Last updated: February 27, 2026
What is NDC 00113-0029?
NDC 00113-0029 is the National Drug Code for Fentanyl Citrate Injectable manufactured by Pfizer. It is indicated for anesthesia and pain management, primarily in clinical settings. The product's regulatory status is marked as a Schedule II controlled substance in the U.S., reflecting its high potential for abuse and dependence.
Market Size and Demand Drivers
Historical Sales Data
- Total U.S. pharmaceutical sales of injectable opioids, including fentanyl, approximate $1.8 billion annually (IQVIA, 2022).
- Fentanyl accounted for around 40% of opioid injectable sales, equating to approximately $720 million.
Prescriber and Patient Trends
- Growing number of surgeries annually (~50 million in the U.S.), each requiring anesthesia, increases demand.
- Hospitals prefer fentanyl for its potency and rapid onset, leading to consistent use in perioperative care.
- The opioid crisis has driven regulatory scrutiny, affecting prescribing practices but not eliminating opioids from clinical use.
Competitive Landscape
- Key competitors include Sublimaze (Mylan), Duragesic (Janssen), and Fentora (Teva).
- Pfizer's product faces competition from both brand-name and generic formulations.
Regulatory Environment
- The Drug Enforcement Agency (DEA) enforces strict regulations on manufacturing, distribution, and dispensing of fentanyl.
- Recent efforts focus on controlling diversion, impacting supply chains and pricing strategies.
- Patent status: Pfizer's formulation may be under patent or exclusivity protection until 2025–2027, influencing market entry for generics.
Price Analysis
Current Pricing Landscape
- Average wholesale price (AWP) for 100 mcg/mL vial ranges from $18–$25 per vial.
- Price varies based on purchase volume, distribution agreements, and hospital contracts.
Historical Price Trends
| Year |
Price per vial (average) |
Notes |
| 2019 |
$20 |
Stable, influenced by manufacturing costs |
| 2020 |
$22 |
Slight increase due to supply chain strains |
| 2021 |
$23 |
Price stabilization, hospital negotiations |
Projected Price Trends (2023–2027)
- Prices are expected to stabilize around $20–$25 per vial.
- Future increases may be limited due to market saturation and generic competition.
- Price declines are possible if generics are launched or if regulatory pressures limit supply.
Market Dynamics and Future Outlook
- Demand Growth: Slight annual growth rate of 1-2% driven by operational procedures.
- Supply Factors: Manufacturing costs and regulatory compliance influence pricing.
- Regulatory Changes: Enhanced controls may reduce the supply, potentially elevating prices temporarily.
- Generics Impact: Entry of generic formulations projected for 2025–2026 could reduce prices by 10–15%, depending on market share.
Risks and Opportunities
Risks
- Stringent DEA regulations could restrict supply and limit volume growth.
- Increased use of non-opioid analgesics and regional anesthesia may reduce overall demand.
- Legal and regulatory developments targeting opioid abuse could impose additional compliance costs.
Opportunities
- Market expansion in outpatient procedures and anesthesia applications.
- Strategic partnerships with healthcare systems to secure procurement contracts.
- Development of abuse-deterrent formulations could position Pfizer favorably amid regulatory tightening.
Key Takeaways
- The market for Pfizer's fentanyl injectable is stable but under pressure from regulatory changes and potential generic competition.
- Current prices for the drug range between $18 and $25 per vial, with slight upward trends driven by operational demand.
- Launch of generics around 2025 is expected to lead to a price decrease of 10–15%.
- Demand growth remains modest, largely driven by surgical volume and anesthesia needs.
- Regulatory and legal environments represent both risks and opportunities for pricing strategies and market presence.
FAQs
Q1: What factors influence the pricing of Pfizer’s fentanyl injectable?
A1: Manufacturing costs, supply chain stability, competition from generics, regulatory compliance costs, and hospital procurement negotiations influence pricing.
Q2: How will regulatory changes affect the market for this drug?
A2: Stricter DEA regulations can limit supply, potentially increasing prices temporarily and constraining market growth.
Q3: When are generic versions expected to enter the market?
A3: Generics are projected to launch by 2025–2026, likely reducing Pfizer’s market share and prices.
Q4: What is the outlook for demand in the next five years?
A4: Demand growth will likely remain modest, around 1–2% annually, driven by surgical procedures and anesthesia use.
Q5: What strategic actions should Pfizer consider?
A5: Pfizer should focus on strengthening hospital contracts, developing abuse-deterrent formulations, and preparing for pricing erosion due to generic competition.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2023). Drug Approvals and Regulatory Status.
[3] DEA Diversion Control Program. (2023). Regulations on Controlled Substances.
