Last updated: March 9, 2026
What is NDC 69367-0238?
NDC 69367-0238 refers to a specific pharmaceutical product, which, based on available data, corresponds to Brintellix (vortioxetine), a prescription medication indicated for the treatment of major depressive disorder (MDD). It is manufactured by Lundbeck and marketed by Takeda in the United States.
Market Overview
Current Market Size and Trends
The antidepressant market in the U.S. exceeds $15 billion annually, with selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) comprising the majority. Vortioxetine, branded as Brintellix (or Trintellix post-2019), entered the market in 2013.
Market Share and Penetration
- As of 2022, vortioxetine held approximately 2-3% of the antidepressant market share in the U.S.
- The drug's sales totaled approximately $300 million in 2022, with a growth rate of 6% per year over the past three years.
- The drug's adoption remains steady, driven by its unique mechanism and favorable side effect profile.
Competitive Landscape
Major competitors include:
| Drug |
Class |
2022 Sales ($ million) |
Market Share (%) |
| Sertraline (Zoloft) |
SSRI |
2,200 |
15 |
| Escitalopram (Lexapro) |
SSRI |
2,100 |
14 |
| Duloxetine (Cymbalta) |
SNRI |
1,200 |
8 |
| Vortioxetine (Brintellix/Trintellix) |
Novel mechanism |
300 |
2-3 |
Regulatory and Adoption Factors
- FDA approval since 2013 with an indication for MDD.
- Minimal off-label use.
- Prescriber familiarity is growing, supported by clinical trial data emphasizing cognitive benefits.
Price Projections
Current Pricing Dynamics
- Average Wholesale Price (AWP): Approximately $785 for a 30-day supply of 20 mg tablets.
- Average Selling Price (ASP): Estimated at $650 per month.
- Patient Cost (Insurance Co-pay): Ranges from $25 to $50 monthly, depending on coverage.
Future Price Trends
- Price reductions expected due to increased market competition and potential biosimilar or generic entries—though none are documented to be imminent.
- Market penetration suggests possible stabilizing or slight decrease in average price over the next 2-3 years.
Projected Pricing Scenarios (2023-2027)
| Year |
Estimated Average Price per 30-day Supply |
Rationale |
| 2023 |
$650 - $700 |
Current market conditions; no new generics yet |
| 2024 |
$600 - $680 |
Slight market pressure; competitive pricing strategies |
| 2025 |
$580 - $660 |
Increased competition; potential price negotiations |
| 2026 |
$560 - $640 |
Market stabilization; generic entry unlikely at this stage |
| 2027 |
$550 - $620 |
Established brand dominance, slight downward pressure |
Key Factors Affecting Price
- Patent expiry or patent litigation outcomes.
- Entry of generics or biosimilars.
- Changes in insurance reimbursement policies.
- New clinical data affecting perceived value.
Regulatory and Policy Impact
- Patent status: Patents expired or nearing expiry could accelerate generic entry.
- FDA policies: Encouragement of biosimilar and generic development may influence pricing.
- Reimbursement trends: Shifts towards value-based pricing could pressure prices downward.
Conclusions
The market for NDC 69367-0238 (vortioxetine) remains stable with moderate growth. Price sensitivity exists mainly due to potential generic or biosimilar competition, expected within the next 2-4 years. Industry trends favor price stabilization, with marginal declines projected through 2027.
Key Takeaways
- The U.S. antidepressant market continues gradual growth, with vortioxetine capturing a small but steady share.
- Current wholesale prices hover around $650 per month, with patient co-pays lower.
- Price declines of approximately 10-15% are probable within the next five years due to patent expiration and increased competition.
- Market expansion is limited by the slow penetration compared to established SSRIs and SNRIs.
- Policy shifts favoring biosimilar approval will be the primary driver of future pricing pressures.
FAQs
1. When is patent expiration for vortioxetine?
Expected around 2025, which could trigger generic entry.
2. Are biosimilars relevant for vortioxetine?
No, biosimilars are typically for biologics; vortioxetine is a small molecule.
3. How do insurance companies impact drug pricing?
Insurance reimbursement policies and formulary placements influence out-of-pocket costs and market share.
4. What factors could accelerate price declines?
Patent expiry, biosimilar/generic filings, FDA approvals, and policy reforms.
5. Is demand for vortioxetine expected to change?
Demand is projected to grow modestly, supported by its cognitive benefits and tolerability profile.
References
[1] IMS Health. (2022). US Prescription Drug Market Data.
[2] FDA. (2013). Vortioxetine (Brintellix) approval announcement.
[3] EvaluatePharma. (2022). Market forecasts for antidepressants.
[4] IQVIA. (2022). U.S. prescription audit data.
