Last updated: February 13, 2026
Overview
NDC 00169-4314 corresponds to Trazodone Hydrochloride Tablets, 50 mg. It is primarily used to treat depression and off-label for insomnia. The drug is marketed by Prasco Laboratories in the generic segment.
Current Market Landscape
Market Size & Usage
- Global depression treatment market was valued at approximately $15 billion in 2022 and is expected to reach around $22 billion by 2030, growing at a CAGR of 4.7% (source: Grand View Research[1]). Trazodone accounts for an estimated 8% of prescriptions due to its off-label use for insomnia.
- US prescriptions for trazodone have increased 12% annually from 2018 to 2022, mainly driven by off-label use[2].
Competitive Position
- Several generic manufacturers, including Sun Pharmaceutical and Teva, dominate the market.
- The branded alternative, Oleptro (also trazodone), was withdrawn in 2019 following patent expiration and market erosion.
Market Share & Dynamics
- The generic segment holds approximately 85% of trazodone prescriptions.
- Price competition among generics influences market share fluctuations.
Price Trends and Forecasts
Current Prices
- The average retail price for a 30-day supply (30 x 50 mg tablets) retail is approximately $10–15.
- Wholesale acquisition cost (WAC) averages $0.20 per tablet, roughly $6 per 30-tablet pack.
Historical Price Movements
- Since patent expiry in 2014, prices declined sharply from over $20 per 30-day supply to current levels, reflecting increased generic competition.
- Slight upward adjustments observed in 2021 and 2022 due to supply chain disruptions.
Forecast to 2028
- Price compression is expected to continue, with a compound annual decline of roughly 2–3% in wholesale prices.
- Given current trends, a standard wholesale price for 50 mg tablets is projected to stabilize at around $0.15–0.20 per tablet.
- Retail prices may remain steady due to pharmacy markups but are unlikely to exceed $15–20 per month.
Regulatory and Market Impacts
- Patent status: The original patent expired in 2014, leading to a broad generic market.
- Potential regulatory changes: FDA’s efforts to promote drug pricing transparency could marginally influence prices. No major reform impacting trazodone specifically is anticipated in the next five years.
- Supply chain issues, such as raw material shortages, could potentially elevate prices slightly but have not significantly impacted the broader market since early 2022.
Entry & Investment Considerations
- Entry costs are low, with patent barriers minimal since the drug is generic.
- Margins are thin but stable for established manufacturers.
- Additional market growth depends on the off-label utilization rates, which are driven by clinical practice patterns and prescribing guidelines.
Key Takeaways
- NDC 00169-4314 is a generic trazodone 50 mg tablet, dominant in the depression and off-label insomnia markets.
- The market is highly competitive, with rapid price declines since patent expiry.
- Wholesale prices are forecasted to stay stable around $0.15–0.20 per tablet through 2028, with retail prices remaining near $15 per month.
- Market growth relies on off-label use trends; influence from regulatory policy is limited.
- Entry costs are low; profit margins are compressed but predictable.
FAQs
1. What factors influence trazodone pricing?
Generic competition, manufacturing costs, supply chain stability, and prescribing rates impact trazodone pricing. Price declines primarily result from increasing generic market share.
2. How does trazodone's off-label use affect its market?
Off-label prescribing for insomnia sustains prescriber demand, affecting volume but not significantly altering retail prices due to intense generic competition.
3. Are there upcoming patents or exclusivities for trazodone?
No. The original patents expired in 2014, leaving the market fully open to generics.
4. What regulatory trends could impact pricing?
Drug transparency initiatives and potential formulary preferences could marginally influence pricing but are unlikely to cause drastic shifts in the near term.
5. How does supply chain disruption influence the market?
Supply chain issues could marginally elevate wholesale prices temporarily but have not caused significant long-term price changes since 2022.
Citations
[1] Grand View Research. "Depression Treatment Market Size & Trends." 2022.
[2] IQVIA. "Prescribing Trends for Trazodone," 2022.
