Last Updated: June 9, 2026

ALLEGRA ALLERGY Drug Patent Profile


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

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

The generic ingredient in ALLEGRA ALLERGY 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 Allergy

A generic version of ALLEGRA ALLERGY was approved as fexofenadine hydrochloride by L PERRIGO CO on February 24th, 2020.

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Questions you can ask:
  • What is the 5 year forecast for ALLEGRA ALLERGY?
  • What are the global sales for ALLEGRA ALLERGY?
  • What is Average Wholesale Price for ALLEGRA ALLERGY?
Summary for ALLEGRA ALLERGY
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 110
Clinical Trials: 35
Patent Applications: 3,282
What excipients (inactive ingredients) are in ALLEGRA ALLERGY?ALLEGRA ALLERGY excipients list
DailyMed Link:ALLEGRA ALLERGY at DailyMed
Recent Clinical Trials for ALLEGRA ALLERGY

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Food and Drug Administration (FDA)Early Phase 1
University of California, San FranciscoEarly Phase 1
University of Alabama at BirminghamPhase 2

See all ALLEGRA ALLERGY clinical trials

Pharmacology for ALLEGRA ALLERGY

US Patents and Regulatory Information for ALLEGRA ALLERGY

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 ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-007 Jan 24, 2011 OTC Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chattem Sanofi ALLEGRA ALLERGY fexofenadine hydrochloride TABLET;ORAL 020872-010 Jan 24, 2011 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: June 3, 2026

Allegra Allergy (Fexofenadine) Market Dynamics and Financial Trajectory: Sales Trends, Competitive Pressure, and Patent/Exclusivity Exposure

Allegra Allergy is a U.S. and global branded brand of fexofenadine, an antihistamine marketed for allergic rhinitis and other allergy-related indications. Its financial trajectory is shaped by (1) the early loss of brand exclusivity for immediate-release fexofenadine products, (2) generic saturation across major dosage strengths, and (3) ongoing brand repositioning through line extensions (notably ODT) and sustained distribution in OTC channels. In the U.S., the competitive landscape is structurally unfavorable for brand growth because core fexofenadine products are long past patent protection and rely on OTC pull-through rather than protected pricing.

How has Allegra Allergy (fexofenadine) performed financially in the US market?

What has driven Allegra Allergy revenue after generic entry?

Allegra’s branded revenue has moved from “protected brand growth” to “OTC share management.” The post-generic phase typically shifts economics from patent-driven pricing power to channel execution:

  • Wholesale acquisition cost and retail price alignment against generics
  • Promotional cadence for OTC shelf visibility
  • Pharmacy counter and e-commerce discoverability in search and PDP conversion
  • Line extension strategy (e.g., formulations positioned for compliance or faster convenience needs)

What are the key commercial KPIs for an OTC antihistamine brand?

Brand P&L in OTC allergy depends on:

  • Net sales vs. category growth (seasonality impacts monthly revenue profiles)
  • Trade spend as a share of sales (OTC competition forces higher retailer and distributor incentives)
  • Generic penetration rates by strength and pack size
  • Share metrics: Rx-to-OTC is not relevant here, but category share vs. competing H1 antihistamines is
  • Stocking and out-of-stock risk in mass and pharmacy chains

Seasonality impact

Allergy antihistamines show predictable peaks in spring and early fall allergy seasons. Revenue is concentrated in those windows; financial trajectory depends on whether the brand holds incremental share during peak weeks versus losing it to generics and other H1 competitors.

Which competitors pressure Allegra Allergy pricing and market share?

Direct H1 antihistamine competition

Allegra faces competition across the OTC second-generation antihistamine class and adjacent allergy symptom products:

  • Cetirizine (e.g., Zyrtec and generics)
  • Loratadine (e.g., Claritin and generics)
  • Levocetirizine (e.g., Xyzal and generics where applicable)
  • Fexofenadine’s own generics (same active, lower-cost packs)
  • Multi-symptom allergy formulations (nasal steroid, combination regimens, and add-ons)

What changes the competitive balance each season?

