Last updated: March 12, 2026
What Is NDC 00603-2553?
NDC 00603-2553 corresponds to a specific pharmaceutical product listed in the National Drug Code system. According to the FDA's NDC Directory, this code denotes Bupivacaine HCl Injectable Solution, 0.75%. It is a local anesthetic used primarily in surgical procedures, pain management, and obstetric anesthesia.
Market Size and Demand
Current Market Overview
- Market Need: Bupivacaine is a widely used local anesthetic in hospitals, outpatient surgical centers, and dental practices.
- Sales Volume: Based on IMS Health and IQVIA data, the US market for bupivacaine injectable solutions was approximately $350 million in 2022.
- Distribution: Major suppliers include Pfizer, Hikma, B. Braun, and Hospira.
- Utilization Trends: Steady growth driven by continued surgical procedures and expanding outpatient care.
Competition and Supply
- Top Competitors: Pfizer (Marcaine), Hikma (Serniva), B. Braun, and Sandoz.
- Market Share Distribution: Pfizer holds an estimated 40-50%, with the remainder split among generics.
- Manufacturing Scalability: Sizable capacity in the US and Europe supports stable supply; recent supply chain disruptions have been minimal.
Regulatory Status and Patent Considerations
- Patent Status: The original patent expired in 2004; multiple generics are approved.
- FDA Approvals: No recent or upcoming exclusivity periods expected; the product is on standard approval status.
- Labeling: Widely accepted, with no major pending label changes affecting market competitiveness.
Price Trends and Projections
Historical Price Dynamics
- Average Wholesale Price (AWP): The AWP for 10 mL vials has hovered around $15-25 over the past five years.
- Wholesale Acquisition Cost (WAC): Generally lower than AWP, averaging $10-20.
- Reimbursement: Medicaid and Medicare typically reimburse at or near WAC; commercial insurers often negotiate discounts below AWP.
Current Pricing Landscape
| Metric |
Approximate Price (per 10 mL vial) |
Notes |
| Wholesale Acquisition Cost (WAC) |
$12 |
Price range for bulk purchasing |
| Average Wholesale Price (AWP) |
$20 |
Retail estimate |
| Medicaid Reimbursement |
$14 |
Reflects negotiated rates |
Future Price Projections (Next 5 Years)
- Inflation Adjustment: Prices are expected to grow 1-3% annually, reflecting supply chain costs and regulatory compliance.
- Market Competition Impact: Entry of low-cost generics could press prices downward.
- Supply Chain Factors: Potential disruptions due to geopolitical issues or raw material shortages could inflate costs temporarily.
| Year |
Projected WAC Price |
Assumptions |
| 2023 |
~$13 |
Stabilized supply chain, moderate inflation |
| 2024 |
~$14 |
Slight increase, increased demand |
| 2025 |
~$14.50 |
Market saturation, price stabilization |
| 2026 |
~$15 |
Continued demand, regulatory stability |
| 2027 |
~$15.50 |
Low inflation, stable supply |
Market Entry and Competitive Strategies
- Generic Entry: Additional generic manufacturers could lower prices; recent approvals suggest ongoing market entry.
- Pricing Strategies: Manufacturers often employ tiered pricing based on procurement volume and buyer type.
- Regulatory Barriers: Minimal; standard approval pathways do not restrict new entrants.
Key Market Drivers
- Growing outpatient and ambulatory surgical procedures.
- High recurrence of demand due to the drug’s safety profile and efficacy.
- Price sensitivity among payers and hospitals.
-Closer scrutiny of procurement contracts and preferred supplier lists.
Risks and Challenges
- Price erosion due to increased generic competition.
- Raw material costs may rise, influencing manufacturing expenses.
- Potential regulatory changes or new formulation approvals could affect market dynamics.
Summary
The market for Bupivacaine HCl injectable solutions remains stable with slow growth projected. Pricing is expected to incrementally increase, influenced by supply chain stability and minimal patent protections. Generics have driven price competition; therefore, aggressive pricing strategies are critical for new entrants. Supply chain disruptions and raw material costs remain potential risk factors.
Key Takeaways
- The product’s market size is approximately $350 million in the US.
- Price projections suggest a gradual increase to ~$15.50 WAC per 10 mL vial by 2027.
- Competition from generics shapes pricing dynamics, with wholesale prices averaging around $12.
- Regulatory environment remains permissive; no major patent protections influence market exclusivity.
- Market growth driven by continued use in outpatient surgical procedures and pain management.
Frequently Asked Questions
-
What are the main competitors for NDC 00603-2553?
Pfizer (Marcaine), Hikma (Serniva), B. Braun, and Sandoz.
-
How is the price of bupivacaine expected to change in the next five years?
It is projected to rise by approximately 1-3% annually, reaching about $15.50 WAC per 10 mL vial by 2027.
-
Are there significant patent protections affecting this drug?
The original patent expired in 2004, enabling multiple generic manufacturers.
-
What factors could lead to price declines?
Entry of new generic manufacturers, increased competition, raw material cost reductions.
-
What is the volume of the US market for this product?
Estimated at around $350 million annually, with consistent demand from hospitals and clinics.
References
[1] U.S. Food and Drug Administration. (2023). National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
[2] IQVIA. (2022). Market Intelligence Report – Injectable Local Anesthetics.
[3] Medicaid & Medicare Reimbursement Data. (2022). Managed Markets Institute.
[4] Pfizer Inc. (2023). Marcaine Product Label. Retrieved from https://labeling.pfizer.com/labeling/009963
[5] Sandoz. (2023). Bupivacaine Generic Approvals. FDA Database.
