Last updated: February 23, 2026
What is NDC 52427-0661?
NDC 52427-0661 identifies a drug approved by the FDA. This code corresponds to Zolpidem Tartrate Extended-Release (ER) 12.5 mg, marketed under the brand name Ambien CR. It is prescribed primarily for insomnia.
Market Size and Usage
Prescription Volume
- Approximately 8 million prescriptions issued annually in the U.S.
- Usage concentrated among adults aged 45-65.
Competitive Landscape
- Main competitors include:
- Traditional immediate-release Zolpidem (e.g., Ambien 5 mg, 10 mg)
- Other sleep aids such as Eszopiclone and Ramelteon
- Proprietary patents for the ER formulation expired in 2020.
Key Market Drivers
- Growing prevalence of insomnia linked to aging populations
- Increasing off-label uses for anxiety and sleep disturbance
- Competitive pressure from generics and alternative therapies
- Regulatory changes affecting prescribing patterns
Current Pricing Environment
Wholesale Acquisition Cost (WAC)
- Estimated WAC for 30 tablets of 12.5 mg ER Zolpidem is approximately $140.
- Prices differ slightly based on pharmacy and health networks.
Reimbursement and Insurance
- Average cash price: $10-12 per tablet.
- Insurance reimbursement varies based on negotiated drug prices and copayment tiers.
Generic Competition
- Generic formulations have entered the market at substantially lower prices, approximately $1-3 per tablet.
Price Projections
Short-term (Next 12 months)
- Given the patent expiry, immediate price erosion is expected.
- Brand-name prices could decrease by 30-50%, with average prices around $70-100 for a 30-day supply.
- Generics will dominate the market, setting the price benchmark.
Mid-term (1-3 years)
- Price stabilization at lower levels, driven by generic market penetration.
- Brand name drugs continue to command premiums but at a reduced rate, approximately $50-70.
Long-term (3-5 years)
- Generic share expected to surpass 90% of prescriptions.
- Prices likely to stabilize near $1-3 per tablet, aligning with generic standards.
- Limited innovation or formulation changes may slow further price declines.
Factors Influencing Price Trends
- Regulatory and legal challenges to patent protections
- Insurance coverage policies encouraging generics
- Prescriber and patient preferences
- Patent litigation or exclusivity extensions
Potential Market Opportunities and Risks
Opportunities
- Growing insomnia prevalence supports sustained demand.
- Longer-acting formulations may expand market share.
- Strategic partnerships with insurance providers.
Risks
- Price erosion driven by generics.
- Market shift toward non-pharmacologic treatments.
- Regulatory reforms affecting reimbursements.
Summary Table
| Parameter |
Current |
Short-term Projection |
Mid-term Projection |
Long-term Projection |
| WAC (per 30 tablets) |
~$140 |
$70-100 |
$50-70 |
$1-3 (per tablet) |
| Market share (brand) |
Significant |
Declining |
Minimal |
Minimal |
| Price per tablet |
~$4.67 |
$2-3 |
$1.67-2.33 |
$0.03-0.10 |
Key Takeaways
- The patent expiration in 2020 precipitated significant price declines.
- Generics dominate the market, pushing prices down to near production costs.
- Short-term pricing remains volatile but trending toward lower levels.
- Long-term outlook features stabilized prices aligned with generic standards.
- Market growth will depend on sleep disorder prevalence and alternative therapies.
FAQs
How does patent expiry impact drug prices?
Patent expiry allows generic manufacturers to enter the market, increasing competition and decreasing prices.
What are the main competitors for NDC 52427-0661?
Generic Zolpidem ER, immediate-release Zolpidem formulations, Eszopiclone, and Ramelteon.
How can manufacturers maintain revenues post-patent expiration?
Diversify product lines, develop new formulations, and negotiate value-based reimbursement agreements.
What regulatory factors could influence future prices?
Patent litigation, changes in FDA approval processes, and policies on drug importation.
Is there potential for new indications that could boost demand?
Limited data supports off-label uses, but approved new indications are unlikely in the near term.
References
- IQVIA. (2022). Pharmaceutical Market Reports.
- FDA. (2020). Drug Approvals and Labeling.
- SSR Health. (2023). Drug Pricing and Market Shares.
- Medicare & Medicaid Services. (2022). Reimbursement Policies.
- Statista. (2022). Sleep Disorder Treatment Market.
