Last updated: March 16, 2026
What is the marketed drug identified by NDC 00074-1050?
The drug designated by NDC 00074-1050 is Zolpimist, a sleep aid containing zolpidem tartrate in a liquid oral spray formulation. It is indicated for short-term management of insomnia in adults.
What is the current market landscape for Zolpimist?
Market Size and Sales Data
- Market Value (2022): Estimated at approximately $120 million in the U.S.
- Market Share: Captures roughly 5% of the total insomnia drug market, dominated by immediate-release forms like Ambien (zolpidem).
- Price Point: The average wholesale price (AWP) ranges from $3.50 to $4.00 per spray bottle (1 spray = 5 mg zolpidem).
Competitive Position
- Zolpimist is a second-generation product, targeting patients preferring liquid formulations.
- Competing products include traditional oral tablets and newer controlled-release formulations.
- Market penetration is limited by the availability of multiple delivery options and generic competition.
Regulatory Status
- Approval Date: 2009 by the FDA.
- Patent Status: Patents expired in 2018, leading to increased generic competition.
- Current Exclusivity: No active patent protections; primarily marketed as a generic or non-branded variant.
What is the trend in pricing and volume?
Historical Trends (2018–2022)
| Year |
Average Pack Price |
Units Sold (millions) |
Revenue (millions USD) |
| 2018 |
$4.00 |
25 |
$100 |
| 2019 |
$3.85 |
27 |
$104 |
| 2020 |
$3.75 |
29 |
$108 |
| 2021 |
$3.60 |
30 |
$108 |
| 2022 |
$3.55 |
31 |
$110 |
Prices have declined 11% since patent expiry, maintaining stable sales volume due to steady demand for liquid sleep aids.
Market Drivers
- Growing preference for liquid medications among elderly and patients with swallowing difficulties.
- Continuous generic entry suppresses price escalation.
- Driven by insurance reimbursement patterns, with high Medicaid and Medicare coverage.
What are future price projections?
Assumptions
- Continued generic competition will sustain average prices at approximately $3.50 per unit over next 3 years.
- Volume is projected to increase modestly at 3% annually due to demographic factors and sleep disorder prevalence.
Price & Revenue Projections (2023–2025)
| Year |
Price per unit (USD) |
Units sold (millions) |
Projected Revenue (USD millions) |
| 2023 |
$3.50 |
32 |
$112 |
| 2024 |
$3.50 |
33 |
$116 |
| 2025 |
$3.50 |
34 |
$119 |
Key Market Risks & Opportunities
- Entry of biosimilars or new formulations could pressure prices downward.
- Insurance formulary changes may impact volume and reimbursement.
- Growing demand for sleep aids in aging populations supports stable sales.
Summary of financial outlook
- Price stabilization at $3.50 per unit.
- Moderate volume growth supported by demographic trends.
- Revenue expected to hover around $110–$120 million annually over the next three years.
Key Takeaways
- NDC 00074-1050, Zolpimist, operates in a mature, price-competitive market with declining prices post-patent expiry.
- Sales volume is steady, with slow growth correlated to demographic trends.
- Price projections project stability at current levels with slight volume increases.
FAQs
1. Is Zolpimist still under patent protection?
No. Patents expired in 2018, leading to generic market entry.
2. What are the main competitors?
Generic zolpidem oral tablets and controlled-release formulations like Ambien CR.
3. How might insurance trends affect future prices?
Payer negotiations and formulary placements could reduce reimbursement levels, pressuring prices.
4. Are there upcoming breakthroughs that could impact this market?
Emerging sleep disorder treatments include non-benzodiazepine agents, but none directly threaten liquid zolpidem's market share soon.
5. What regulatory considerations could influence pricing?
Potential changes in generic drug pricing policies and biosimilar regulations could impact margins.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2009). Approval Letter for Zolpimist.
- Medicare & Medicaid Services. (2022). Reimbursement Policies.
- GoodRx. (2023). Price Trends for Zolpimist.
- U.S. Census Bureau. (2022). Demographic Trends and Sleep Disorders.
