Last updated: March 9, 2026
What is NDC 60687-0716?
The National Drug Code (NDC) 60687-0716 is a specific medication identified in the FDA database. This NDC corresponds to Mitomycin for injection, marketed primarily for oncology indications. Mitomycin is an antineoplastic agent used in the treatment of various cancers, including stomach, pancreas, and bladder cancers.
Market Overview
Current Market Size
The global oncology drug market was valued at approximately $150 billion in 2022. Oncology injectables constitute about 40% of this, with mitomycin representing a subset of this segment.
Key Competitors
Mitomycin competes with other alkylating agents and anthracyclines. Major products include:
- Doxorubicin
- Cisplatin
- Cyclophosphamide
Mitomycin’s market share is constrained by availability of newer targeted therapies but remains relevant due to its established efficacy and cost profile.
Regulatory Status
- Approved by the FDA for specific indications, including localized intravesical therapy and adjunct in chemotherapy regimens.
- Marketed in the U.S. by multiple generic manufacturers since patent expiration in the early 2000s.
Supply Chain Factors
Manufacturing is complex, requiring stringent sterile processing. Suppliers include several generic drug companies with established production capabilities.
Price Trends
Historical Pricing Data
- Average wholesale price (AWP) for mitomycin injection (10 mg vial): ranged from $90 to $140 over the past five years.
- Reimbursement rates have remained relatively stable due to its generic status, often around 70-90% of AWP in commercial settings.
Market Influences on Pricing
- Generic Competition: More manufacturers entering the market have driven prices down by approximately 15% over five years.
- Supply Chain Disruptions: Minor shortages have historically temporarily increased prices by 10-20%.
- Regulatory Changes: No recent FDA regulation directives have directly impacted price.
Price Projections (Next 5 Years)
| Year |
Estimated AWP Range per 10 mg Vial |
Notes |
| 2023 |
$90 - $140 |
Current price range |
| 2024 |
$85 - $130 |
Slight price decrease expected due to increased competition |
| 2025 |
$80 - $125 |
Continued market saturation may pressure prices |
| 2026 |
$75 - $120 |
Potential new biosimilar entry or market stabilization |
| 2027 |
$70 - $115 |
Prices may stabilize or slightly decline further |
Assumptions include stable regulatory environment and no significant supply disruptions.
Future Market Drivers
- Emergence of targeted therapies may diminish mitomycin’s market share in some cancer types.
- Cost pressures from healthcare systems favor lower-priced generics.
- New formulations (e.g., combination products) could alter pricing dynamics.
- Biosimilar development remains unlikely, as mitomycin is a small-molecule drug.
Key Market Opportunities and Risks
Opportunities
- Expansion into new regional markets with limited access to advanced therapies.
- Development of combination regimens that improve patient outcomes.
- Competitive pricing strategies to maintain market share.
Risks
- Patent expirations affecting market exclusivity, though mitomycin’s patent status is well established.
- Entry of newer therapies with better safety profiles.
- Policy changes impacting drug reimbursement.
Conclusions
Mitomycin (NDC 60687-0716) remains a relevant option in oncology treatment, with prices expected to decline gradually over the next five years, driven by increased competition and market saturation. Its overall market size is limited relative to novel targeted agents but maintains stable demand within specific treatment protocols.
Key Takeaways
- The current AWP per 10 mg vial ranges from $90 to $140.
- Price projections suggest a decline to approximately $70-$115 by 2027.
- Market share is influenced by biosimilar entry, competition, and healthcare policy.
- Mitomycin remains integral in chemotherapy regimens but faces competition from newer agents.
- Supply stability and regulatory environment are crucial for pricing stability.
FAQs
Q1: What are the main indications for mitomycin (NDC 60687-0716)?
A1: It is primarily used in chemotherapy for stomach, pancreatic, bladder, and other cancers.
Q2: How does market competition affect pricing?
A2: Increased generic competition drives prices downward due to market saturation.
Q3: What regulatory changes could impact price trends?
A3: New reimbursement policies, drug pricing reforms, or biosimilar approvals could influence prices.
Q4: Are biosimilars or generics available for mitomycin?
A4: Multiple generics are available; biosimilars are unlikely due to its small-molecule status.
Q5: What regional factors could influence market dynamics?
A5: Healthcare policies, approval status, and reimbursement rates vary by country, affecting availability and pricing.
References
- U.S. Food & Drug Administration. (2023). FDA drug database. https://www.fda.gov/drugs
- IQVIA. (2022). Oncology Market Reports.
- Red Book. (2023). Pharmaceutical pricing and distribution data.
- Statista. (2022). Global oncology drug market data.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement and coverage policies.
