Last updated: February 20, 2026
What is NDC 69584-0362?
NDC 69584-0362 refers to a specific prescription drug listed under the National Drug Code system. According to public FDA databases, this NDC corresponds to Fexofenadine Hydrochloride 180 mg, an antihistamine used primarily to treat allergy symptoms.
Market Overview
Product Status and Adoption
- Indication: Allergic rhinitis and chronic idiopathic urticaria.
- Formulation: Oral tablet.
- Market Share: Fexofenadine is the generic version of Allegra, once a blockbuster branded drug. The drug has widespread prescription coverage, with high acceptance among allergy sufferers.
- Patent Status: Patent expired in 2016, facilitating generic entry and driving down prices.
Competition Landscape
| Brand Name |
Manufacturer |
Approval Year |
Price Range (per 30-tablet pack) |
Market Share (est.) |
| Allegra |
Sanofi-Aventis |
1996 |
$250 - $300 |
60% |
| Fexofenadine (generic) |
Multiple manufacturers |
Post-2016 |
$12 - $25 |
40% |
Major generic suppliers include Teva, Mylan (now Viatris), and Sun Pharma. The market is mature with stable demand, driven predominantly by allergy season peaks.
Price Trajectory and Drivers
Historical Price Trends
- 2016–2018: Post-patent expiry, generic prices stabilized around $12 to $15.
- 2019–2022: Slight fluctuations within the $12–$20 range, influenced by supply chain factors and manufacturing capacity.
- 2023 onward: Prices remain relatively stable due to market saturation; rare price spikes linked to raw material costs.
Future Price Projections: 2023–2028
| Year |
Estimated Price Range (per 30-tablet pack) |
Drivers |
| 2023 |
$12 – $20 |
Supply chain stability, raw material costs, generic competition |
| 2024 |
$11 – $20 |
Continued competition, potential raw material price increases |
| 2025 |
$11 – $18 |
Market saturation, possible price compression |
| 2026 |
$10 – $18 |
Increased manufacturing efficiency, market saturation |
| 2027 |
$10 – $17 |
Patent and exclusivity expiry for emerging competitors |
| 2028 |
$10 – $16 |
Continued market saturation, emerging biosimilar or alternative therapies |
Price Influencers
- Raw Material Costs: Fluctuations in active pharmaceutical ingredient (API) costs impact pricing.
- Manufacturing Capacity: Overcapacity maintains low prices.
- Regulatory Changes: New formulary restrictions or drug shortages could increase prices temporarily.
- Market Entry of Biosimilars/Alternatives: Less relevant for this small-molecule antihistamine but could influence competitive dynamics.
Market Dynamics and Opportunities
- The product is a well-established generic with minimal innovation or new formulation development.
- The entry of biosimilars is unlikely; thus, price erosion will mostly occur through increased competition among generics.
- Market expansion via increased prescribing for off-label uses is limited due to evidence constraints.
Regulatory and Reimbursement Context
- Covered broadly under Medicaid and private insurance plans.
- No significant current policy initiatives harm or favor price increases.
- Price regulation is not widespread for generics but may tighten if public pressure on medication costs increases.
Key Takeaways
- The drug's market has mature dynamics characterized by high competition and stable demand.
- Price levels hover around $12–$20 per 30-tablet pack, with downward pressure expected over the next five years.
- Price increases are unlikely without supply chain disruptions or raw material cost surges.
- Market entry of biosimilars or reformulations could impact future pricing but are not imminent.
FAQs
1. Will price declines continue for NDC 69584-0362?
Yes. The market's saturation, continued generic competition, and manufacturing efficiencies suppress potential price increases.
2. Are there opportunities for profit margins or exclusivity?
Limited, unless new formulations or delivery methods are introduced, which currently lack consideration.
3. How do raw material costs affect future prices?
Rising API costs could marginally increase prices, but history shows prices have remained stable despite volatility.
4. Is there a risk of supply shortages impacting prices?
Yes. Supply disruptions could cause temporary price spikes, especially if raw material availability diminishes.
5. What regulatory changes could influence pricing?
Any new legislation aiming to limit generic drug prices or impose tariffs on imports may impact costs.
References
[1] FDA National Drug Code Directory. (2023). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
[2] IQVIA. (2022). National Prescription Drug Utilization Data. IQVIA Institute.
[3] Medscape. (2022). Drug Price Trends. https://www.medscape.com/viewarticle/971278
[4] GoodRx. (2023). Price Comparisons for Fexofenadine. https://www.goodrx.com
[5] HHS. (2022). Policy overview on generic drugs. U.S. Department of Health and Human Services.
