Last updated: April 2, 2026
What is NDC 00187-5812?
NDC 00187-5812 corresponds to Temazepam Capsules. It is a prescription medication used primarily to treat insomnia, acting as a sedative and hypnotic agent. The product is marketed by Teva Pharmaceuticals, a major generic drug manufacturer.
Market Size and Key Trends
Current Market Landscape
- Global Insomnia Market: Valued at approximately USD 4.8 billion in 2022, projected to grow at a CAGR of 3.5% through 2030 [1].
- U.S. Market Share (2022): Temazepam holds a significant segment of prescription hypnotic drugs, with estimated annual sales of USD 250 million within the U.S. [2].
Competitive Environment
- Major Competitors: Eszopiclone (Lunesta), Zolpidem (Ambien), and newer agents like suvorexant.
- Generics Impact: A marked increase in generic versions from multiple manufacturers reduces price points and market share concentration.
- Regulatory Factors: Tightening of opioid and sedative prescribing guidelines influences demand dynamics for benzodiazepines.
Prescribing Trends
- Slight decline in benzodiazepine prescriptions due to safety concerns, but Temazepam remains favored for sleep management in certain populations.
- Increasing interest in non-benzodiazepine sleep aids suggests a possible downtrend over the next five years.
Price Analysis and Projections
Current Price Range
- Average Wholesale Price (AWP): Around USD 0.50 per capsule for 30 mg strength (e.g., Teva brand).
- Actual Transaction Price (ATP): Approximately USD 0.30 per capsule, influenced by negotiations and discounts.
- Patient Cost (Insurance Copay): Ranges from USD 5 to USD 15 per prescription, depending on formulary and coverage.
Historical Price Trends
| Year |
Average Price per Capsule |
Notes |
| 2018 |
USD 0.65 |
Higher due to limited generics |
| 2020 |
USD 0.55 |
Increased generics entry |
| 2022 |
USD 0.50 |
Market stabilization; price sensitivity |
Price Projection (2023-2027)
- Short-term (next 2 years): Slight decline to USD 0.45–0.48 per capsule as competition intensifies.
- Medium-term (3–5 years): Stabilization around USD 0.40–0.45, driven by increased generic penetration and price negotiations.
- Long-term (5+ years): Possible further decline to USD 0.35–0.40 if newer non-benzodiazepine drugs supplant traditional hypnotics.
Factors Influencing Price Trends
- Generic Competition: Entry of multiple generic manufacturers directly reduces prices.
- Regulatory Changes: Restrictions on benzodiazepine prescribing may decrease volume, impacting pricing.
- Market Demand: Aging population maintains demand, but safety concerns may limit growth.
- Reimbursement Policies: Medicaid, Medicare, and private insurers' formulary decisions influence patient access and, consequently, effective market prices.
Revenue Projections
Assuming 5 million capsules sold annually in the U.S., with a price decline to USD 0.40 and a 10% global market share, revenues could approximate USD 2 million annually. Market growth or decline hinges on prescribing trends and regulatory changes.
Key Risks and Opportunities
Risks
- Increased regulatory scrutiny on benzodiazepines.
- Shift towards newer sleep therapies.
- Potential safety concerns impacting prescribing behavior.
Opportunities
- Expansion into emerging markets with less stringent regulations.
- Development of combination therapies to enhance efficacy and safety.
- Market penetration of generic versions with aggressive pricing strategies.
Conclusion
The market for Temazepam capsules under NDC 00187-5812 is characterized by moderate growth prospects, driven by aging demographics and existing demand for sleep aids. Prices are trending downward, with forecasts indicating a gradual decline over the next five years due to competitive pressures and regulatory factors. The product remains relevant in specific patient segments, but future growth may depend on regulatory and market shifts towards alternative sleep therapies.
Key Takeaways
- The global insomnia market is expanding, but benzodiazepines like Temazepam face declining demand amid safety concerns.
- The U.S. market sees average prices around USD 0.30–0.50 per capsule, with potential further declines.
- Competition from generics is expected to suppress prices further, impacting revenue.
- Regulatory pressure and evolving prescribing practices constitute key risks to market stability.
- Opportunities exist in expanding to emerging markets and developing combination therapies.
FAQs
1. What is the primary use of Temazepam?
It treats insomnia by inducing sleep, typically for short-term use due to safety concerns.
2. How does generic competition affect Temazepam's price?
Generic entries lower prices significantly, reducing revenue potential for brand-name versions.
3. What regulatory challenges could impact the market?
Restrictions on benzodiazepine prescribing and increased safety warnings may limit demand.
4. Are there alternatives to Temazepam for sleep disorders?
Yes, non-benzodiazepine sedatives, melatonin receptor agonists, and behavioral therapies.
5. How might global markets influence future sales?
Emerging markets with less restrictive regulations could offer growth opportunities.
References
[1] Grand View Research. (2023). Insomnia Treatment Market Size, Share & Trends Analysis. https://www.grandviewresearch.com/industry-analysis/insomnia-treatment-market
[2] IQVIA. (2022). U.S. Prescription Drug Market Data. https://www.iqvia.com/insights/the-iqvia-institute
