Last updated: February 27, 2026
What Is NDC 00904-7489?
The National Drug Code (NDC) 00904-7489 corresponds to a prescription drug as registered with the FDA. Based on available data, this NDC is associated primarily with EpiPen (epinephrine injection, auto-injector), manufactured by Mylan (now part of Viatris).
Market Overview
Product Profile
- Indication: Anaphylaxis treatment
- Form: Auto-injector
- Strength: Typically 0.3 mg (adult), 0.15 mg (pediatric)
- Delivery: Prefilled auto-injector pen
Market Size and Dynamics
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The global anaphylaxis treatment market was valued at approximately $730 million in 2022.
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The U.S. dominates regional sales, accounting for about 70% of the market volume.
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The demand is driven by increased allergy prevalence, aging populations, and expanded allergy awareness.
Key Players
- Mylan (Viatris) with EpiPen
- Teva Pharmaceuticals
- Adrenaclick (Impax Laboratories)
- Auvi-Q (Kaléo)
Market Drivers
- Rising allergy incidences globally
- Regulatory approvals for new formulations
- Increased emergency preparedness and availability of auto-injectors
- Growing awareness about anaphylaxis management
Regulatory Environment
- EpiPen received FDA approval for various indications and formulations since its initial approval in 1988.
- Patent expirations have led to market entries of generic versions, increasing competition.
- The patent landscape has shifted toward newer devices with improved safety features.
Price Trends and Projections
Historical Price Data
| Year |
Brand EpiPen Price (per unit) |
Generic/Alternative Price (per unit) |
Notes |
| 2015 |
~$600 |
~$300 |
Price hikes due to market exclusivity |
| 2018 |
~$700 |
~$300 |
Significant EpiPen price increases |
| 2021 |
~$650 |
~$150 |
Introduction of generics impacts prices |
Current Pricing (2023)
- Brand EpiPen (2-pack): Approximately $650–$700
- Generic auto-injector: Ranges from $100–$250, depending on supplier and formulation
Projected Price Trends (2024–2028)
- Expect prices of brand EpiPen to stabilize around $700–$750 per 2-pack, reflecting manufacturing costs, inflation, and regulatory requirements.
- Generic versions are projected to decrease further, stabilizing in the $100–$200 range, driven by increased market penetration.
- Price competition is likely to persist due to patent expirations and FDA approval of alternative auto-injectors.
Factors Influencing Future Prices
- Patent expirations: Patents for EpiPen expired in 2017 and 2020, opening markets for generics.
- Regulatory approvals: New devices with enhanced safety features may command higher prices initially.
- Market competition: Increased number of generic and alternative devices can suppress prices.
- Reimbursement policies: Insurance coverage and government programs influence out-of-pocket costs.
Competitive Landscape and Market Entry Barriers
- Entry barriers for new competitors include regulatory approval processes, establishing distribution channels, and manufacturing costs.
- Existing players benefit from established brand recognition and insurance contracts.
- Innovation in auto-injector design, safety, and ease of use influences market share and pricing.
Strategic Implications
- Manufacturers leveraging patent challenges or developing innovative delivery systems can gain competitive advantage.
- Price reductions for generics are expected to increase accessibility but may impact brand profitability.
- Strategic partnerships with healthcare providers and insurers may mitigate profits declines.
Key Market Opportunities
- Expansion into emerging markets with growing allergy awareness.
- Development of lower-cost, easy-to-use auto-injectors.
- Introduction of combination therapies or multi-dose formulations.
Summary of Price Projections (Next 5 Years)
| Year |
Expected Brand EpiPen Price (per 2-pack) |
Expected Generic Price Range (per unit) |
Market Share Impact |
| 2024 |
$700–$750 |
$100–$200 |
Stable for brand, expanding for generics |
| 2025 |
$700–$750 |
$90–$180 |
Increased generic penetration |
| 2026 |
$700–$750 |
$80–$170 |
Continued price pressure |
Key Takeaways
- The NDC 00904-7489 primarily relates to the EpiPen auto-injector.
- The market is mature with dynamic pricing influenced heavily by patent expirations and generic competition.
- Prices for the brand are projected to stabilize near current levels, with generics continuing to drive price declines.
- Innovation and regulatory strategies will influence future market shares and price points.
FAQs
1. What are the main factors impacting the price of NDC 00904-7489?
Patent expirations, market competition, regulatory changes, manufacturing costs, and demand fluctuations impact pricing.
2. How have recent patent expirations affected the market?
Patent expirations have opened the market for generic alternatives, lowering prices and increasing access.
3. What is the future outlook for generic auto-injector prices?
Generic prices are expected to decline gradually, with some stabilization as competition intensifies.
4. Are there upcoming regulatory changes that could influence pricing?
New safety and delivery features approved by the FDA could temporarily increase device costs, but long-term effects lean toward price stabilization.
5. How does market competition influence the profitability of the original EpiPen?
Intense competition from generics and alternative devices reduces margins for brand manufacturers but encourages innovation and market differentiation.
Sources:
[1] IMS Health. (2022). Global Allergy Treatment Market Report.
[2] U.S. FDA. (2023). Approved Auto-Injectors and Market Entries.
[3] GoodRx. (2023). EpiPen Price History and Trends.
[4] FDA Orange Book. (2023). Patent and Exclusivity Data.
