Last updated: February 25, 2026
What is NDC 00527-1282?
NDC 00527-1282 is a prescription drug identified by the National Drug Code (NDC). It corresponds to Zolpidem Tartrate Extended-Release (ER) 12.5 mg marketed by Apotex Corp. It is used for the treatment of insomnia and belongs to the sedative-hypnotic class.
Market Size and Demand Drivers
Current Market Position
- Key competitors: Ambien CR (Sanofi), Edluar (Sandoz), and generic Zolpidem formulations.
- Market share: Generics dominate over 70% of the Zolpidem ER market in the U.S.
- Annual sales (2022): Estimated at $900 million for Zolpidem ER products, with generics accounting for over 80%.
Demand Factors
- Increasing prevalence of insomnia, especially among aging populations.
- Growing preference for extended-release formulations for better sleep maintenance.
- Cost sensitivity: Generics capture price-sensitive segments, while branded products retain premium pricing for specific indications or formulations.
Regulatory and Reimbursement Environment
- The drug is available via FDA approval as a generic, with no specific REMS or usage restrictions.
- Medicare Part D coverage: Wide reimbursement, supporting broad access.
- Health insurance policies favor lower-cost generics, exerting downward pressure on prices.
Competitive Landscape
| Product Name |
Manufacturer |
Formulation |
Market Share (2022) |
Approximate Annual Revenue |
| Ambien CR |
Sanofi |
6.25, 12.5 mg (ER) |
~25% |
$600 million |
| Edluar |
Sandoz |
5, 10 mg SL tablets |
~5% |
$50 million |
| Generic Zolpidem ER |
Multiple (including Apotex) |
12.5 mg ER |
>70% |
$250 million (collectively) |
Price Trends and Projections
Historical Pricing
- 2019: Average wholesale price (AWP) per 30-count bottle of 12.5 mg ER: approximately $250.
- 2021: Prices declined to roughly $190 per 30-count due to increased generic competition.
- 2022: Further volume-driven price reductions; average wholesale prices hovered around $150.
Current Pricing
- Typical wholesale acquisition cost (WAC) for Apotex's NDC 00527-1282: approx. $140–$160 per 30-count bottle.
- Retail pharmacy pricing: varies by region but generally aligns with WAC plus markup.
Price Projection (Next 3 Years)
- 2023: Slight decrease expected, driven by expanded generic entry; prices around $140.
- 2024: Stabilization expected; prices may stabilize within $130–$140 as competition saturates.
- 2025: Potential price erosion to approximately $120–$130 due to increased generics and biosimilars entering markets.
Influencing Factors
- Patent expiry: No patent protection for the specific NDC, facilitating generic entry.
- Manufacturing costs: Cost reductions in generic manufacturing may further lower prices.
- Market penetration: Growing adoption of non-branded generics supports price declines.
- Regulatory changes: Potential FDA policy adjustments could influence market dynamics.
Market Entry and Revenue Outlook
- Entry barriers are low due to existing generic competition.
- Revenue projections indicate the product's contribution will decline as generics command a larger share.
- By 2025, branded prices could decline by 20–25%, with total revenues potentially decreasing by 15–20%.
Key Market Risks
- Price erosion driven by increased competition.
- Shifts in prescribing patterns favoring alternative sleep therapies.
- Policy reforms aimed at drug pricing transparency.
- Regulatory restrictions or safety alerts affecting demand.
Key Takeaways
- Market share: The generic Zolpidem ER segment is the dominant driver, with over 70% of sales.
- Pricing decline: Expected to plateau around $120–$130 by 2025.
- Revenue outlook: Declining trend consistent with increased generic supply and price competition.
- Competitive pressures: The presence of multiple generic manufacturers limits pricing power.
- Market growth: Limited due to mature status; primary driver remains maintained demand among existing patients.
FAQs
1. What factors most influence the price of NDC 00527-1282?
Market competition from other generics, manufacturing costs, and lack of patent protections are primary drivers.
2. How does the introduction of biosimilars affect the market?
While biosimilars generally impact biologics, for small molecules like Zolpidem, additional generics directly influence prices and market share.
3. What is the potential for price stabilization?
Prices are likely to stabilize over the next 1-2 years as market saturation occurs, with minimal fluctuations unless policy changes arise.
4. Are there regional variations in pricing?
Yes. Retail pharmacy pricing can vary widely based on regional formulary coverage, insurance contracts, and pharmacy markups.
5. How does this market compare to other sleep aids?
It faces similar pricing pressures and demand patterns as other prescription sleep aids such as Eszopiclone and Ramelteon, with generics dominating the market.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2022). Approved Drugs Database.
[3] Medispan. (2022). Wholesale Acquisition Cost Data.
[4] National Center for Health Statistics. (2022). Insomnia Prevalence Estimates.
