Last updated: July 27, 2025
Introduction
The pharmaceutical industry continuously evolves, driven by innovations, regulatory landscapes, and market dynamics. Analyzing the market and projective pricing for specific drugs enables stakeholders—including manufacturers, investors, healthcare providers, and policymakers—to make informed decisions. This report assesses the current market landscape and provides detailed price projections for the drug identified by NDC: 00078-0609.
Drug Profile Overview
NDC: 00078-0609 corresponds to Trazodone Hydrochloride Tablets, 50 mg. Trazodone is primarily prescribed for depression, often utilized off-label for sleep disorders. Its established safety profile and widespread off-label use contribute to consistent demand.
Formulation and Indications
- Formulation: Oral tablets, 50 mg
- Primary indication: Major depressive disorder (MDD)
- Off-label uses: Insomnia, anxiety disorders
Manufacturers and Market Presence
Major pharmaceutical companies such as Otsuka Pharmaceutical and Teva Pharmaceuticals manufacture trazodone, with several generic versions available, intensifying market competition.
Market Dynamics
Market Size and Demand Trends
The global antidepressant market, estimated at approximately $15 billion in 2022, includes trazodone as a significant component, especially in the generic segment. In the United States, trazodone’s off-label use for sleep has sustained demand growth, projecting an overall compound annual growth rate (CAGR) of about 3-4% through 2027[1].
Competitive Landscape
With numerous generic manufacturers, trazodone faces stiff price competition. The entry of biosimilars is limited, given its chemical entity status. However, price erosion for generics influences market valuation and profit margins.
Regulatory Environment
FDA approval and compliance standards influence market stability. The increasing adoption of biosimilar regulations and accelerated approval pathways may impact future availability and innovation.
Supply Chain Factors
Raw material procurement and manufacturing capacity influence supply stability. Supply chain disruptions, such as those seen during COVID-19, have historically caused price volatility but are gradually stabilizing.
Pricing Analysis
Current Price Landscape
The average wholesale acquisition cost (WAC) for trazodone 50 mg tablets is approximately $0.20 per tablet. Retail pharmacy prices fluctuate based on insurance coverage, rebates, and discounts, with cash-pay prices averaging around $0.40–$0.60 per tablet.
Historical Price Trends
Over the past five years, trazodone prices have experienced a downward trend due to increased generic competition. The average price per 30-day supply (assuming 50 mg, 1 tablet daily) has decreased from around $15 in 2018 to approximately $12–$15 in 2023[2].
Impact of Market Dynamics on Pricing
The ongoing shift toward generic prescribing, insurance formulary preferences, and potential for patent litigations influences prices. Any regulatory changes promoting biosimilar entry could further reduce prices, although such developments are currently nascent for small-molecule drugs.
Price Projections
Short-term (1-2 years)
- Projected Price Range: $0.18–$0.22 per tablet
- Rationale: Market saturation with generic versions and stable demand maintain prices with minimal fluctuations. Insurance negotiations and rebate strategies are expected to exert downward pressure, balancing out demand stability.
Medium-term (3-5 years)
- Projected Price Range: $0.15–$0.20 per tablet
- Rationale: Increased generic market penetration and payer negotiations are likely to drive prices downward. Potential legislative or regulatory initiatives promoting drug affordability could further influence prices.
Long-term (5+ years)
- Projected Price Range: $0.10–$0.15 per tablet
- Rationale: Continued generic proliferation, potential biosimilar developments, and increased market competition could depress prices further. Disruptive factors like new formulations or alternative therapies may also impact pricing.
Market Risks and Opportunities
Risks
- Regulatory hurdles: Changes in FDA policies or reimbursement frameworks could alter market dynamics.
- Market competition: Excess supply and aggressive pricing by competitors could suppress profits.
- Generic erosion: Price declines driven by commoditization.
Opportunities
- Expanded indications: Developing new formulations or combination therapies could extend product lifecycle.
- Market penetration: Emerging markets may offer growth opportunities due to increasing mental health awareness.
- Cost management: Streamlining manufacturing and distribution can enhance margins amid declining prices.
Conclusion
NDC: 00078-0609, representing trazodone hydrochloride 50 mg tablets, remains a mature product characterized by high generic penetration and relatively stable demand. The consistent downward pressure on prices, driven by intense competition and market saturation, is expected to continue. Stakeholders should monitor regulatory developments, market entry of biosimilars, and evolving prescribing practices for strategic positioning.
Key Takeaways
- Trazodone 50 mg tablets have a well-established, mature market with steady demand driven by off-label use.
- Current average wholesale prices hover around $0.20 per tablet, with retail prices slightly higher.
- Prices are projected to decline gradually, reaching approximately $0.10–$0.15 within five years.
- Market risks include regulatory changes, market saturation, and aggressive generic competition.
- Opportunities lie in expanding indications, penetrating emerging markets, and optimizing manufacturing efficiencies.
FAQs
1. What factors influence the price of trazodone 50 mg tablets?
Market saturation with generics, competition, insurance reimbursement policies, regulatory environment, and input costs predominantly influence pricing.
2. How does the competition impact the market for NDC 00078-0609?
Intense competition from multiple generic manufacturers drives prices downward, limiting profit margins and stabilizing average prices.
3. Are there any regulatory changes expected that could affect this drug’s market?
Potential regulatory shifts, such as policies promoting biosimilars or price controls, could impact the market, though current policies mainly target other areas.
4. What are the primary markets for trazodone besides the US?
Europe, Canada, and parts of Asia primarily consume trazodone, with growth driven by increasing recognition of mental health concerns.
5. Can new formulations or delivery methods influence future pricing?
Yes. Extended-release formulations or combination therapies could command premium prices, offsetting declines in generic prices.
References
[1] Global antidepressant market report, Market Research Future, 2022.
[2] IQVIA Pharmaceutical Data, 2023.
