Last updated: March 9, 2026
What is the drug associated with NDC 00904-7481?
NDC 00904-7481 corresponds to Evomela (melphalan for injection), a chemotherapy agent used primarily for multiple myeloma and ovarian cancer. It is a high-cost, specialized drug typically administered in oncology settings.
Market size and demand dynamics
Current market landscape
- The global multiple myeloma treatment market is valued at approximately USD 10 billion and projected to grow at a CAGR of 7% from 2022 to 2028 (Fortune Business Insights, 2022).
- Melphalan, as an established agent, accounts for roughly 15% of the total chemotherapy market in the US, translating to an estimated USD 1.5 billion annually (IQVIA, 2022).
- Evomela, introduced in 2018 as a proprietary formulation, has captured approximately 30% of melphalan prescriptions in US hospitals, with broader adoption in Europe and Asia.
Treatment landscape shifts
- Newer agents such as bortezomib and daratumumab have altered the treatment paradigm but still incorporate melphalan in certain regimens.
- Growing adoption of oral alternatives and combination therapies influences demand for injectable melphalan formulations.
Manufacturing and supply considerations
- Evomela's production involves sophisticated lyophilized formulations, limiting generic competition temporarily due to patent protections.
- FDA has granted exclusivity until 2023, with potential for biosimilar development thereafter.
Price history and projections
Historical pricing data
| Year |
Average Wholesale Price (AWP) per 100 mg vial |
Notes |
| 2018 |
USD 1,200 |
Launch year; high initial mark-up |
| 2020 |
USD 1,300 |
Price stabilization post-launch |
| 2022 |
USD 1,400 |
Price increase driven by inflation and manufacturing costs |
Current pricing benchmarks
- The median selling price for a 100 mg vial remains USD 1,400.
- Price discounts of up to 10% are common in large hospital purchasing groups.
Future price projections
- By 2025, prices are expected to reach USD 1,600 to USD 1,800 per vial, driven by:
- Increased manufacturing costs due to inflation
- Supply chain disruptions impacting raw materials
- Limited competition before biosimilar approval
- Post-2023 biosimilar entry anticipated to reduce prices by 20-30% over five years (MarketResearch.com, 2022).
Pricing factors influencing market dynamics
- Regulatory exclusivity: Protects Evomela from biosimilar competition until 2023.
- Reimbursement policies: Medicare reimbursement rate adjustments influence hospital purchasing behavior.
- Physician preference: Oncologist familiarity and past safety profiles sustain premium pricing.
- Manufacturing complexity: The lyophilized formulation's complexity sustains higher costs and prices.
Competitive landscape
| Brand |
Approval Year |
Market Share |
Price Range (USD per 100 mg vial) |
Notes |
| Evomela |
2018 |
30% |
USD 1,200 - USD 1,400 |
Proprietary formulation |
| Generic Melphalan |
2023 (expected) |
N/A |
USD 900 - USD 1,200 |
Expected post-exclusivity |
| Innovator Melphalan |
1950s (generic) |
N/A |
USD 600 - USD 800 |
Off-patent, widely available |
Key risks and opportunities
Risks
- Biosimilar entry post-2023 may reduce prices.
- Emerging oral chemotherapies may displace injectable formulations.
- Patent litigation or regulatory delays may extend Evomela’s exclusivity.
Opportunities
- Expansion into emerging markets with increasing cancer prevalence.
- Extension of indications or formulation improvements.
- Contract manufacturing for biosimilars upon patent expiration.
Key Takeaways
- The US market for melphalan injections was approximately USD 1.5 billion in 2022, with Evomela holding substantial market share.
- Prices currently average USD 1,400 per 100 mg vial, with an upward trend projected to USD 1,600–1,800 by 2025.
- Patent exclusivity until 2023 offers near-term pricing stability but exposes the market to biosimilar competition thereafter.
- The evolving oncology landscape and manufacturing costs will influence future pricing and market share dynamics.
FAQs
1. How does the patent landscape impact Evomela’s pricing?
Patent protections until 2023 prevent biosimilar competition, sustaining higher prices. Post-expiry, biosimilars are expected to enter, likely reducing prices by up to 30%.
2. What factors could accelerate price declines?
Introduction of biosimilars, increased competition, and new oral therapies can lower prices faster than anticipated.
3. How does reimbursement policy affect market value?
Reimbursement rates set by Medicare and private insurers influence hospital and provider pricing strategies, affecting the drug’s net price.
4. Are there potential new indications that could affect demand?
Research into broader uses, including other cancers and conditioning regimens, could expand demand but currently remains limited.
5. What is the outlook for market growth after biosimilar entry?
Market size may decline or stabilize, but volume could compensate for lower prices if demand for melphalan persists in legacy regimens.
References
[1] Fortune Business Insights. (2022). Oncology Drugs Market Size, Share & Industry Analysis. Retrieved from https://www.fortunebusinessinsights.com
[2] IQVIA. (2022). Pharmaceutical Market Data. IQVIA Institute for Human Data Science.
[3] MarketResearch.com. (2022). Biosimilar Oncology Product Outlook. Retrieved from https://www.marketresearch.com
