Last updated: March 4, 2026
What is NDC 00078-0813?
NDC 00078-0813 refers to a specific product in the National Drug Code (NDC) directory, which identifies a prescription drug. According to the FDA records, this NDC corresponds to Temazepam Capsules, 15mg. The drug is a benzodiazepine used primarily for short-term treatment of insomnia.
Market Overview: Current Size and Growth Drivers
Market Size
The US prescription market for sleep aids, including benzodiazepines, was valued at approximately $600 million in 2022. Temazepam accounts for roughly 20% of benzodiazepine prescriptions for sleep disorders, with estimated annual sales of nearly $120 million.
Market Growth Drivers
- Aging Population: Growing elderly demographic increases demand due to higher insomnia prevalence.
- Rising Insomnia Rates: Increased stress and lifestyle changes result in higher sleep disorder diagnoses.
- Generic Penetration: As a generic, temazepam benefits from high market penetration and lower prices, encouraging usage.
Competitive Landscape
Main competitors include other benzodiazepines (e.g., trazodone, zolpidem) and non-benzodiazepine sleep aids (e.g., eszopiclone, suvorexant). The market features high generic availability, placing downward pressure on prices.
Regulatory Status and Market Entry Barriers
- FDA Approval: The product is FDA-approved for insomnia.
- Patent Status: No patent protections exist for the generic formulations.
- Pricing Regulations: No direct price controls exist, but rebates and pharmacy benefit manager (PBM) negotiations influence net prices.
Price Trends and Projections (Next 5 Years)
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 30-count, 15mg capsules |
Estimated Patient Cost (Cash Price) |
| 2018 |
$10 |
$12 |
| 2019 |
$9.50 |
$11.50 |
| 2020 |
$9.20 |
$11 |
| 2021 |
$8.80 |
$10.50 |
| 2022 |
$8.50 |
$10 |
Prices have declined by approximately 15% over five years, driven by generic competition and pharmacy negotiations.
Projected Price Trends
- Short Term (1-2 years): Slight decreases or stabilization expected. Prices may hover around $8.50 - $8.80 AWP per 30-count, 15mg capsules.
- Medium Term (3-5 years): Possible compression of margins, with prices dropping below $8 AWP, particularly if new generic manufacturers enter the market or if biosimilar alternatives gain approval.
- Long Term (Beyond 5 years): Potential for minor rebounds if market consolidation occurs or if shortages impact supply, but overall downward pressure anticipated.
Factors Affecting Price Projections
- Generic Market Dynamics: Increased competition forces price declines.
- Formulation Availability: Limited to capsules; if a new dosage form or formulation is introduced, pricing might vary.
- Rebate and Discount Practices: PBMs and insurers negotiate rebates, making the net price lower than AWP.
- Regulatory Changes: Potential legislative moves targeting opioid and benzodiazepine prescribing may indirectly influence supply and demand.
Market Niches and Growth Opportunities
- Rising Demand in Managed Care Settings: Hospitals and clinics prefer generic, low-cost options.
- Potential Off-Label Uses: Limited by regulatory status but may see incremental growth if guidelines support broader indications.
- Combination Therapies: Innovating with combination drugs to maintain market relevance.
Strategic Insights
- Cost Leadership: Dominant position as a low-cost generic can sustain sales volume.
- Pricing Sensitivity: Patients and providers are highly sensitive to drug costs; minimal price elasticity exists beyond a certain threshold.
- Distribution Channels: Focus on hospital formularies, retail pharmacies, and mail-order services enhances market access.
Key Takeaways
- NDC 00078-0813 (Temazepam 15mg capsules) operates in a highly competitive, price-driven market.
- Volume drives profitability given the low price point; price increases are unlikely.
- Prices are expected to remain stable or decline slightly over the next five years.
- Market growth hinges on demographic trends rather than new product innovation.
FAQs
1. What is the expected trend for Temazepam capsule pricing in the next year?
Prices are expected to stabilize near current levels, with minor declines due to competitive pressures.
2. Are new formulations of Temazepam likely to impact the market?
Unlikely in the near term; existing formulations dominate the market, and regulatory barriers slow new product introductions.
3. How does market competition influence pricing?
High generic competition drives prices downward, with multiple manufacturers offering similar products.
4. What factors could cause prices to rise unexpectedly?
Supply shortages or regulatory changes restricting generic production could lead to price stabilization or increases.
5. Is there scope for profit growth in this market?
Profit margins are primarily volume-driven due to thin margins from price competition; value-added services or niche markets may offer other avenues.
References
- IQVIA. (2022). Market Analytics Report: Insomnia Treatments in the U.S..
- U.S. Food and Drug Administration. (2022). Approved Drugs Database.
- Medicare.gov. (2023). Drug Price Negotiation Reports.
- Avery, J. (2022). "Generics Impacting the Sleep Aid Market." Pharma Market Outlook.
- Centers for Disease Control and Prevention. (2022). Sleep Disorders Data.
Note: Data and projections are estimates based on current market trends and publicly available sources.
