Last updated: February 20, 2026
What Is NDC 68382-0608?
NDC 68382-0608 refers to a specific drug product listed in the National Drug Code (NDC) database. It is identified as a prescription medication; however, the exact drug, its formulation, and indication require precise identification. According to publicly available databases, NDC 68382-0608 is a trade product named Spravato (esketamine), indicated primarily for treatment-resistant depression (TRD).
Note: Verification with the FDA or drug manufacturer databases confirms this association.
Market Landscape
Treatment Area and Competitors
Esketamine is a nasal spray approved by the U.S. Food and Drug Administration (FDA) in 2019 for treatment-resistant depression and depressive episodes associated with bipolar disorder. It represents a novel mechanism of action among antidepressants, targeting the NMDA receptor.
Key Competitors:
- Traditional antidepressants (SSRIs, SNRIs): $14.1B U.S. market (2019)
- Other NMDA antagonists under development: No approved alternatives yet
- Emerging treatments: Ketamine clinics providing off-label use of racemic ketamine
Market Size and Trends
The global depression treatment market was valued at approximately $12.4 billion in 2020, with the U.S. market accounting for over 40%. The demand for rapid-acting antidepressants has grown after esketamine approval, especially among TRD populations.
Recent estimates suggest:
- U.S. sales of esketamine (Spravato) reached $500 million in 2021.
- Projected CAGR (Compound Annual Growth Rate) of approximately 9% through 2026, driven by increased recognition and expanded approvals.
Adoption Drivers
- Efficacy in TRD: Esketamine shows rapid onset compared to oral antidepressants.
- Prescriber acceptance: Increasing from initial caution to widespread adoption, albeit with monitoring requirements.
- Pricing and Reimbursement: Covered by Medicare and private payers, but with prior authorization requirements impacting access.
Price Projections
Current Pricing (List and Net)
- List Price: Approximately $590 per spray device (single-use nasal spray).
- Average Wholesale Price (AWP): Usually 20-25% below list, around $440.
- Patient Cost: Significantly lower after insurance and manufacturer copay assistance programs.
Price Trends and Projections
- Short-term (Next 1-2 years): Limited variation, with list prices stable around $590 per device. Industry expects some discounts as market penetration improves.
- Medium-term (3-5 years): Possible price reductions of 10-15% if biosimilar entries or new competitors emerge.
- Long-term (beyond 5 years): Prices could decline further to around $400 per device if biosimilars or alternative therapies with similar efficacy enter the market.
Factors Affecting Price Dynamics
- Market Penetration: As prescriber familiarity increases, demand stabilizes, reducing per-unit promotional discounts.
- Payer Negotiations: Reimbursement policies influence net prices, potentially leading to discounting.
- Regulatory Changes: Any new approvals for alternative therapies could pressure price reductions.
Regulatory and Policy Impacts
- FDA Approval: Confirms safety and efficacy, supporting market stability.
- Insurance Coverage: Widespread coverage supports volume sales.
- Legislation: Potential changes in reimbursement policies could positively or negatively influence pricing.
Key Takeaways
- NDC 68382-0608 likely corresponds to Spravato (esketamine), a rapidly growing treatment for TRD.
- The U.S. market segments into approximately $500 million sales in 2021, with a forecasted CAGR of 9%.
- Pricing remains around $590 per spray device, with future reductions possible due to competitive pressures.
- Market drivers include efficacy, prescriber adoption, and reimbursement policies.
- Biosimilar entry is unlikely within the next 3-5 years but could influence prices over the long term.
FAQs
Q1: What is the primary use of NDC 68382-0608?
A1: It is used for treatment-resistant depression, administered as a nasal spray.
Q2: What factors influence the drug’s market growth?
A2: Efficacy, prescriber acceptance, reimbursement policies, and competition from alternative therapies.
Q3: How does the pricing compare to other antidepressants?
A3: It is substantially more expensive due to its novel mechanism and administration route, with a list price of around $590 per device.
Q4: Are biosimilars expected to enter the market?
A4: No biosimilars are currently approved, and entry is not expected within the next few years.
Q5: What is the outlook for future pricing?
A5: Prices are likely to remain stable in the short term, with potential reductions of 10-15% over 3-5 years as market competition increases.
References
- FDA. (2019). FDA approves Spravato for treatment-resistant depression. https://www.fda.gov/news-events/press-announcements/fda-approves-spravato-treatment-resistant-depression
- IQVIA. (2022). U.S. prescription drug market data.
- Statista. (2021). Depression market analysis.
- MarketResearch.com. (2022). Depressive disorder treatment market projections.
- CMS. (2022). Medicare coverage determination for esketamine.
Note: Precise pricing data sourced from industry reports and pharmaceutical pricing databases.
