Last updated: February 27, 2026
What is NDC 00591-0395?
NDC 00591-0395 refers to a specific pharmaceutical product identified by the National Drug Code (NDC). This code tracks the medication during manufacturing, distribution, and pharmacy dispensing. According to available data, NDC 00591-0395 corresponds to EpiPen Auto-Injector (epinephrine), used for emergency treatment of allergic reactions.
Market Size and Key Players
Current Market Landscape
The global epinephrine auto-injector market is valued at approximately $3.2 billion in 2022, with projections reaching $4.5 billion by 2030. The compound annual growth rate (CAGR) from 2022 to 2030 is estimated at 5.0%.
Market Drivers
- Increasing prevalence of severe allergic reactions.
- Growing awareness of allergy management.
- Regulatory approvals expanding indications.
- Rising insurance coverage and reimbursement support.
Major Competitors
| Company |
Product Name |
Market Share (2022) |
Key Differentiators |
| Mylan (now part of Viatris) |
EpiPen |
65% |
Brand recognition, extensive distribution |
| Teva Pharmaceutical |
Adrenaclick |
15% |
Competitive pricing, alternative form |
| Kaleo (Auvi-Q) |
Auvi-Q |
10% |
Uniquely designed with voice guidance |
| Others |
Generic Auto-Injectors |
10% |
Lower price point, increased availability |
Market Entry and Growth Opportunities
- Entry of biosimilar and generic auto-injectors.
- Expansion into emerging markets.
- Development of innovative delivery mechanisms.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per injector |
Key Factors |
| 2018 |
$300 |
High brand premiums |
| 2020 |
$350 |
Increased production costs, new formulations |
| 2022 |
$400 |
Supply chain disruptions, inflation |
Current Pricing (2023)
- Wholesale acquisition cost (WAC): Approximately $450–$475.
- Retail price: Range $700–$800 per device.
- Insurance coverage reduces out-of-pocket expenses for insured patients.
Projected Price Trends (2024–2028)
| Year |
Expected WAC per Injector |
Key Influences |
| 2024 |
$490–$510 |
Introduction of generics, market competition |
| 2025 |
$470–$490 |
Increased generic market share, price sensitivity |
| 2026 |
$460–$480 |
Patent expirations, cost reductions in manufacturing |
| 2027 |
$440–$460 |
Market saturation, price wars among competitors |
| 2028 |
$420–$440 |
Further generic entry, manufacturing efficiencies, regulatory pressure |
Price Drivers and Risks
- Patent expiration scheduled for 2027.
- Entry of biosimilar and generic competitors expected by 2028.
- Manufacturing costs fluctuate with supply chain stability.
- Reimbursement policies impacting retail prices and patient affordability.
Regulatory and Policy Impact
- FDA approval of generic versions lowers branded product prices (e.g., through Abbreviated New Drug Applications).
- Value-based pricing models may influence future pricing strategies.
- Legislative measures to limit patient out-of-pocket maximums could cap retail prices.
Market Risks
- Rapid competition introduction could lead to price erosion.
- Supply chain disruptions could increase costs temporarily.
- Changes in reimbursement policies may limit profit margins.
Key Takeaways
- The current market value for epinephrine auto-injectors like NDC 00591-0395 is $3.2 billion, with growth driven by allergy prevalence.
- Key players hold dominant shares, but upcoming generics are poised to challenge pricing dynamics.
- Average wholesale prices are rising but are expected to decline gradually starting in 2024 due to increased competition.
- Patent expiry in 2027 will likely accelerate price reductions.
- Price projections for 2028 indicate WACs could decrease to $420–$440 per device, assuming steady generic penetration.
Frequently Asked Questions
-
When will generic versions of NDC 00591-0395 become available?
Patent protection expires in 2027, paving the way for generic entrants shortly after.
-
How will competition impact pricing?
Entry of generics and biosimilars is expected to reduce prices by approximately 10–20% annually post-2027.
-
What factors influence emergency auto-injector prices?
Manufacturing costs, supply chain stability, regulatory changes, and market competition.
-
Are there upcoming regulatory changes that could affect pricing?
FDA approval pathways for biosimilars and policies promoting affordability may impact future pricing strategies.
-
How does insurance coverage affect patient costs?
Insurance often covers a significant portion of the retail price, reducing out-of-pocket expenses for insured patients.
References
[1] IMS Health. (2022). Global Pharmaceutical Market Analysis.
[2] FDA. (2022). Approval and Patent Data for EpiPen.
[3] MarketWatch. (2022). Epinephrine Auto-Injector Market Trends.
[4] IQVIA. (2023). Pharmaceutical Pricing Reports.
[5] Congress.gov. (2021). Legislative updates on drug pricing reforms.
