Last updated: February 13, 2026
What is NDC 57841-1301?
NDC 57841-1301 corresponds to Ketamine Hydrochloride Injectable Solution, 50 mg/mL, produced by MHA Toronto IV Solutions. Marketed primarily for anesthesia, anesthesia adjunct, and pain management, this formulation gained attention amid rising interest in its off-label uses, notably for depression.
Market Environment Overview
Market Size and Demand Drivers
- The global anesthetic drugs market was valued at approximately USD 6.5 billion in 2022.
- The injectable ketamine segment accounts for a significant subset, driven by expanded use in psychiatric treatment and pain management.
- FDA and EMA approvals of Esketamine (Spravato) for treatment-resistant depression boost interest in ketamine-related therapies.
- The COVID-19 pandemic increased demand for anesthetic agents, including ketamine, for intensive care applications, though demand has normalized post-pandemic.
Key Market Segments
| Segment |
Share (2022) |
Growth Rate (2022-2027) |
Notes |
| Anesthesia induction drugs |
55% |
3.5% |
Primary use in operating rooms |
| Pain management (including intranasal and injectable) |
35% |
4.2% |
Includes off-label psychiatric use |
| Psychiatric therapy (off-label) |
10% |
15% |
Growing trend in depression treatment |
Competitive Landscape
- Market dominated by established generic manufacturers, including Hikma, APP Pharmaceuticals, and Mylan.
- Limited branded competition outside of specialty treatments like Esketamine.
- Recent entry of compounded and "off-label" formulations has increased supply variability.
Regulatory and Policy Impact
- U.S. FDA approved Esketamine (Spravato) in 2019 for depression, influencing demand patterns.
- The Department of Veterans Affairs actively incorporates ketamine into pain and depression protocols.
- State-level DEA regulations on Schedule III substances influence distribution and pricing.
- COVID-19 supply chain disruptions affected raw material availability, temporarily impacting pricing.
Pricing Analysis
Historical Pricing Trends
| Year |
Price per mL (USD) |
Notes |
| 2018 |
$3.50 |
Standard generic injectable price |
| 2020 |
$6.00 |
Pricing increase amid supply constraints |
| 2022 |
$7.50 |
Stable, with some regional variation |
| 2023 |
$8.00 |
Slight increase, reflecting inflation and supply chain costs |
Current Price Range (2023)
- Retail hospital and pharmacy price approximates USD 8.00–10.00 per mL.
- Contract prices for hospitals and clinics range from USD 5.50 to USD 7.50 per mL.
- Off-label compounded formulations may be priced lower or higher depending on customization and compounding costs.
Comparison to Similar Agents
| Drug |
Price per mL |
Use Case |
Regulatory Status |
| Esketamine (Spravato) |
USD 590 per spray (optional nasal spray) |
Depression treatment |
FDA-approved, branded |
| Racemic ketamine |
USD 4–10 |
Anesthesia, off-label depression |
Off-label, generic formulation |
Price Projections (2024-2028)
- Expect gradual increases aligned with inflation.
- Supply chain stabilizations may mitigate rapid price increases.
- Growth in psychiatric off-label use may expand demand, supporting prices in the USD 8.50–11.00 per mL range by 2028.
- Competition from compounded preparations could pressure costs downward in specific markets.
Key Factors Influencing Future Pricing
- Regulatory Developments: Any new approvals for ketamine formulations driven by clinical trials can alter demand.
- Generic Competition: Increasing manufacturing capacity among generic producers could flatten or reduce prices.
- Reimbursement Policies: Coverage expansion into mental health treatments from payers may boost demand.
- Supply Chain Stability: Raw material costs and manufacturing capacity will influence prices, especially amidst global disruptions.
Key Market Opportunities and Risks
Opportunities
- Growing acceptance of ketamine for depression and chronic pain.
- Expansion into outpatient and telehealth markets.
- Potential FDA approval of new indications could elevate demand.
Risks
- Regulatory restrictions, including DEA scheduling changes.
- Intense price competition among generic manufacturers.
- Potential patent or exclusivity claims on new formulations.
Summary of Price Forecast Metrics
| Year |
Estimated Price Range (USD per mL) |
Comments |
| 2023 |
$8.00–10.00 |
Current market range |
| 2024 |
$8.50–11.00 |
Gradual upward trend |
| 2025 |
$9.00–12.00 |
Increased demand, stable supply |
| 2026 |
$9.50–13.00 |
Continued growth in psychiatric uses |
| 2027 |
$10.00–13.50 |
Market saturation, competition intensifies |
| 2028 |
$10.50–14.00 |
Larger adoption in mental health, stabilized pricing |
Key Takeaways
- The market for injectable ketamine (NDC 57841-1301) remains sizable and evolving, driven by clinical expansion into depression and pain management.
- Prices have stabilized at around USD 8.00–10.00 per mL in 2023, with projections for modest increases over the next five years.
- Competition from generics and compounded formulations could influence price levels.
- Regulatory and policy shifts, especially related to mental health indications, will be primary catalysts for market growth or contraction.
FAQs
1. How is the demand for NDC 57841-1301 expected to change?
Demand is anticipated to grow modestly, primarily driven by increased off-label use in depression and pain management, coupled with expanding reimbursement policies.
2. What factors could lead to price decreases?
Introduction of new generics, supply chain alleviation, or stricter regulatory restrictions could decrease prices.
3. How does NDC 57841-1301 compare to branded ketamine treatments?
Generic injectable solutions like NDC 57841-1301 typically cost significantly less than branded or specialty formulations such as Esketamine, which can cost hundreds of dollars per dose.
4. What regulatory developments could impact the market?
Any reclassification or scheduling adjustments by the DEA, or new FDA approvals for ketamine-based therapies, could influence supply and demand.
5. Are there geographical differences in pricing?
Yes. Prices vary by region, influenced by local regulations, insurance coverage, and supply chain logistics.
Sources:
[1] MarketsandMarkets, "Anesthetic Drugs Market," 2022.
[2] IQVIA, "Pharmaceutical Pricing Trends," 2023.
[3] FDA, "Esketamine (Spravato) Approval Details," 2019.
[4] ReportLinker, "Ketamine Market Overview," 2023.
[5] U.S. DEA, "Regulations on Schedule III Substances," 2022.
