Last updated: February 25, 2026
What Is the Drug Classified Under NDC 67877-0451?
The National Drug Code (NDC) 67877-0451 corresponds to Remimazolam, marketed under the brand name CNS 1187 by Acacia Pharma. It is a short-acting benzodiazepine used as an intravenous sedative and anesthetic for procedural sedation and induction of anesthesia.
Market Context
Remimazolam entered the US market around 2021, targeting procedural sedation, notably in surgeries, endoscopies, and intensive care settings. It competes mainly with other sedatives such as midazolam, dexmedetomidine, and propofol.
Current Market Size
In 2022, the US procedural sedation market was valued at approximately USD 2.5 billion, projected to grow at a compound annual growth rate (CAGR) of 6% through 2030. The market segment for benzodiazepine derivatives accounted for roughly 20% of this total, driven by increasing procedural volume and adoption of newer sedative agents like remimazolam.
Key factors influencing market size:
- Growing procedural volume: Increasing outpatient surgeries and minimally invasive procedures.
- Enhanced safety profile: Remimazolam's rapid recovery and reduced respiratory depression.
- Market penetration: Limited current competition but potential for significant uptake in specific clinical areas.
Competitive Landscape
Major competitors include:
- Midazolam (marketed as Versed, generic)
- Propofol (various brands)
- Dexmedetomidine (Precedex)
Remimazolam's competitive advantages are its reversibility with flumazenil and favorable safety profile, but its market share remains modest as clinicians transition from established agents.
Price Projections
Current Pricing (2023)
Remimazolam's average wholesale price (AWP) per vial (~ 5 mg) ranges between USD 45-60. Administration costs are not included.
| Drug |
Price per Vial (USD) |
Usage Notes |
| Remimazolam |
50 |
Estimated average wholesale price. Can vary by distributor and region. |
| Midazolam |
2-5 |
Significantly lower cost but used off-label for certain indications. |
| Propofol |
15-25 |
Widely used, generic, lower cost. |
Short-Term Price Projection (2023–2025)
- Market acceptance: Expected steady increase in adoption in specific procedural settings.
- Pricing trend: Slight decrease (~5-10%) in wholesale prices due to increased competition from generics and manufacturing efficiencies.
- Projected price per vial (2025): USD 45-50.
Long-Term Price Outlook (2025–2030)
- Market penetration: Will determine pricing stability; significant adoption may maintain or slightly increase prices due to supply constraints or patent exclusivity periods.
- Potential price adjustments: Entry of biosimilars or generics could further reduce prices, potentially by 20-30% over five years.
- Estimated price per vial (2030): USD 35-45 if generic competition increases; may stabilize higher if remimazolam maintains a niche or exclusive market position.
Regulatory and Market Entry Factors
- FDA approval: Received in 2020, approval extension to anesthetic and ICU sedation indications followed.
- Reimbursement policies: Steady reimbursement out of anesthesia provider payers will influence uptake.
- Physician adoption: Training and familiarity impact speed of market penetration.
- Patent landscape: No active patents beyond initial exclusivity, promoting generics entry around mid-to-late 2020s.
Regional and Global Outlook
- North America: Primary market, with prices reflecting US healthcare payer dynamics.
- Europe and Asia: Entry expected within 2-4 years, with pricing potentially 10-20% lower due to different regulatory and reimbursement systems.
Key Variables Affecting Market and Pricing
| Variable |
Impact |
| Competitive launches |
Lower prices, increased market share for generics. |
| Clinical preference shifts |
Faster adoption of remimazolam could sustain or increase prices. |
| Patent litigation or extensions |
Delay generic entry, keeping prices higher longer. |
| Healthcare policy changes |
Reimbursement adjustments influence market access and pricing. |
Summary
Remimazolam's market size remains limited but expanding, driven by procedural demand and safety attributes. Prices are expected to decline moderately in the near term, with stabilization or modest increases in the mid to long-term, depending on market acceptance, competition, and regulatory factors.
Key Takeaways
- Current wholesale price per vial: USD 50 (~5 mg).
- Market growth driven by procedural volume and safety profile.
- Prices likely to decrease by 10-15% over 2 years; stabilize or decline further with generic competition.
- Market entry in Europe and Asia expected between 2023-2027 at slightly lower prices.
- Pricing pressures will increase as biosimilars and generics enter the market.
FAQs
1. What factors influence remimazolam's price compared to older sedatives?
Market penetration, patent status, manufacturing costs, and competition from generics directly influence pricing. Clinical advantages may sustain higher prices initially.
2. How quickly will generics likely enter the market?
Patent exclusivity typically lasts 5-7 years post-approval. Generic versions could enter around 2025-2027, potentially reducing prices by 20-30%.
3. Is remimazolam cost-effective for healthcare providers?
Its safety and rapid recovery profile may reduce procedure times and adverse events, offsetting higher drug costs compared to older agents.
4. What regions present opportunities for market expansion?
Europe and Asia show emerging interest, with regulatory approvals anticipated in the next 2-4 years, offering expansion potential.
5. How might policy changes affect pricing strategies?
Reimbursement changes, value-based purchasing, or price controls could pressure prices downward, especially in government-funded healthcare systems.
References
[1] IQVIA. (2022). US Pharmacy Market Data.
[2] FDA. (2021). Remimazolam New Drug Application Approval Documentation.
[3] Grand View Research. (2023). Sedative Market Size and Forecast.
[4] Pharma Intelligence. (2022). Global Drug Price Trends.
[5] DrugBank. (2023). Remimazolam Profile.
