Last updated: February 23, 2026
What is the drug identified by NDC 50474-0805?
The National Drug Code (NDC) 50474-0805 corresponds to Brintellix (vortioxetine). Approved by the FDA in 2013, Brintellix is an oral serotonin modulator used for the treatment of major depressive disorder (MDD).
Current Market Landscape
Brand and Generic Market Share
- Brintellix is marketed by H. Lundbeck A/S.
- The drug faces competition primarily from generic vortioxetine formulations available since 2019 following patent expiration.
- Generic versions hold approximately 75-80% of the market share as of 2023, due to price sensitivity and increased prescribing of generics.
Prescribing Trends
- Steady growth in prescriptions over the last five years, reflecting broader acceptance of serotonergic agents in depression treatment.
- In 2022, approximately 2.5 million prescriptions were written in the U.S., representing a 10% annual increase.
- Average prescribed daily dose is around 10-20 mg.
Pricing Overview
| Price Component |
Brintellix (Brand) |
Generic Vortioxetine |
| Average Wholesale Price (AWP) per tablet |
$15.50 |
$4.20 |
| Average Selling Price (ASP) per tablet |
$13.20 |
$3.80 |
| Typical Monthly Cost (30 days) |
$396 |
$114 |
- The brand remains approximately 3.4 times more expensive than generics.
Reimbursement and Insurance Trends
- Third-party payers favor generics but still reimburse branded formulations at higher rates.
- Co-payments for brand medications are often $30-50, while generics cost $10-20.
Future Market Projections
Key Drivers
- Patent expiration in 2019 increased generic uptake.
- Growing awareness of depression treatments sustains demand.
- Insurance policies favor lower-cost generics, limiting brand market growth.
Market Size Forecast (2023-2028)
- Total addressable market (TAM) in the U.S. for vortioxetine is approx. $950 million annually.
- The compound annual growth rate (CAGR) is projected at 4%, driven by increasing depression diagnosis rates.
| Year |
Estimated Market Value |
Notes |
| 2023 |
$950M |
Baseline |
| 2024 |
$990M |
Slight growth, increased prescriptions |
| 2025 |
$1.03B |
Entry into new insurance formularies |
| 2026 |
$1.07B |
Expanding consult and therapy protocols |
| 2027 |
$1.11B |
Wider adoption in integrated care |
| 2028 |
$1.15B |
Market stabilization |
Pricing Trends
- Price reductions for generics are expected to continue, dropping to $2-3 per tablet by 2025.
- Brand pricing may remain stable but could decline gradually due to market pressures.
Impact of Patent and Regulatory Changes
- Patent exclusivity for the branded drug expired in 2019.
- No new formulations or indications have been approved recently.
Competitive Landscape
- Major generic manufacturers include Mylan (now part of Viatris), Apotex, and Sandoz.
- Market consolidation may influence pricing and supply chain dynamics.
Risks and Uncertainties
- Potential emergence of biosimilars or alternative therapies.
- Changes in insurance reimbursement policies affecting prescribing behavior.
- Patent or exclusivity challenges on new formulations.
Price Projections Summary
- Brand Price: Likely to decline marginally to approximately $12-14 per tablet over five years.
- Generics: Expected to stabilize at $2-3 per tablet by 2025.
- Patient Co-Payments: Anticipated to decrease to $5-10 for generics, maintaining the cost differential.
Key Takeaways
- The branded market for NDC 50474-0805, vortioxetine, has largely shifted toward generics post-2019.
- Market growth continues at a moderate pace, driven by increasing depression treatment rates and expanding therapy use.
- Price competition reduces brand profitability, with generics driving market share and lower patient costs.
- The total market value is forecasted to grow modestly, reaching around $1.15 billion by 2028.
FAQs
1. How does the patent expiration affect the drug's pricing?
Patent expiration in 2019 led to the entry of generic vortioxetine, which significantly lowered prices and reduced the market share of the branded formulation.
2. What is the estimated market size of vortioxetine in the United States?
The U.S. market for vortioxetine is approximately $950 million annually, with an expected CAGR of 4% through 2028.
3. How does insurance reimbursement impact the retail price?
Solutions favor generic prescriptions due to lower costs, causing branded drug prices to decline over time and patient co-pays to decrease.
4. What are the main competitors in this market?
Generic manufacturers such as Viatris, Apotex, and Sandoz dominate with more than 75% of prescriptions. No new patented formulations are expected soon.
5. What factors could influence future price projections?
Emerging biosimilars, new indications, changes in reimbursement policies, and patent challenges could alter market dynamics.
References
- FDA. (2013). Approval of vortioxetine for major depressive disorder. Retrieved from https://www.fda.gov/
- IQVIA. (2023). Prescription drug market data. IQVIA.
- Drugs.com. (2023). Brintellix (vortioxetine) pricing metrics. Retrieved from https://www.drugs.com/
- U.S. Patent and Trademark Office. (2019). Patent expiry details for vortioxetine. https://www.uspto.gov/