  • Pill preference and dosing convenience
  • “Non-drowsy” perceptions and labeling differentiation
  • Unit dose and pack price thresholds that influence mass retailer planograms
  • Switching behavior driven by perceived symptom control and tolerability rather than efficacy differentiation in claims

How does Allegra compare vs. Zyrtec and Claritin in market dynamics?

A practical way to view relative dynamics post-generic is:

  • Price: second-generation brands vs. generics cluster tightly in consumer price tolerance bands
  • Availability: store-level availability and online substitution matter as much as claims
  • Perceived product identity: brands with long-running OTC equity (Zyrtec, Claritin) can maintain share longer even after generics dilute the category

What are the main market drivers for fexofenadine demand?

1) Allergy epidemiology and season length

Demand correlates with:

  • Regional pollen profiles and weather patterns
  • Duration of allergy seasons (longer seasons increase baseline consumption)
  • Urban vs. rural population exposure patterns

2) OTC distribution scale

Fexofenadine products are sold through:

  • Mass retail
  • Pharmacy chains
  • Club and warehouse channels
  • E-commerce and subscription-like purchasing behavior

The market dynamic is not only category growth but also the ability to keep shelf presence during peak demand spikes.

3) Consumer preference for second-generation antihistamines

Fexofenadine competes in the “non-sedating” consumer segment. Even where efficacy differences are modest, consumer willingness to trial depends on:

  • Dosing simplicity
  • Taste and mouthfeel for dissolvable formats (where offered)
  • Prior brand familiarity and habit formation

When does Allegra Allergy lose exclusivity, and what does that mean for long-term profitability?

What is the exclusivity reality for core fexofenadine products?

Fexofenadine was introduced well before current market dynamics. Core immediate-release and many line items moved into generic competition years ago, which typically means:

  • No meaningful legal pricing protection for immediate-release fexofenadine OTC packs
  • Ongoing reliance on formulation and brand-level differentiation rather than exclusivity for sustained higher margins

What does “lost exclusivity” do to financial trajectory?

  • Branded price increases become harder to sustain without losing volume
  • Gross margin is pressured because branded trade spend rises to defend share
  • Net sales become more sensitive to promotional intensity rather than to unit pricing

How many patents protect Allegra Allergy formulations, and what types matter commercially?

Patent estate relevance in an OTC small-molecule antihistamine

For a generic-dominated active ingredient like fexofenadine, the commercially relevant patent types usually narrow to:

  • Formulation patents for specific dosage forms (ODT/rapid-dissolve, distinct release profiles)
  • Method-of-manufacture patents tied to process controls
  • Method-of-use patents are less typical for OTC antihistamines at this stage
  • Device-related or packaging-related IP is possible but usually secondary in financial impact

What matters for business outcomes

Even if patents exist for specific line extensions, they tend to affect:

  • Whether the brand can premium-price a particular dosage form
  • Whether competitors can enter a niche product form without design-around

Core immediate-release demand is typically the volume driver, which is why overall profitability is still dominated by generic economics.

What generic entry risks exist for Allegra Allergy products?

Why generic risk is structurally high

For OTC fexofenadine, the generic entry risk is less about “will generics launch” and more about:

  • How quickly generics expand to additional package sizes and dosage forms
  • Whether generics can match brand-specific formulation and taste/mouthfeel characteristics
  • Whether the brand uses line extensions fast enough to preserve unit economics

What generic launches usually change

  • Immediate downshift in branded net price
  • Increased retailer willingness to switch store-brand or lower-cost offerings
  • Higher promotional pressure across the entire category to prevent share loss

How does Allegra compare with other allergy OTC franchises on financial durability?

Brand vs. generic “floor” economics

In mature OTC antihistamine markets, financial durability usually comes from:

  • Category leadership position at key accounts
  • A portfolio of formats that generics cannot fully replicate on consumer preference grounds
  • Lower reliance on premium pricing and faster adaptation to discounting

If another branded competitor retains stronger shelf differentiation (format or consumer habit), it can take a larger share of peak-season dollars.

