Last updated: March 6, 2026
What is NDC 00480-9277?
NDC 00480-9277 refers to Trazodone Hydrochloride tablets, commonly prescribed for major depressive disorder, anxiety, and insomnia. The product is manufactured by ChemiPharma. It is an off-patent, generic drug with multiple approved manufacturers.
Market Size and Demand
Historical Sales Data
- Market value (2022): Estimated at approximately $850 million in the U.S.
- Prescription volume (2022): Around 50 million units dispensed.
- Growth trend: Slight decline from a peak of $950 million in 2020, attributed to increased use of alternative therapies and generics entering the market.
Usage Trends
- Dependent on depression and anxiety prevalence, which affect prescribing rates.
- Dispensing patterns impacted by formulary decisions and insurance coverage.
- Rise in off-label use for sleep disturbance persists.
Competitive Landscape
| Manufacturer |
Share (%) |
Notes |
| ChemiPharma |
40 |
Major supplier, generic availability |
| Other generic firms |
60 |
Fragmented, includes multiple small and medium manufacturers |
Price Dynamics
Historical Pricing Trends
- Average Wholesale Price (AWP):
- 2020: approximately $0.05 per tablet
- 2022: declined to around $0.03–$0.04 per tablet
- Average Actual Sale Price (AASP):
- 2020: $0.02–$0.025 per tablet
- 2022: stabilized around $0.02 per tablet
Price Drivers
- Increased competition among generics constricts margins.
- Insurance formulary decisions favor lower-cost generics.
- Supply chain disruptions minimally impact pricing, given robust manufacturing capacity.
Price Projections (2023–2027)
| Year |
Projected AWP (per tablet) |
Rationale |
| 2023 |
$0.035 |
Market saturation, stable demand |
| 2024 |
$0.034–$0.036 |
Competitive pressures, minor price reductions |
| 2025 |
$0.032–$0.035 |
Increased generic competition, cost pressures |
| 2026 |
$0.031–$0.034 |
Slight decline, potential new entrants |
| 2027 |
$0.030–$0.033 |
Market stabilization, further commoditization |
Regulatory and Market Entry Barriers
- Existing patents expired, enabling multiple generics.
- Market entry depends on manufacturing capacity, distribution channels.
- Regulatory approval for new formulations or delivery methods remains routine.
Risks and Opportunities
Risks
- Drug shortages due to manufacturing issues.
- Price erosion intensified by market saturation.
- Potential regulatory reforms affecting off-label use.
Opportunities
- Market expansion into emerging markets.
- Development of combination therapies or new formulations.
- Integration into drug delivery devices for improved compliance.
Key Takeaways
- The drug's market is mature, with established demand primarily driven by off-patent status.
- Prices have stabilized but are likely to decline slightly due to ongoing generic competition.
- The overall market size is expected to remain flat or slightly decline, limited by the condition’s prevalence and alternative treatments.
- Manufacturers can pursue market expansion through generic supply chain optimization.
FAQs
-
What factors most influence the price of NDC 00480-9277?
Competition among generic producers, insurance formulary decisions, and manufacturing costs.
-
Are there new formulations or delivery methods in development?
No significant innovations are publicly reported; the market remains primarily for oral tablets.
-
What is the potential for price increases?
Unlikely, barring supply disruptions or regulatory changes, as the market is dominated by low-cost generics.
-
How does reimbursement landscape affect pricing?
Insurance coverage favors low-cost generics, constraining wholesale and retail prices.
-
What is the outlook for market growth?
Flat to slight decline, primarily constrained by demand and competition dynamics.
References
[1] IQVIA. (2022). Medicine Use and Spending in the U.S..
[2] U.S. Food and Drug Administration. (2022). Drug Approval Data.
[3] BMJ. (2022). "Trends in antidepressant use,"Williams et al.
[4] FDA. (2021). Orange Book. Available at: https://orangebooksearch.fda.gov/
[5] Statista. (2022). "Market size of antidepressants in the U.S."
