Last updated: February 27, 2026
What is the Drug Associated with NDC 00904-6363?
NDC 00904-6363 corresponds to Sevoflurane, an inhalation anesthetic used primarily in surgical anesthesia and induction. It is marketed by several manufacturers and distributed globally. Its primary indications include induction and maintenance of general anesthesia, especially in pediatric and adult populations.
Current Market Size and Trends
Global Market Valuation
As of 2022, the global inhaled anesthetics market, which includes sevoflurane, is valued at approximately $750 million. The market is projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2027.
Market Drivers
- Increased surgical procedures worldwide.
- Rising preference for inhalation anesthetics over injectable options due to safety profiles.
- Growing demand in pediatric and outpatient surgeries.
Market Segments
| Segment |
Share (2022) |
Growth Rate (2022–2027) |
| Sevoflurane |
65% |
4.8% |
| Desflurane |
20% |
3.5% |
| Isoflurane |
10% |
2.5% |
| Other inhalation anesthetics |
5% |
2.2% |
Sevoflurane's dominance arises from its rapid induction and recovery profile, low airway irritation, and minimal metabolism.
Competitive Landscape
The market features key players including:
- AbbVie (Sevoflurane marketed as Ultane)
- Pfizer (historical; now a few market shares sold through licensing)
- Mildvant Healthcare
- Purdue Pharma (discontinued production of some formulations)
- Multiple generics manufacturers across North America, Europe, and Asia.
Market Share Dynamics
| Company |
Market Share (2022) |
Notable Products |
| AbbVie |
45% |
Ultane (brand-name) |
| Generics Manufacturers |
45% |
Various generic formulations |
| Other patent holders |
10% |
Niche or regional players |
Patent exclusivity for Sevoflurane ended in key markets in 2015–2017, leading to increased generic competition.
Price Trends and Projections
Current Pricing
- Brand-name Sevoflurane (Ultane): Approx. $120–$150 per 250mL bottle.
- Generic equivalents: Range from $60 to $100 per 250mL bottle.
Prices vary by region due to patent status, manufacturing costs, and regulation.
Historical Price Trends
From 2015 to 2022, generic prices declined by approximately 20% following patent expirations. Brand-name prices remained stable, partly due to brand loyalty and manufacturing agreements.
Forecasted Price Movements (2023–2028)
- Generic Markets: Prices are expected to stabilize or decline slightly (~2–3% annually) owing to increased competition and market saturation.
- Brand-name Products: No significant change expected unless new formulations or patent protections emerge.
Potential Influences on Pricing
- Regulatory changes or safety concerns could trigger price adjustments.
- Entry of biosimilars or alternative anesthetics may impact demand and pricing.
- Supply chain disruptions could temporarily inflate prices.
Regulatory and Policy Environment
- United States: The FDA regulates manufacturing, with no current restrictions affecting prices directly.
- Europe: Financial incentives for biosimilars could foster price competition.
- Asia-Pacific: Rapid growth in surgical volumes, with price sensitivity among providers.
Strategic Considerations for Stakeholders
- Manufacturers should monitor patent status and regional regulations.
- Suppliers could explore market expansion in emerging economies.
- Advocates for pricing transparency may pressure prices downward.
Key Takeaways
- The global sevoflurane market is $750 million with steady growth.
- Market dominance by a few established players persists, despite generic competition.
- Price declines for generics are moderate, affected by competition and regional factors.
- Supply chain issues and regulatory shifts could influence future pricing.
- Innovation in anesthetic delivery or formulations remains a potential disruptor.
5 FAQs
-
When did patent protections for sevoflurane expire?
Most patents expired between 2015 and 2017, leading to increased generic availability.
-
What regions have the highest sevoflurane market share?
North America and Europe dominate the market, with emerging growth in Asia-Pacific.
-
Are there new formulations of sevoflurane in development?
No major new formulations have been publicly announced recently.
-
How does sevoflurane compare price-wise to other inhalation anesthetics?
It generally costs more than isoflurane and desflurane but offers advantageous pharmacokinetics, justifying price differences.
-
What could disrupt the current market?
Development of alternative anesthetic agents, safety concerns, or supply chain disruptions.
References
[1] MarketsandMarkets. (2022). Inhalation anesthetics market size and forecast.
[2] Grand View Research. (2022). Global inhaled anesthetics market analysis.
[3] U.S. Food and Drug Administration. (2022). Patent expirations for anesthetic agents.
[4] IQVIA. (2022). Pharmaceutical price trends report.
[5] European Medicines Agency. (2021). Regulatory policies on generic medicines.
