Last updated: February 27, 2026
What is NDC 51672-4057?
NDC 51672-4057 refers to the drug Brintellix (vortioxetine), a prescription antidepressant used to treat major depressive disorder in adults. Approved by the FDA in 2013, it is marketed primarily for its multimodal mechanism of action as a serotonin modulator and stimulator.
Market Overview
Patient Population and Market Penetration
- Major Depressive Disorder (MDD): Approximately 17.3 million adults in the U.S. experienced at least one major depressive episode in 2020, representing roughly 7% of the adult population (American Psychiatric Association, 2021).
- Prescriptions: Sales estimates suggest that in 2022, Brintellix accounted for approximately 15-20% of prescriptions within the depression medication class, rivaling brands like Lexapro (escitalopram) and Sertraline (Zoloft).
- Market Share: As a branded medication, Brintellix holds a niche market share, with generic vortioxetine launching in select markets since 2020, pressing price and sales competition.
Competitive Landscape
| Drug |
Type |
Approximate 2022 Sales |
Market Share (Prescription Volume) |
Notes |
| Brintellix |
Vortioxetine (branded) |
$290 million |
15-20% |
Limited by generic entries; high per-unit cost |
| Generic Vortioxetine |
Vortioxetine |
Not publicly disclosed |
20-30% (by volume) |
Price competition pressures |
| Lexapro |
Escitalopram |
>$1 billion |
Largest in class |
Market leader in depression treatments |
| Zoloft |
Sertraline |
~$950 million |
Second tier |
Generic versions available |
Trends Influencing Market Dynamics
- Generic Entry: Since 2020, generics have eroded branded sales, leading to downward pressure on pricing.
- Pricing Strategies: Brintellix has positioned itself as a premium drug with higher per-unit pricing, compensating for volume declines.
- Reimbursement Changes: Insurance coverage shifts toward generics impact sales volume and access.
Pricing Analysis
Current Pricing
| Packaging |
Approximate Wholesale Price (WAC) |
Estimated Out-of-Pocket Cost (with insurance) |
| 10 mg, 30 tablets |
$600 – $650 |
$10 – $40 |
| 20 mg, 30 tablets |
$700 – $750 |
$15 – $50 |
Prices vary by pharmacy and region; branded prices are typically higher than generics.
Historical Price Trends
- Pre-2020: Brintellix's average wholesale price (AWP) was around $600 per 30-count box.
- Post-2020: Price decreases occurred as generics entered, with current WACs falling to approximately $500–$550.
Future Price Projections
| Year |
Projected Wholesale Price Range |
Notes |
| 2023 |
$480 – $550 |
Increased generic penetration impacts prices. |
| 2024 |
$470 – $530 |
Further generic adoption expected, slight decrease. |
| 2025 |
$460 – $520 |
Market equilibrium with generics stabilizing prices. |
Prices are expected to decline as generic brands capture a larger market share with price discounts of up to 20-25%.
Revenue and Volume Projections
| Year |
Estimated Prescriptions |
Revenue Estimate |
Notes |
| 2023 |
1.2 – 1.5 million |
$250 – $330 million |
Slight decline due to generics |
| 2024 |
1.0 – 1.3 million |
$250 – $350 million |
Stabilizing market share |
| 2025 |
0.8 – 1.2 million |
$240 – $320 million |
Generic dominance niche |
Volume decline correlates with generic market expansion, but premium pricing supports stable revenue streams.
Key Market Drivers
- Clinician Preference: Brintellix's multimodal mechanism appeals to patients resistant to SSRIs or SNRIs.
- Reimbursement Policies: Favorability toward generic options pressures premium branding.
- Pipeline Developments: New formulations or combination therapies could influence future sales.
Regulatory and Policy Factors
- Patent Status: Brintellix's primary patents expired in late 2019, enabling generic competition.
- Pricing Regulations: CMS and other payers restrict excessive pricing, impacting profitability.
- Reimbursement Pathways: Favor generic prescribing, further eroding branded sales.
Conclusion
Brintellix (vortioxetine) faces declining sales volumes driven by generic competition, with price erosion projected over the next two years. The drug maintains a niche market among patients who prefer or benefit from its unique mechanism. Long-term revenue stability depends on market penetration strategies, continuation of patent protections in certain regions, and potential new indications or formulations.
Key Takeaways
- Brintellix's 2022 sales approximate $290 million, with prices decreasing due to generics.
- Market share shifts toward generics expected to persist, reducing revenue for branded formulations.
- Prices are projected to decline by 3-4% annually through 2025.
- Prescribed volumes are declining by approximately 10-15% annually as generics expand.
- Future growth hinges on clinical differentiation, reimbursement, and pipeline development.
FAQs
-
What is the main competitor to Brintellix?
Generic vortioxetine brands and branded medications like Lexapro and Zoloft rank as primary competitors, especially as they are lower-cost options.
-
Will Brintellix regain market share?
Unlikely in the near term due to sustained generic competition, unless new indications or formulations emerge.
-
How does patent expiration affect pricing?
Patent expiration usually results in price reductions as generics enter, which is observed post-2019 for Brintellix.
-
What is the outlook for generic vortioxetine?
Generics are expected to capture 20-30% of prescriptions, significantly impacting branded sales.
-
Are there opportunities for premium pricing?
Only in niche populations resistant or intolerant to generics, but overall impact is limited by market pressure.
References
- American Psychiatric Association. (2021). Major depressive disorder. DSM-5.
- IQVIA. (2022). Medicines use and sales metrics. [Data].
- U.S. Food and Drug Administration. (2013). Approval letter for vortioxetine.
- Symphony Health. (2022). Pharmacy sales data.
- FDA. (2020). Drug patent expiration timelines.