Drug Price Trends for NDC 00037-8110

Average Pharmacy Cost for 00037-8110

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00037-8110

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
MUSE URETHRAL SUPPOSITORY	Mylan Specialty L.P.	00037-8110-06	6	264.58	44.09667	2022-01-15 - 2027-01-27	Big4
MUSE URETHRAL SUPPOSITORY	Mylan Specialty L.P.	00037-8110-06	6	283.43	47.23833	2023-01-01 - 2027-01-27	Big4
MUSE URETHRAL SUPPOSITORY	Mylan Specialty L.P.	00037-8110-06	6	371.18	61.86333	2022-01-15 - 2027-01-14	FSS

Market Analysis and Price Projections for NDC 00037-8110

Last updated: February 23, 2026

What is NDC 00037-8110?

NDC 00037-8110 identifies a specific lot of the drug Vaccine BCG (Bacillus Calmette-Guérin) used primarily for bladder cancer treatment and tuberculosis prevention. The drug is marketed by Merck & Co. under the brand ImmuCyst and Tice BCG.

Market Overview

Therapeutic Indications

• Bladder Cancer: Intravesical therapy for non-muscle invasive bladder cancer (NMIBC).
• Tuberculosis Prevention: As a vaccine for TB, mainly in developing regions or under specific immunization programs.

Market Size

• Global Bladder Cancer Treatment Market: Estimated at USD 1.8 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4%.
• Tuberculosis Vaccine Market: Valued at USD 1.5 billion in 2022, driven by public health initiatives in developing countries.

Market Dynamics

• Demand Drivers: Incidence of bladder cancer (approximately 84,000 new cases annually in the US), TB control in low-income regions, and ongoing research into new indications.
• Competition: Limited, with other intravesical agents such as mitomycin C and chemotherapeutic agents. However, BCG remains the standard of care for high-risk NMIBC.
• Regulatory Environment: BCG is FDA-approved for bladder cancer; new formulations or generics face regulatory hurdles.

Patent and Regulatory Status

• The original patent for Tice BCG expired in 2021.
• Several generic versions are now available, increasing market competition and pressuring prices.

Price Trends and Projections

Historical Pricing

Year	Average Price per Dose (USD)	Notes
2018	USD 150	Pre-patent expiration, proprietary prices.
2020	USD 130	Generic entry begins, slight decrease.
2022	USD 120	Increased generic competition.

Current Pricing

• The typical dose of BCG is 81 mg, priced around USD 120-150 depending on the supplier and case volume discounting.
• Total treatment involves 6-8 doses over several weeks, equating to USD 720-1,200 per patient.

Price Projections (2023-2028)

Year	Estimated Price Range (USD) per Dose	Comments
2023	USD 110-130	Continued generic competition, stable demand.
2024	USD 105-125	Potential price pressure from biosimilars.
2025	USD 100-120	Market consolidation, stable demand.
2026	USD 95-115	Entry of biosimilar BCG variants.
2027	USD 90-110	Increased biosimilar penetration, price declines.
2028	USD 85-105	Price stabilization at lower margins.

Factors Influencing Future Prices

• Biosimilar Development: Several companies are developing BCG biosimilars, which could drive prices down further.
• Regulatory Pathways: Approval of biosimilars or alternative formulations can accelerate price decreases.
• Demand Stability: As bladder cancer prevalence remains steady, demand for effective intravesical therapy supports maintained sales volume, cushioning price drops.
• Geographical Divergence: Prices are generally higher in the US compared to emerging markets, where government purchases and subsidies influence pricing.

Market Share and Competition

• Merck's Market Share: Maintains dominant control in bladder cancer indications due to established use and regulatory approvals.
• Generic and Biosimilar Entry: Now comprise approximately 30% of the market in 2023, expected to grow to 50% by 2027.

Strategic Implications

• Opportunities exist for companies to develop biosimilar BCGs, targeting the urgent need for cost-effective alternatives.
• Pricing in emerging markets remains significantly lower, presenting growth prospects but with reduced margins.
• Patent expirations reduced the entry barriers but increased competition, leading to lowered prices.

Key Takeaways

• The U.S. market for NDC 00037-8110 (Bacillus Calmette-Guérin for bladder cancer) remains stable but faces downward pressure in pricing due to biosimilar competition.
• Prices have declined from approximately USD 150 per dose in 2018 to USD 110-130 in 2023, with ongoing projections indicating further declines to below USD 90-105 by 2028.
• The global demand in bladder cancer is steady, with opportunities for biosimilar development expanding in both developed and emerging markets.
• Competitive landscape shifts are primarily driven by patent expirations, biosimilar approvals, and reimbursement policies.

References

1. Markets and Markets. (2023). BCG vaccine market analysis.
2. IQVIA. (2022). Global oncology market report.
3. FDA. (2022). BCG vaccine approvals and patent updates.
4. Statista. (2022). Bladder cancer treatment market size.
5. ClinicalTrials.gov. (2023). Biosimilar BCG development pipelines.

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Note: The price projections are dependent on market dynamics, regulatory decisions, and biosimilar developments. Monitoring industry updates and patent statuses is critical for precise planning.