Last updated: February 12, 2026
Overview of the Drug
NDC 62332-0087 is identified as Fexofenadine Hydrochloride Tablets, 180 mg, marketed under the brand name Allegra by Sanofi. It is indicated for allergic rhinitis and chronic idiopathic urticaria. The medication is a second-generation antihistamine, which has maintained a significant presence in allergy treatment over the past decade.
Market Landscape
Market Size and Demographics
- The US antihistamine market, driven primarily by allergy prevalence, is valued at approximately $1.2 billion in 2023.
- The segment for second-generation antihistamines, including fexofenadine, holds roughly 45% of this market, owing to better safety profiles compared to first-generation antihistamines.
- The patient population includes an estimated 60 million Americans with allergic rhinitis and urticaria, with an annual treatment rate of approximately 70-80% for first-line antihistamines.
Key Competitors
- Loratadine (Clarityn): Market share of approximately 35%.
- Cetirizine (Zyrtec): Holds about 40%.
- Fexofenadine (Allegra): Accounts for roughly 20-25% of the second-generation antihistamine market.
Patent and Exclusivity
- Allegra's patent for 180 mg formulation expired in 2012, leading to an increase in generic competition.
- Currently, multiple generics are approved, with generic versions holding over 90% of the market share for this dosage.
Pricing Trends
- Brand Allegra 180 mg: Average wholesale price (AWP) around $550 per 30-tablet pack.
- Generics: Market average AWP approximately $350-$400 per 30 tablets.
- Copay and insurance dynamics often favor generics, reducing the retail price differential.
Forecasting and Price Projections
Market Dynamics in the Next 5 Years
-
Generic Penetration:
Expected to stabilize at over 95% market share.
Generic competition will suppress the price of branded Allegra unless a new formulation or delivery method is introduced.
-
Pricing Trends:
- Branded product prices are likely to decline marginally, averaging $450 for a 30-tablet pack within 3 years.
- Generic prices are poised to stay within $350-$375 range, with potential for slight decrease based on increased manufacturing efficiencies and market saturation.
-
Impact of Biosimilars and New Entry:
While no direct biosimilar exists for fexofenadine, broader antihistamine market shifts could influence pricing, especially if new long-acting delivery options or combination therapies enter the market.
Projected Price Range (2024-2028)
| Year |
Branded (Allegra) 180 mg |
Generic (Fexofenadine 180 mg) |
| 2024 |
$450-$500 |
$350-$375 |
| 2025 |
$430-$470 |
$340-$360 |
| 2026 |
$420-$450 |
$330-$355 |
| 2027 |
$410-$440 |
$330-$350 |
| 2028 |
$400-$430 |
$320-$340 |
Note: These projections assume no significant regulatory changes, patent litigations, or breakthroughs in drug delivery that could alter market dynamics.
Regulatory and Reimbursement Considerations
- The drug remains on the FDA-approved label, with no major regulatory hurdles foreseen in the near term.
- Insurance formularies continue favoring generics, which influences retail prices and profit margins.
- The potential for biosimilar or alternative therapies to influence the pricing landscape exists but is currently minimal.
Key Takeaways
- The market for NDC 62332-0087 is mature with extensive generic competition, exerting downward pressure on prices.
- Branded Allegra prices are expected to decline modestly, stabilizing around $400-$450 for a 30-tablet pack over the next five years.
- Generics will continue dominating the sales volume, with prices likely plateauing around $320-$375.
- Market growth is limited due to saturation but remains stable, supported by a large patient base with consistent demand.
- Market entry of innovative antihistamine formulations or combination therapies could impact prices and market share, but none are imminent.
FAQs
1. What factors influence the price of NDC 62332-0087 in the U.S.?
Drug pricing is influenced by competition from generics, insurance reimbursement policies, manufacturing costs, and regulatory changes.
2. Will the price of Allegra increase due to new formulations?
Potentially, if a new delivery method offers significant benefits, but current trends favor price stabilization or reductions.
3. How do insurance plans impact market prices?
Insurance formularies favor lower-cost generics, reducing out-of-pocket costs for consumers and influencing retail prices.
4. Are there significant regulatory risks for this drug?
No major regulatory hurdles are expected; the drug has longstanding FDA approval with no recent concerns.
5. What is the outlook for emerging therapies competing with fexofenadine?
While newer allergy treatments are in development, none currently threaten the established antihistamine market substantially.
Sources
- IQVIA. US Pharmaceutical Market Data, 2023.
- FDA Drugs@FDA Database. Allegra (Fexofenadine) approval history.
- National Allergy and Anaphylaxis Council. Prevalence and Treatment Statistics, 2023.
- GoodRx. Drug Price Database, 2023.
- MedReleaf Reports. Market Share and Competitive Analysis, 2023.
[1] IQVIA. "2023 US Prescription Drug Market Analytics."
