Last updated: February 16, 2026
Overview
NDC 00591-0844 corresponds to Suvorexant, marketed under the brand Belsomra. Approved by the FDA in 2014, it is indicated for the treatment of insomnia characterized by difficulty falling asleep and/or staying asleep.
Market Size and Demand Drivers
- Target Population: Adults with chronic insomnia; estimates suggest approximately 30-35% of US adults report sleep disturbances, with about 10-15% diagnosed with insomnia requiring pharmacological intervention.
- Market Penetration: Belsomra captures a niche segment due to its novel orexin receptor antagonism, avoiding adverse effects linked to sedative-hypnotics like benzodiazepines or Z-drugs.
- Competitive Landscape: Key competitors include zolpidem (Ambien), eszopiclone (Lunesta), and trazodone. Belsomra's differentiated mechanism appeals to prescribers cautious of dependency risks associated with older agents.
- Prescriptions and Sales Data (2022): U.S. prescription volume totaled approximately 2 million units; annual sales reached roughly $600 million. Rapid growth observed in the first three years post-launch, plateauing as market saturation occurs.
Pricing Trends and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $8 - $10 per tablet (10 mg strength; varies by supplier and pharmacy).
- Average Retail Price: Around $20 - $25 per prescription (30-day supply of 10 mg tablets).
- Medicare and Medicaid Reimbursements: Typically 70-80% of WAC, depending on formulary placement.
Price Evolution
- Initial Launch (2014-2016): WAC was around $12 per tablet; retail prices escalated due to limited competition.
- Competitive Pressures (Post-2016): Entry of generics or biosimilar agents could reduce prices. However, as of 2023, Belsomra remains branded, with no approved generics in the US.
Market Projection Considerations (2023-2028)
| Factor |
Impact on Market & Price |
Data/Notes |
| Generic Entry |
Likely to reduce prices |
No generics as of 2023; predicted entry within 3-5 years if patent protections are challenged. |
| Market Growth |
Slight increase in prescriptions |
Continued market penetration among refractory insomniacs; growth rate ~3-5% annually. |
| Prescriber & Patient Acceptance |
Influences sales volume |
Increasing awareness of orexin antagonists and favorable safety profile boost adoption. |
| Regulatory & Patent Status |
Affects pricing |
Patents expire between 2024-2026; exclusivity influences pricing power. |
Price Projection (Next 5 Years)
- Pre-Generic Prices (2023): WAC $8-10/tablet; retail $20-25 per 30-day supply.
- Post-Patent Expiry (2024-2026): WAC may decline 30-50%, reaching $4-6/tablet; retail prices may stabilize around $12-15.
- Market Competition Impact: The advent of generics could drop prices further, down to $2-3 per tablet within 2 years of generic entry.
Conclusion
The market for NDC 00591-0844 remains moderate with steady demand driven by insomniacs seeking alternatives to traditional sedatives. Price points are currently stable but could decline substantially post-patent expiry due to generic competition. Monitored regulation developments and patent challenges could accelerate pricing changes.
Key Takeaways
- Belsomra's current market valuation reflects moderate demand, with a price range of $8-$10 per tablet.
- The absence of generics in 2023 sustains higher prices, but impending patent expirations forecast a sharp decline.
- Prescriptions are expected to grow modestly, supporting steady revenue through 2028.
- Competitive dynamics and regulatory status significantly influence future prices.
- Market entry of biosimilars or alternative mechanisms might further affect the outlook.
FAQs
1. When will generics for NDC 00591-0844 likely enter the market?
Patent protections expire between 2024 and 2026; generic approval and entry could follow within 1-2 years post-expiry.
2. How does Belsomra compare price-wise with its competitors?
While Belsomra's retail cost is around $20-25 per 30-day supply, some Z-drugs like zolpidem may cost $10-15, influencing market share.
3. What factors could accelerate price reductions?
Patent challenges, increased generic approvals, and formulary preference shifts toward cost-effective alternatives.
4. How does market size impact pricing strategy?
A saturated market with slow growth limits premium pricing; expanding indications or formulations could change dynamics.
5. Are there any upcoming regulatory changes that could influence prices?
FDA reviews of biosimilars or new patent litigations could influence market entries and pricing strategies.
References
- FDA. "Suvorexant (Belsomra) - Highlights of Prescribing Information." 2014.
- IQVIA. "Prescription Drug Market Data." 2022.
- CMS. "Medicare Part D Drug Pricing." 2023.
- FDA Patent and Exclusivity Data. 2022.
- Analyst Reports. "Sleep Disorder Pharmacotherapy Market," 2023.
