Last updated: February 27, 2026
What is the drug associated with NDC 43547-0458?
The National Drug Code (NDC) 43547-0458 corresponds to Remimazolam Tosylate Injection. It is an ultra-short-acting benzodiazepine used primarily as an anesthetic agent for procedural sedation and general anesthesia.
Market Overview
The remimazolam market is currently niche but expanding, driven by regulatory approval and expanding indications. Since its initial FDA approval in 2020 for procedural sedation, the drug has gained traction in hospitals and outpatient procedures.
Key Applications
- Sedation during endoscopy
- Induction and maintenance of general anesthesia
- Procedural sedation outside operating rooms
Competitive Landscape
Remimazolam's primary competitors include:
- Midazolam
- Propofol
- Dexmedetomidine
Major pharmaceutical companies involved:
- Japan's PAION AG (original developer)
- Acacia Pharma (marketed in select regions)
- Newly entering generic manufacturers post-patent expiry (if applicable)
Market Size (2022–2023)
Global anesthesia agents market was valued at approximately $11 billion in 2022, with benzodiazepines accounting for roughly 20% of anesthesia drug consumption in hospitals. The specific segment for remimazolam is smaller but gaining share rapidly.
In the U.S., procedural sedation drugs, including remimazolam, are estimated to constitute about $2 billion annually.
Pricing History and Projections
Current Pricing
- Brand Name: Acacia's Byfavo (USA) priced around $350–$400 per vial (100 mg).
- Hospital Acquisition Cost: Approx. $250–$350 per vial, depending on volume discounts.
- Generic Options: If generics enter the market, prices could decrease by 30–50%.
Price Dynamics and Factors
| Factor |
Impact on Price |
Specifics |
| Patent Status |
Price stability or decline |
As of 2023, patent protections hold in many regions, limiting generics. |
| Competition |
Price decrease |
Entry of generics expected within 3–5 years, likely reducing prices. |
| Volume |
Price reduction |
Bulk hospital purchasing can lower per-unit costs. |
| Regulatory Approvals |
Market expansion |
Broader approvals increase willingness to pay. |
Price Projections (Next 5 Years)
| Year |
Expected Trend |
Notes |
| 2023 |
Stabilization |
Current prices maintained with limited generic competition. |
| 2024–2025 |
Moderate decline |
Entry of first generics depresses prices by 20–30%. |
| 2026–2027 |
Further decline |
Widespread generic availability, prices may fall 40–50% from peak brand prices. |
| 2028+ |
Market maturation |
Prices stabilize at approximately $150–$250 per vial, with regional variations. |
Revenue Projections
Assuming the following:
- 2023: 1 million vials sold in the U.S., average price $350.
- Growth rate: 10% annually in units sold.
- Price decrease: 25% by 2026 due to generics.
Estimated Revenue (USD):
| Year |
Units Sold |
Average Price |
Revenue |
| 2023 |
1,000,000 |
$350 |
$350 million |
| 2024 |
1,100,000 |
$330 |
$363 million |
| 2025 |
1,210,000 |
$315 |
$381.15 million |
| 2026 |
1,331,000 |
$262.50 |
$349.43 million |
Note: These projections depend heavily on patent duration, market acceptance, and regulatory pathways.
Key Market Risks
- Patent expiration: Accelerates generic entry and price erosion.
- Regulatory decisions: Delays or restrictions can impact sales.
- Competitive alternatives: Advances in other anesthetic agents may reduce demand.
- Off-label use: Limited data may restrict broader application.
Conclusion
Remimazolam (NDC 43547-0458) is positioned for moderate growth in the anesthesia market, with prices expected to decline as patents expire and generics enter the market. Current prices are approximately $350–$400 per vial, with a potential decrease to $150–$250 in five years. Revenue growth hinges on expanding indications and institutional adoption.
Key Takeaways
- The drug is primarily used for procedural sedation and anesthesia, competing against midazolam and propofol.
- Market size in the U.S. is roughly $2 billion annually; remimazolam accounts for a small but growing share.
- Prices currently range around $350–$400 per vial, with predicted declines due to generic competition.
- Revenue projections indicate steady growth in unit sales, offset by price declines post-patent expiry.
- Market risks include patent expirations, competition, regulatory hurdles, and off-label restrictions.
FAQs
-
When will generics for remimazolam become available?
Likely within 3–5 years post-patent expiration, depending on patent litigation and regulatory approval timelines.
-
What regions are the main markets for remimazolam?
North America, Europe, and parts of Asia. The U.S. has the largest market.
-
How does remimazolam compare price-wise to midazolam?
Midazolam costs approximately $0.50–$2 per dose, significantly cheaper than remimazolam, which is priced around $350–$400 per vial.
-
What factors influence remimazolam's market growth?
Regulatory approvals, clinical adoption, expansion of indications, and competition from alternative agents.
-
Are there approved biosimilars or generic versions?
As of 2023, no biosimilars or generics are approved; market entry is anticipated post-patent expiry.
References
[1] MarketWatch. (2023). Global anesthesia drugs market size.
[2] FDA. (2020). Remimazolam approval details.
[3] IQVIA. (2023). Hospital and clinic procurement data.
[4] Acacia Pharma. (2023). Pricing and product information.
[5] Deloitte. (2022). Impact of patents on drug pricing.
