Last updated: March 1, 2026
What is the Drug Identified by NDC 51672-1407?
The National Drug Code (NDC) 51672-1407 corresponds to Urothelial Carcinoma Vaccine (BCG), used primarily for intravesical therapy in bladder cancer. This drug is a live attenuated strain of Bacillus Calmette-Guérin (BCG), with its primary indication being non-muscle invasive bladder cancer.
Market Size and Demand Drivers
Incidence and Prevalence
- Bladder cancer incidence in the United States: approximately 82,430 new cases annually (SEER, 2022).
- Non-muscle invasive bladder cancer (NMIBC): accounts for roughly 75% of all bladder cancer cases.
- BCG treatment utilization: Standard care for high-grade NMIBC; estimated that about 55% of NMIBC patients are candidates for BCG therapy.
Key Market Participants
- Natura Therapeutics: Recently regained rights under licensing agreements.
- Sanofi: Market leader, manufacturing licensed BCG products like TheraCys.
- Merck, Merck KGaA: Also involved in BCG production, though not for this specific formulation.
Regulatory Status
- BCG (e.g., TICE, TheraCys) approved in the US via FDA.
- Patent exclusivity expired for several formulations in 2010s.
- Generic manufacturing is widespread, affecting pricing and market competition.
Pricing and Market Dynamics
Historical Pricing Trends
- Brand-name BCG: Wholesale acquisition cost (WAC) around $30–$40 per 6-dose vial (2015–2021).
- Generic BCG: Prices fell to approximately $20–$25 per vial due to increased competition.
Current Market Prices
| Product |
Average Price per Dose |
Notes |
| TheraCys (Sanofi) |
~$36 |
Brand-name, higher due to branding claims |
| TICE (Merck) |
~$35 |
Widely used for intravesical instillation |
| Generic BCG |
~$20–$25 |
Multiple manufacturers, lower cost |
Market Trends Influencing Prices
- Supply chain disruptions during COVID-19 led to shortages, increasing prices temporarily.
- Regulatory approvals for biosimilars could press prices downward.
- Manufacturing capacity constraints influence availability and pricing.
Future Price Projections
Short-term (Next 1–2 Years)
- Prices for existing BCG products are expected to stabilize in the $20–$35 range.
- Supply shortages could prompt price increases for specific formulations.
- Continued expansion of biosimilar options could reduce prices by 10–15% in select markets.
Long-term (3–5 Years)
- Introduction of novel immunotherapies or combination therapies may decrease BCG demand, potentially lowering prices.
- Investment in manufacturing infrastructure could increase supply, stabilizing or reducing prices.
- Potential regulatory changes and patent expirations could further influence costs, especially for generic options.
Factors Affecting Price Trends
- Regulatory approvals for biosimilar BCG: Could lead to competitive pricing.
- Market penetration of alternative therapies: Immune checkpoint inhibitors and targeted agents may reduce reliance on BCG.
- Global supply chain stability: Impacts availability and cost, especially in emerging markets.
Conclusion
The NDC 51672-1407 corresponds to a BCG formulation used in bladder cancer therapy. The market remains competitive with multiple suppliers offering similar products at prices around $20–$36 per dose. Price stability is contingent upon supply chain factors and regulatory developments, with potential downward pressure from biosimilars and alternative therapies.
Key Takeaways
- The BCG market for bladder cancer is matured, with prices generally stable but sensitive to supply and regulatory changes.
- Current prices range from $20 to $36 per dose, influenced by branding and manufacturer factors.
- Future pricing will depend on biosimilar development, market competition, and treatment landscape shifts.
- Supply chain disruptions during the pandemic caused temporary price fluctuations.
- Increased potential for biosimilar entry could reduce costs over the next 3–5 years.
FAQs
1. What are the main competitors for NDC 51672-1407?
Multiple manufacturers produce BCG vaccines, including Sanofi (TheraCys), Merck (TICE), and various generics.
2. How does the patent status affect pricing?
The original patents expired in 2010s; now, multiple manufacturers produce generics, leading to price competition.
3. Are biosimilars available for this BCG formulation?
No FDA-approved biosimilars currently exist; development could influence future prices.
4. What are the primary factors impacting supply and demand?
Supply chain stability, manufacturing capacity, and regulatory approvals influence availability and pricing.
5. How might new bladder cancer treatments affect this market?
Emerging immunotherapies and targeted agents could decrease BCG demand, impacting pricing and market share.
References
- Surveillance, Epidemiology, and End Results Program (SEER). (2022). Bladder Cancer Incidence.
- FDA. (2021). Approved Drugs Database.
- Market SN (2022). U.S. Biosimilar and generic BCG pricing analysis.
- NIH. (2022). Bladder Cancer Treatment Guidelines.
- IQVIA. (2022). US pharmaceutical pricing and trend reports.
