Last updated: March 13, 2026
What is NDC 70436-0161?
NDC 70436-0161 refers to a specific medication listed in the National Drug Code (NDC) database. The code corresponds to Brintellix (vortioxetine), a prescription drug approved by the FDA for the treatment of major depressive disorder (MDD).
- Manufacturer: Takeda Pharmaceuticals America, Inc.
- Formulation: 10 mg and 20 mg tablets.
- Indications: Major depressive disorder in adults.
- Approval Date: December 2013.
Market Overview
Current Market Size and Trends
The antidepressant segment, including vortioxetine, is valued at approximately $14 billion globally in 2022. The U.S. market accounts for over 60% of sales. Vortioxetine's market share among antidepressants is estimated at 3-5% and is growing driven by its unique mechanism of action and favorable side effect profile.
Competitive Landscape
Main competitors include:
- SSRIs: Sertraline, Fluoxetine, Citalopram
- SNRIs: Venlafaxine, Duloxetine
- Other Novel Agents: Vilazodone, Esketamine
Vortioxetine differentiates on efficacy and tolerability, contributing to its incremental market penetration.
Key Drivers
- Increasing prevalence of depression, with an estimated 7% of adults** affected in the U.S. (CDC, 2022).
- Growing acceptance of newer antidepressants with fewer side effects.
- Expanding indications to treatment-resistant depression, pending further studies.
Regulatory Dynamics
No recent label extensions or new indications have been approved as of 2023. The drug remains priced relatively high, reflecting its market tier and patent protections.
Price Analysis and Projections
Current Pricing
- Average Wholesale Price (AWP): ~$6.00 per 10 mg tablet; ~$12.00 per 20 mg tablet.
- Average Manufacturer's Price (AMP): Approximately 70-80% of AWP.
- Average Retail Price (ARP): Typically 2-3 times higher than AMP due to pharmacy markup.
Price Trends (2020–2023)
| Year |
Average Wholesale Price (per 20 mg tablet) |
Notes |
| 2020 |
$6.00 |
Initial post-launch prices |
| 2021 |
$6.00 |
Stable in early years |
| 2022 |
$6.00 – $6.50 |
Slight increase due to inflation, formulary adjustments |
| 2023 |
$6.50 |
Continued slight rise, market stabilization |
Price Projection (2024–2028)
Assuming a compound annual growth rate (CAGR) of 2-3% driven by inflation and potential formulary pressures:
| Year |
Predicted AWP per 20 mg tablet |
Notes |
| 2024 |
~$6.65 |
Slight increase |
| 2025 |
~$6.80 |
Market stability |
| 2026 |
~$7.00 |
Possible formulary shifts |
| 2027 |
~$7.15 |
Price adjustments |
| 2028 |
~$7.40 |
Market saturation |
External Factors Impacting Price
- Patent expiration anticipated around 2028, likely leading to generic entry.
- Generic competition could reduce prices by 50% or more within 1-2 years post-patent expiry.
- Payor negotiations and formulary inclusion may influence net prices with potential discounts or rebates.
Future Market Entry and Impact
Biosimilar and Generic Competition
- Patent expiry expected circa 2028, with generics anticipated shortly after.
- Historical trend indicates 50-70% price erosion within the first two years following generic entry.
Line Extension and New Uses
- No current proposals for new formulations or indications.
- Any future label expansions will impact demand and pricing.
Conclusion
The drug represented by NDC 70436-0161, vortioxetine, maintains a stable pricing trajectory with modest growth predicted until patent expiration. The imminent entry of generics around 2028 will significantly affect its market share and price structure.
Key Takeaways
- Current retail price near $6.00 per 20 mg tablet, with minor annual increases.
- Market share remains limited but grows gradually due to its differentiated profile.
- Patent expiration expected in 2028, leading to potential 50%+ price reductions with generics.
- Market drivers include rising depression prevalence and prescriber preference for novel antidepressants.
- External factors like formulary negotiations influence net prices more than list prices.
FAQs
1. When is patent expiration for vortioxetine?
Expected around 2028, after which generics will likely enter the market.
2. How will generic entry impact the current price?
Prices could decrease by up to 50% or more within two years of patent expiry.
3. Are there any scheduled formulation changes?
No publicly announced changes; current formulations are standard.
4. What is the expected growth of vortioxetine's market share?
Gradual increase driven by clinical positioning, but remaining a niche segment relative to SSRIs.
5. What factors influence the drug’s pricing?
Market competition, patent status, formulary negotiations, prescribing trends, and inflation.
References
- CDC. (2022). Depression prevalence and statistics. Centers for Disease Control and Prevention.
- IQVIA. (2022). U.S. prescription drug market data.
- FDA. (2013). Approval announcement for vortioxetine. [Press release]. U.S. Food and Drug Administration.
- Generic Insight. (2023). Post-patent entry price erosion trends.
- Takeda Pharmaceuticals. (2023). Vortioxetine product information and market access reports.
[1] Centers for Disease Control and Prevention (CDC). (2022). Major depressive disorder prevalence. https://www.cdc.gov
[2] IQVIA. (2022). U.S. prescription market data.
[3] U.S. Food and Drug Administration (FDA). (2013). Vortioxetine approval. https://www.fda.gov
[4] Generic Insight. (2023). Impact of generic competition.
[5] Takeda Pharmaceuticals. (2023). Vortioxetine product dossiers.
