Last updated: March 8, 2026
What is NDC 50474-0001?
NDC 50474-0001 identifies Zolpidem Tartrate Extended-Release (CR) tablets, a prescription medication used for insomnia. The drug's primary indication covers short-term treatment of sleep disturbances. It was approved by the FDA in 2013 and is marketed under various brand names, with Ambien CR being the most recognized (FDA, 2013).
Market Overview
Market Size and Demand
The insomnia treatment market is estimated to reach $2.8 billion globally by 2025, with the U.S. accounting for approximately 65% of sales (MarketWatch, 2022). Zolpidem-based products, including extended-release formulations, comprise about 25% of this market segment.
Competitive Landscape
Main competitors include:
- Zolpidem immediate-release (e.g., Ambien)
- Eszopiclone (Lunesta)
- Ramelteon (Rozerem)
- Suvorexant (Belsomra)
Extended-release products face competitive pressure from immediate-release formulations and newer agents with different mechanisms.
Market Dynamics
Drivers:
- Increasing prevalence of insomnia (estimated at 30% worldwide)
- Aging population with higher sleep disorder rates
- Off-label use for anxiety-related sleep issues
Challenges:
- Regulatory scrutiny concerning dependency risks
- Growing focus on non-pharmacological interventions
- Patent expirations of key formulations
Price Analysis
Historical and Current Pricing
Based on publicly available pricing data, the average wholesale price (AWP) for NDC 50474-0001 (Zolpidem CR 12.5 mg) is approximately $20 for a 30-tablet bottle (as of Q4 2022). Medicaid reimbursement rates for the same product hover around $15, reflecting typical discounting.
Comparative Pricing
| Product |
Strength |
Average Wholesale Price (AWP) |
Market Share (2022) |
| NDC 50474-0001 (Zolpidem CR) |
12.5 mg |
$20 |
20% |
| Ambien IR |
10 mg |
$18 |
25% |
| Lunesta |
3 mg |
$25 |
15% |
| Belsomra |
10 mg |
$22 |
10% |
Pricing Trends and Projections
Forecasting indicates a slight decline in unit prices driven by increased use of generic formulations and biosimilars. Yearly price erosion of 2-3% is expected between 2023 and 2025, assuming continued market saturation and competitive discounts.
Market Projections (2023-2027)
| Year |
Estimated Market Size (USD Billion) |
Projected Growth Rate |
Key Factors |
| 2023 |
0.12 |
3% |
Steady demand, minor price erosion |
| 2024 |
0.125 |
4.2% |
Increased competitive pricing, expansion into emerging markets |
| 2025 |
0.13 |
4.8% |
Stabilized demand, generic penetration peaks |
| 2026 |
0.135 |
3.8% |
Market saturation, focus on formulary placement |
| 2027 |
0.14 |
3.6% |
Growth driven by aging demographics |
Regulatory and Patent Considerations
The original patent for Ambien CR expired in 2018 in the U.S., leading to increased generic availability. Nonetheless, secondary patents or exclusivity periods may delay generic penetration depending on the manufacturer.
Key Pricing Factors
- Generic availability reduces the retail price by approximately 40-50%
- Insurance coverage favors formulary inclusion and impacts patient out-of-pocket costs
- Supply chain disruptions can cause price volatility, especially during market entry of new generics
Summary
NDC 50474-0001, Zolpidem Tartrate Extended-Release (CR), maintains a stable market presence with moderate growth projected. Prices are expected to decline gradually due to generic competition. The drug's market share is likely to plateau as newer sleep agents and non-pharmacological treatments gain prominence.
Key Takeaways
- The U.S. sleep aid market is growing, driven by demographic shifts and rising sleep disorder prevalence.
- NDC 50474-0001 faces pricing pressures from generic entry; prices have declined approximately 2-3% annually since 2018.
- Market size is forecasted to increase modestly, reaching around $140 million by 2027.
- Competition from newer agents and alternative therapies influences market dynamics.
- Insurance coverage and formulary positioning significantly affect retail prices and access.
FAQs
Q1: When will generic versions of NDC 50474-0001 be widely available?
A: Generic Zolpidem CR became available post-2018 following patent expirations, increasing competition and reducing prices.
Q2: How does insurance coverage impact patient costs?
A: Insurance plans often favor generic drugs, lowering patient out-of-pocket expenses when generics are accessible.
Q3: Are there upcoming patent protections that could delay generics?
A: Secondary patents or exclusivity provisions may extend brand protection until at least 2023, but these are generally short-term.
Q4: How does the demand for sleep aids correlate with demographic trends?
A: Aging populations increase demand, as sleep issues are more common among older adults.
Q5: What are the main factors influencing future price trends?
A: Introduction of generics, shifts in prescribing patterns, insurance formulary decisions, and the emergence of alternative therapies.
References
- FDA. (2013). Zolpidem tartrate extended-release (cr) tablets approval announcement. Retrieved from https://www.fda.gov
- MarketWatch. (2022). Sleep aid market report. Retrieved from https://www.marketwatch.com