Expected trajectory pattern for Allegra

The typical pattern is:

  • Stable or slowly declining unit share after core generics mature
  • Periodic net sales fluctuations tied to seasonal demand and promotion
  • Margin compression over time unless line extensions sustain a premium

What is the Orange Book status of fexofenadine products like Allegra?

Orange Book role for mature small molecules

The Orange Book is relevant for prescription equivalents and specific NDA label claims. For OTC antihistamines:

  • Many core products are long out of protected patent terms
  • Orange Book may show limited residual patent listings for specific formulations, if any are currently listed

For investors and litigators, the key business point remains: Orange Book listings rarely reverse the economics once generic competition is established across primary strengths.

What litigation or settlements affect Allegra Allergy economics?

Why litigation is less central than patent expiry

In mature OTC fexofenadine categories, litigation episodes can matter to launch timing, but the market is usually dominated by long-standing generics. That shifts the financial driver toward:

  • Broad retailer contracts and promotional planning
  • Product assortment strategy (format, pack size)
  • Seasonal execution

How do formulation line extensions impact Allegra’s market share and margins?

ODT and convenience-focused differentiation

Line extensions like dissolvable or convenience formats can:

  • Sustain higher net pricing on those SKUs
  • Reduce consumer switching if preferred formulation becomes a habit
  • Create temporary competitive asymmetry if generics lag in replicating consumer-preferred attributes

What happens when generics catch up on format

Once generics enter the same dosage form and packaging ecosystem:

  • Price convergence accelerates
  • Brand’s net sales growth usually depends on incremental share rather than premium pricing
  • Trade spend often rises to maintain planogram visibility

Where does Allegra monetize: channel mix and pack strategy?

Channel dynamics

OTC antihistamines generally distribute across:

  • Mass retail (high volume, price sensitive)
  • Pharmacy (more brand-focused, often higher trade economics)
  • E-commerce (search-driven substitution; ratings and bundling influence conversion)
  • Warehouse clubs (bulk pack economics)

Branded strategy typically optimizes:

  • Pack sizes aligned with seasonal stocking and consumer purchase cycles
  • Promotional mechanics that avoid training consumers to only buy on deep discounts

Financial trajectory summary: what to expect next for Allegra Allergy

Allegra’s future financial trajectory is likely to be:

  • Category-growth-linked with seasonality
  • Moderately pressured on price due to persistent generic competition
  • Dependent on maintaining share through OTC channel execution and any defensible line-extension SKUs

A sustainable outperformance scenario requires either (1) a meaningful consumer-preferred format where the brand holds differentiation longer than generic entrants, or (2) category expansion that outpaces dilution of branded pricing power.


Key Takeaways

  • Allegra Allergy’s commercial path is dominated by mature fexofenadine economics: generic penetration reduces branded pricing power and forces higher promotion to defend share.
  • Market dynamics are seasonal and channel-driven, with profitability tied to trade spend control and shelf/online visibility during allergy peaks.
  • Long-run financial durability depends more on OTC execution and format line extensions than on active exclusivity for core immediate-release products.
  • Generic entry risk is ongoing at the pack and formulation level, typically changing pricing faster than brand differentiation can offset.

FAQs

  1. Does Allegra’s ODT format change its competitive position versus generic fexofenadine?
  2. How does season length and weather variability impact Allegra Allergy monthly net sales?
  3. Which OTC allergy brands most influence fexofenadine demand during peak spring and fall?
  4. What commercial levers (trade spend, pack sizes, channel mix) most affect Allegra’s margins in a generic-saturated category?
  5. How do e-commerce substitution dynamics affect branded Allegra share when generics are cheaper on Amazon and retailer sites?

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
  2. FDA. Drug Trials Snapshots (drug product information and labeling references). U.S. Food and Drug Administration.
  3. IQVIA Institute for Human Data Science. OTC and consumer health market reporting (industry summaries).
  4. Public company filings (where available): annual and quarterly reports discussing OTC allergy category dynamics and promotional cost trends.

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