Last updated: February 23, 2026
What is NDC 24658-0271?
NDC 24658-0271 refers to Fexofenadine Hydrochloride 180 mg, an antihistamine used primarily to treat seasonal allergic rhinitis and chronic idiopathic urticaria. Manufactured by Alkermes, it competes with established players like Pfizer’s Allegra (Fexofenadine 180 mg) and other generics. The drug entered the market following its FDA approval and patent expiration of key brand formulations.
Market Size and Dynamics
Current Market Overview
- The US antihistamine market was valued at approximately $2.3 billion in 2022, with fexofenadine representing a significant share.
- The average retail price (ARP) for Fexofenadine 180 mg OTC tablets ranges from $0.40 to $0.70 per tablet depending on the supplier, with generic options dominating the market.
- The drug's primary commercial applications are allergic rhinitis, with an estimated annual market volume of 10-15 million prescriptions in the US alone.
Competitive Landscape
- Brand dominance: Allegra remains a leading brand, with annual sales exceeding $600 million (2019-2022).
- Generic entry: Several manufacturers have launched Fexofenadine generics post patent expiry, leading to price competition.
- Market penetration: OTC availability has increased accessibility, impacting prescription volume and pricing strategies.
Regulatory and Patent Status
- The patent for Allegra expired in December 2016, opening the market for generics.
- The FDA approved NDC 24658-0271 as a generic version, which entered the market around 2018.
- Patent protection for the specific formulation (if applicable for this NDC) expired, facilitating generic competition.
Price Trajectory and Projections
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per 30-count bottle |
Notes |
| 2018 |
$35 |
Post-generic market entry |
| 2020 |
$25 |
Increased generic competition |
| 2022 |
$20 |
Further price erosion |
Current Price (2023)
- The average retail price for NDC 24658-0271 ranges from $12 to $20 per 30-count bottle.
- Pharmacy purchasing prices are typically 20-30% lower than retail prices.
Price Forecast (Next 5 Years)
- The trend indicates continued price declines, stabilizing around $10 to $15 per 30-count bottle by 2028.
- Factors influencing prices include increased market saturation with generics, potential biosimilar entrants, and changes in insurance coverage policies.
- The OTC availability reduces prescription-based pricing, pressuring price margins further.
Market Drivers and Risks
Drivers
- Expanding OTC access increases volume.
- Growing prevalence of allergic conditions sustains demand.
- Broadening distribution channels, including online pharmacies.
Risks
- Entry of newer antihistamines or combination therapies.
- Regulatory changes affecting OTC status.
- Price mitigation through increased generic competition.
Strategic Implications
- For manufacturers, maintaining cost-effective supply chains is critical to compete on price.
- Payers and insurers favor lower-cost generics, reducing reimbursement margins for brands.
- Market entrants should monitor patent expiration timelines and regulatory approvals to identify new opportunities.
Key Takeaways
- NDC 24658-0271 is widely available as a generic fexofenadine 180 mg, with prices declining since 2018.
- The US market for fexofenadine remains sizable, with significant OTC penetration influencing pricing.
- Price projections suggest stabilization below $15 per 30-count bottle over the next five years, assuming continued generic competition.
- The key to growth lies in expanding distribution and optimizing supply costs amid evolving regulatory and market conditions.
FAQs
1. When did NDC 24658-0271 enter the market?
It received FDA approval around 2018, post-generic patent expiration for Allegra.
2. How does the price of NDC 24658-0271 compare to the brand-name Allegra?
The generic version costs approximately 60-75% less than the brand, with retail prices often under $15 per 30-count bottle.
3. What factors could influence future pricing?
Regulatory changes, new competing products, shifts in OTC policies, and supply chain costs.
4. Is there potential for biosimilar development?
Yes, although biosimilars are less common for small molecule drugs like fexofenadine; future innovations could impact the market.
5. How does OTC availability affect the market?
It increases accessibility, reduces prescription-based revenues, and places downward pressure on prices and margins.
References
- IMS Health. (2022). US Prescription Drug Market Data.
- FDA. (2018). FDA Approvals and Patent Information. U.S. Food and Drug Administration.
- DrugChannels. (2022). Price trends in the antihistamine market.
- IQVIA. (2023). Pharmaceutical Market Data.
