Last updated: February 27, 2026
What is NDC 00536-1319?
NDC 00536-1319 corresponds to Narcan (naloxone) nasal spray. It is an opioid antagonist used to treat opioid overdoses. Approved by the FDA in 2015, Narcan has become critical in addressing the opioid crisis. The drug is available in multiple formulations, primarily as a nasal spray, with generic options entering the market since 2021.
Market Size and Segmentation
Current Market Overview
The naloxone market has seen significant growth driven by governmental policies, increased awareness, and opioid overdose rates. As of 2022, the global opioid overdose treatment market was valued at approximately USD 2 billion. Narcan is a dominant player within this space.
Key Market Segments
- Prescriptions: Narcan is widely prescribed for opioid overdose management, especially in emergency settings and community distribution programs.
- Over-the-counter (OTC) availability: In 2023, the FDA approved an OTC formulation of Narcan, aiming to expand access.
Market Drivers
- Rising opioid overdose deaths, with over 80,000 reported in the U.S. in 2020.
- Legislative efforts mandating naloxone availability in public spaces and for at-risk populations.
- Increased insurance coverage and government subsidies.
Market Constraints
- Competition from generic naloxone nasal sprays and injectable formulations.
- Pricing concerns from payers and policymakers influencing market penetration.
Pricing Trends and Projections
Historical Pricing
| Year |
Narcan (Brand) Price per Kit |
Generic Price per Kit |
Notes |
| 2015 |
USD 125 |
N/A |
Launch price for Narcan nasal spray |
| 2018 |
USD 125–150 |
USD 80–100 |
Slight increases due to demand |
| 2021 |
USD 125–150 |
USD 70–90 |
Generic versions introduced |
Recent Price Developments
Post-approval of OTC formulations, prices have shown variability:
- OTC Narcan (generic): USD 44–45 per kit (as of 2023).
- Brand Narcan (prescription): USD 125–150 per kit in pharmacies.
- Medicaid and insurance discounts have reduced out-of-pocket costs for some populations.
Price Projections (2023–2028)
Assuming increased generic competition and expanded OTC access, prices are expected to decline:
| Year |
Estimated Brand Price per Kit |
Estimated Generic Price per Kit |
Key Factors |
| 2023 |
USD 125–150 |
USD 44–50 |
OTC market expansion |
| 2024 |
USD 115–135 |
USD 40–45 |
Increased generic adoption |
| 2025 |
USD 105–125 |
USD 35–40 |
Generic market saturation |
| 2026 |
USD 95–115 |
USD 30–35 |
Policy efforts to lower costs |
| 2027 |
USD 85–105 |
USD 25–30 |
More OTC options and subsidies |
| 2028 |
USD 75–95 |
USD 20–25 |
Price stabilization |
Market Dynamics
The growth in OTC availability is a key driver reducing prices over the long term. Payer negotiations and government programs are expected to further drive down costs, expanding access among underserved populations.
Competitive Landscape
- Brand: Narcan (adapted by Biotech firms)
- Generics: Multiple manufacturers producing naloxone nasal spray, expected to grow market share.
- Injectable formulations: Appear as substitutes but hold smaller market segments.
Regulatory and Policy Impact
- FDA approvals of OTC formulations for OTC use in 2023 increase distribution channels.
- State and federal mandates incentivize free or low-cost distribution, pressuring retail prices downward.
- Reimbursement policy developments, including Medicaid expansion, affect affordability.
Key Takeaways
- The market for naloxone, especially NDC 00536-1319, is growing due to the opioid epidemic.
- Prices are decreasing, driven by OTC formulations and generic competition.
- Total market size remains significant, with projections indicating steady growth through 2028.
- Price reductions are anticipated as policy and market conditions favor broader access.
FAQs
-
What factors influence the price of Narcan?
Market competition, regulatory approvals, government subsidies, and manufacturing costs.
-
How does generic competition affect pricing?
Increased generic options typically lead to price reductions due to competition.
-
What policies are affecting the naloxone market?
Mandates for naloxone availability, OTC approvals, and Medicaid expansion lower costs.
-
Is OTC access expected to grow?
Yes; regulatory approvals have led to increased OTC availability, lowering barriers.
-
What is the future outlook for Narcan prices?
Long-term decline expected due to generics and increased OTC access, stabilizing around USD 20–30 per kit in a few years.
References
[1] U.S. Food and Drug Administration. (2023). FDA approves first OTC naloxone nasal spray.
[2] MarketWatch. (2022). Global opioid overdose treatment market size and forecast.
[3] IMS Health. (2021). Naloxone market dynamics.
[4] CDC. (2020). Opioid overdose statistics.
[5] Medicare & Medicaid Services. (2023). Pricing and coverage policies.
