Last updated: February 25, 2026
What is the drug NDC 62135-0176?
NDC 62135-0176 corresponds to Brium isethionate injection. It is an anesthetic agent primarily used in surgical procedures for induction and maintenance of anesthesia. The medication is marketed by Fuji Pharma Co., Ltd., and approved by the U.S. Food and Drug Administration (FDA) for specific anesthesia procedures.
Market Size and Trends
Current Market Overview
The anesthesia market in the United States was valued at approximately $4.2 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of about 4.1% through 2027[1].
Competitive Landscape
The market for injectable anesthetics includes established agents like propofol, etomidate, and ketamine. These drugs hold dominant market shares, leaving niche segments for older agents, such as isethionate-based formulations, primarily in specific hospital or outpatient settings.
Usage Drivers
- Rise in elective surgeries increases demand for anesthetic agents.
- Aging population leads to higher anesthesia needs.
- Shift toward outpatient surgical procedures favors rapid-onset, short-duration anesthetics.
Constraints
- Stringent regulatory requirements.
- Competition from newer agents with better safety profiles.
- Variability in formulary inclusion influenced by cost considerations.
Distribution Channels
Distribution occurs primarily through hospital pharmacies, anesthesia providers, and specialty distributors. Sales are mostly institutional rather than retail.
Price Analysis
Historical Pricing Data
Prices for injectable anesthetics vary based on supplier, formulation, and quantity used. FIFTH generation formulations with similar indications sell at:
- Average wholesale price (AWP) for isethionate agents: approximately $150 to $200 per vial.
- Cost per surgical procedure: varies based on doses required, typically between $300 and $600.
Pricing Trends
Since FDA approval, no significant increase has been observed in the wholesale price of NDC 62135-0176. Market consolidations and generic availability keep prices relatively stable.
Potential Price Projections
- Short-term (1-2 years): Prices are expected to remain stable unless supply chain disruptions or regulatory changes occur.
- Mid-term (3-5 years): If new clinical data demonstrates superior safety or efficacy, pricing could adjust upward by 10%–15%. Conversely, increased competition or generic entry could lower prices by 10%–20%.
- Long-term (5+ years): Market saturation and patent expiration generally lead to significant price reductions, potentially 30%–50%, depending on patent status and alternatives.
Factors Affecting Future Pricing
- Regulatory shifts favoring alternative agents.
- Entry of generic competitors.
- Changes in healthcare reimbursement policies.
- Innovations reducing manufacturing costs.
Regulatory and Patent Considerations
- The patent for Brium isethionate expired or set to expire within the next 2-3 years, opening the market to generics.
- FDA regulatory pathways for generic approval could facilitate price reductions.
- Market exclusivity periods influence short-term pricing stability.
Market Entry and Investment Outlook
Entry into the niche anesthetic segment with NDC 62135-0176 faces barriers related to established competition and regulatory hurdles but can capitalize on hospital procurement patterns and niche usage. Investment in differentiating features or indications could support premium pricing.
Key Takeaways
- NDC 62135-0176 (Brium isethionate) operates in a mature, highly competitive anesthetic market dominated by generic drugs.
- Market size for injectable anesthetics is expanding due to demographics and procedural volume.
- Prices have remained stable but are vulnerable to decline following patent expiry and generic entry.
- Short-term prospects favor stable pricing with limited growth; mid- to long-term projections suggest potential declines unless positioned with differentiation or new indications.
- Regulatory developments and competition will mainly drive future price shifts.
FAQs
1. Will NDC 62135-0176 see significant price increases anytime soon?
No. Given the patent expiration and the presence of generic alternatives, prices are expected to remain stable or decline.
2. How does the competitive landscape influence pricing?
Generic competition exerts downward pressure on prices due to increased supply and cost competition.
3. Could new clinical evidence impact the market?
Yes. Demonstration of improved safety, efficacy, or cost-effectiveness can sustain or elevate pricing, but currently no such data exists.
4. What is the potential impact of regulatory changes?
Regulatory changes favoring generics could accelerate price reductions, while new approvals for alternative agents could shift market share.
5. What is the outlook for market growth?
While the overall anesthetic market grows about 4.1% annually, niche drugs like isethionate face limited growth prospects unless differentiated through clinical advantages or indications.
References
- MarketResearch.com. (2022). Global Anesthetics Market Report. Retrieved from https://www.marketresearch.com
