Last updated: March 13, 2026
What is the drug associated with NDC 35573-0436?
The NDC 35573-0436 refers to Suvorexant (brand name: Belsomra), approved by the FDA in August 2014. It is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
What is the current market landscape for Suvorexant?
Suvorexant faces competition primarily from other prescription sleep aids, including benzodiazepines (e.g., temazepam), non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone), and newer drugs like lemborexant.
Market Size Overview
- The global sleep aids market was valued at approximately USD 4.9 billion in 2022.
- Compound annual growth rate (CAGR) from 2023 to 2028 projected at 6.7% (Research & Markets, 2022).
- U.S. prescription volume for sleep aids in 2022 exceeded 10 million prescriptions, with Suvorexant accounting for an estimated 8-10% of the market share.
Revenue Estimates in the U.S.
- Estimated retail sales of Suvorexant in 2022: USD 600 million.
- Market share among prescription sleep aids: Approximately 9-10%.
- Major competitors include zolpidem and eszopiclone, with market shares of roughly 35% and 20%, respectively.
Key Drivers and Barriers
-
Drivers:
- Increasing prevalence of chronic insomnia linked to aging populations.
- Growing preference for prescription medications over OTC options.
- Development of formulations with improved sleep maintenance effects.
-
Barriers:
- Side effect profile, including next-day sedation and complex dosing.
- Insurance coverage limitations impacting affordability.
- Patient and clinician familiarity with existing therapy options.
How are prices evolving for NDC 35573-0436?
Current Pricing Data
- The average wholesale price (AWP) for Suvorexant (10 mg, 30-count tablet) ranges from USD 200 to 230.
- The average patient out-of-pocket cost varies from USD 10 to USD 25, depending on insurance.
Pricing Trends
| Year |
Approximate AWP (USD) |
Market Positioning |
| 2015 |
210 |
Initial launch phase; high initial prices |
| 2018 |
220 |
Stable, slight increase, competitive dynamics |
| 2022 |
225 - 230 |
Stabilization; no significant discounting |
Price comparisons
Compared to other sleep aids:
- Zolpidem (generic): USD 30-50 for a 30-day supply.
- Eszopiclone (generic): USD 70-90 for a 30-day supply.
- Lemborexant (brand: Dayvotion): USD 250-300 for a 30-day supply.
Note: Suvorexant's higher price reflects its branded status and newer market entry.
Future price projections
Factors influencing future pricing
- Patent expiry: Suvorexant’s patent protection lasts until 2024 in the U.S.
- Generic competition: Introduction of generics expected post-2024 could reduce prices by 40-60%.
- Market penetration: Increased awareness and insurance coverage could sustain or grow retail pricing.
Projected price trajectory (2023-2028)
| Year |
Estimated AWP (USD) |
Comment |
| 2023 |
230 |
Stable with limited generic competition |
| 2024 |
150 - 180 |
Crossroads of patent expiry; price decline begins |
| 2025 |
120 - 160 |
Increased generic competition, price erosion accelerates |
| 2026 |
100 - 140 |
Market saturation; further discounts expected |
| 2027 |
80 - 120 |
Continued generic availability, lower margins |
| 2028 |
70 - 100 |
Dominance of generics consolidates pricing |
Key takeaways
- The global sleep aids market is expanding at a CAGR of 6.7%, with Suvorexant holding a significant share within prescription sleep medications.
- Current retail prices are stable but expected to decline sharply after patent expiry in 2024.
- Generic entry will likely result in a 40-60% price reduction over the next two years.
- Price competition and increasing market penetration could further lower costs.
- Companies should prepare for price erosion post-generic launch while exploring strategic positioning via formulary negotiations and indications expansion.
FAQs
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What factors impact Suvorexant’s market share?
Market share depends on efficacy perception, side effect profile, insurance coverage, and competitor developments.
-
When will generics enter the market?
Patent expiry in the U.S. is scheduled for 2024, enabling generic manufacturers to launch equivalents.
-
Are there any upcoming formulations or indications?
No current approvals for additional indications; future formulations could aim to improve tolerability and dosage convenience.
-
How does Suvorexant’s pricing compare internationally?
European and Asian countries typically see lower prices due to different healthcare systems, with discounts of 20-50% compared to U.S. prices.
-
What does this mean for investors?
Investment risk diminishes post-2024 with generic entry but may be offset by increased demand ahead of patent expiry and potential new indications.
Sources
[1] Grand View Research. (2022). Sleep Aids Market Size, Share & Trends.
[2] IQVIA. (2022). Prescription Data Analysis.
[3] U.S. Food and Drug Administration. (2014). FDA approval for Belsomra.
[4] Morningstar. (2022). Prescription drug pricing report.
[5] Research & Markets. (2022). Sleep aids market forecast.
