that compresses net price and margins.

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References

[1] U.S. Food and Drug Administration. Pseudoephedrine and Ephedrine Products Regulation (Methamphetamine Precursor Controls). FDA website.
[2] U.S. Drug Enforcement Administration. Combat Methamphetamine Epidemic Act (CMEA) and precursor control requirements for pseudoephedrine-containing products. DEA website.
[3] FDA. OTC Drug Product Safety and Effectiveness Reviews and Related Guidance (OTC overview). FDA website.