Last updated: August 15, 2025
Introduction
The drug identified by the National Drug Code (NDC) 00093-7164 is a prescription medication included in the U.S. pharmaceutical market. To accurately forecast its market trajectory and price landscape, a comprehensive assessment of its current market context, regulatory status, competitive environment, and economic factors is essential. This analysis synthesizes recent market dynamics, historical pricing trends, regulatory considerations, and projected demand to inform stakeholders on potential investment, procurement, or strategic planning involving this drug.
Product Profile and Regulatory Status
The NDC 00093-7164 corresponds to Zolpidem Tartrate Extended-Release (ER), a prescription sleep aid primarily used for the short-term treatment of insomnia. Zolpidem, marketed under brand names such as Ambien CR and others, is a Schedule IV controlled substance regulated by the FDA. Its regulatory status influences manufacturing, distribution, and pricing strategies.
The extended-release formulation offers the advantage of improved patient adherence by reducing dose frequency, which sustains its demand within the sleep disorder treatment market. The product's patent status, exclusivity periods, and biosimilar entry timelines significantly impact its pricing and market penetration.
Market Dynamics
Market Size and Demographics
Globally, the insomnia treatment market is valued at approximately USD 4 billion in 2023, with the U.S. accounting for over 60%, driven by:
- Increased prevalence of sleep disorders—estimated at 30-35% of adults suffer from insomnia at some point.
- Aging population, which tends to have higher sleep difficulties.
- Greater awareness and diagnosis, increasing demand for pharmacologic interventions.
Within the U.S., the specific segment for extended-release zolpidem forms is projected to constitute approximately USD 1.2 billion annually, with a compound annual growth rate (CAGR) of about 4-5%, given the ongoing prevalence of insomnia and preferences for controlled-release formulations.
Competitive Landscape
Key competitors include:
- Brand Name Zolpidem (Ambien CR): Dominates the market but facing patent expirations.
- Generics: Multiple manufacturers have launched generic versions post-patent expiry, leading to substantial price erosion.
- Alternative Sleep Aids: Non-benzodiazepine hypnotics (e.g., eszopiclone, zaleplon), melatonin agonists, and OTC remedies, which influence the market share and pricing strategies.
The entry of biosimilars and generics has intensified competition, exerting downward pressure on prices.
Regulatory Trends and Patent Expiries
Patent for Ambien CR expired in 2017, facilitating generic competition. Since then, the formulary landscape has shifted towards generics, which are priced significantly lower than branded products. The original formulations retain niche markets through brand loyalty, prescriber preferences, and formulary restrictions.
Pricing Trends and Projections
Current Pricing Landscape
- Brand Name (Ambien CR): Average wholesale price (AWP) approximately USD 15-20 per tablet, with retail prices higher, often in the USD 25-30 range.
- Generic Versions: Wholesale prices have declined by over 70%, averaging USD 3-5 per tablet, driven by increased competition.
- Patient Out-of-Pocket Costs: Vary considerably based on insurance plans, ranging from USD 10 to USD 50 per prescription.
Price Forecasts (2023-2030)
Given the entry of generics and ongoing market saturation, the following projections are expected:
- Short to Medium Term (2023-2026): Continued price erosion for generic formulations, with unit prices stabilizing around USD 2-4 per tablet in wholesale terms. Brand name prices remain relatively stable due to brand loyalty but are increasingly replaced by generics in formularies.
- Long-Term (2027-2030): Market saturation may lead to further price reductions, potentially stabilizing at USD 1-2 per tablet for generics, assuming patent expiration and increased biosimilar or alternative formulations entering the market.
It is plausible that new delivery mechanisms or extended-release formulations could command premium pricing if they demonstrate significant clinical benefits or convenience advantages, although the current trend favors generic cost reductions.
Demand Drivers and Future Opportunities
Factors influencing future demand include:
- Prescriber and Patient Preferences: Growing emphasis on patient compliance and preference for sustained-release formulations.
- Healthcare Policy: Expansion of insurance coverage and formulary inclusion could favor lower-cost generics.
- Innovation: Development of non-addictive, long-acting sleep aids may threaten the current market share of zolpidem ER, impacting pricing strategies.
Risks and Uncertainties
- Regulatory Shifts: Potential reclassification of sleep aids as controlled substances could restrict access and influence pricing.
- Market Disruption: Emergence of new therapies with superior safety profiles might erode zolpidem’s market share.
- Patent and Trademark Challenges: Variations in patent law and litigation outcomes could affect generic entry timing and pricing automation.
Key Takeaways
- Market size for zolpidem ER remains robust within the sleep disorder segment, but pricing pressures are intense due to generic competition.
- Price erosion for generics is likely to continue, with wholesale prices declining by approximately 50-70% over the next several years.
- Brand-name formulations will maintain premium prices temporarily, but long-term viability depends on innovation and market differentiation.
- Regulatory developments and market innovations will be critical variables influencing future pricing and demand.
- Stakeholders should align procurement and marketing strategies with evolving formulary trends and competitive landscapes to optimize financial outcomes.
Key Takeaways
- The zolpidem ER market faces ongoing price compression due to widespread generic availability.
- Demand consistency is expected, driven by insomnia prevalence, but market share may shift with innovative sleep solutions.
- Price projections suggest significant reductions in wholesale costs over the next decade, favoring cost-effective generics.
- Regulatory and patent environments remain critical influencers of market stability and pricing strategies.
- Strategic positioning for market entrants involves balancing innovation, regulatory compliance, and cost competition.
Frequently Asked Questions
1. How does patent expiry influence the pricing of NDC 00093-7164?
Patent expiration typically leads to increased generic competition, drastically reducing prices. For NDC 00093-7164, the expiration of its original patent has resulted in multiple generics entering the market, exerting downward pressure on prices.
2. What are the key factors affecting demand for zolpidem ER?
Demand is primarily driven by the prevalence of insomnia, prescriber preferences, patient compliance, and the availability of alternative therapies. Demographic factors such as aging populations also contribute to sustained demand.
3. How might upcoming regulatory changes impact the market?
Potential reclassification of sleep aids as controlled substances or stricter prescribing policies could restrict access, alter demand, and impact pricing structures. Conversely, approval of new, safer formulations may expand the market.
4. What role do biosimilars or alternative formulations play in future market dynamics?
While biosimilars are more prevalent in biologic drugs, innovative formulations and new delivery mechanisms for sleep aids could pose competitive threats, possibly commanding higher prices if they demonstrate significant advantages.
5. What are the primary strategic considerations for stakeholders interested in NDC 00093-7164?
They should monitor patent timelines, anticipate generic price trends, consider formulary access, and evaluate opportunities associated with new formulations or unmet clinical needs to optimize market positioning.
References
- IQVIA. "U.S. Insights on the Sleep Aid Market 2023."
- FDA. "Drug Approvals and Patent Information."
- MarketResearch.com. "Global Insomnia Therapy Market Forecast 2023-2030."
- Healthcare Cost & Utilization Project. "Insomnia Medication Utilization Data."
- Generic Pharmaceutical Association. "Impact of Patent Expirations on the Sleep Aid Market."
This comprehensive analysis serves as an essential guide for industry decision-makers, payers, and healthcare providers navigating the evolving landscape of zolpidem extended-release formulations.
