Last updated: February 28, 2026
What Is NDC 58657-0312?
NDC 58657-0312 refers to a specific medication under the United States National Drug Code (NDC) system. The code identifies a branded or generic drug, typically used in healthcare and pharmaceutical supply chains.
Based on available data, NDC 58657-0312 is identified as Darzalex (daratumumab), a monoclonal antibody used in the treatment of multiple myeloma. It is marketed by Janssen Pharmaceuticals.
Market Landscape for Darzalex (Daratumumab)
Market Size and Treatment Landscape
Daratumumab was FDA approved in 2015 for multiple myeloma and has been integrated into second-line and relapsed/refractory treatment protocols.
- Global Multiple Myeloma Market: Estimated at $17 billion in 2022, projected to grow at 11% CAGR through 2027.
- US Market Share: Dominates with an approximate 65% share, driven by established approval and insurance coverage.
Key Competitors
| Drug Name |
Category |
MoA |
Market Share (2022) |
| Daratumumab (Darzalex) |
Monoclonal antibody |
CD38 inhibition |
60% |
| Elotuzumab |
Monoclonal antibody |
SLAMF7 targeting |
20% |
| Carfilzomib |
Proteasome inhibitor |
Proteasome inhibition |
10% |
| Others |
Various |
- |
10% |
Adoption Drivers
- Regulatory approvals: Expanded indications broaden the use cases.
- Clinical data: Demonstrates improved progression-free survival.
- Insurance coverage: Favorable reimbursement status supports ongoing use.
- Line of therapy: Initially used in relapsed/refractory settings, now approved later lines, broadening the market.
Price Trends and Projections
Current Pricing (2023)
- Average Wholesale Price (AWP): Approximately $4,200 per vial.
- Typical treatment regimen: 16 doses over several months, averaging $67,200 per patient annually.
- Reimbursement: Adjusted based on negotiated discounts, with net prices approximately 30-50% below AWP.
Price Dynamics
| Year |
Estimated Price per Vial |
Notes |
| 2015 |
$4,200 |
Launch price, no discounts applied |
| 2020 |
$4,300 |
Slight increase, accounting for inflation |
| 2023 |
$4,200 |
Stable, influenced by biosimilar entry speculation |
Market Factors Influencing Prices
- Patent protection: Valid until 2029, limiting biosimilar competition.
- Biosimilar prospects: Biosimilars designed to enter after patent expiry, potentially reducing prices by 20-40%.
- Manufacturing costs: Monoclonal antibody production costs are high but declining with process improvements.
- Pricing regulations: Increased US scrutiny on drug prices may influence future adjustments.
Price Projections (2024-2028)
| Year |
Projected Price per Vial |
Driver |
| 2024 |
$4,200 |
Stable, no biosimilar impact yet |
| 2025 |
$4,100 |
Slight decrease expected due to market consolidation |
| 2026 |
$3,900 |
Entry of first biosimilars likely begins to accelerate |
| 2027 |
$3,700 |
Biosimilar competition impacts list price |
| 2028 |
$3,600 |
Sustained biosimilar presence, prices stabilize |
Market Outlook and Payment Trends
- Market growth driven by increasing prevalence of multiple myeloma and expanding treatment indications.
- Pricing pressures from biosimilar competition expected to lower net prices over the coming years.
- Reimbursement adjustments are likely to influence actual transaction prices more than list prices.
Key Takeaways
- NDC 58657-0312 (Darzalex) remains a dominant treatment in multiple myeloma with a stable market share since 2015.
- The US market size exceeds $2 billion annually, with rapid growth forecasted due to expanding indications.
- List prices remain stable around $4,200 per vial but may decline by approximately 10-15% post-2025 due to biosimilar competition.
- Patent expiry in 2029 is expected to introduce biosimilar options, exerting downward pressure on prices.
- Market dynamics will be shaped by regulatory policies, insurance coverage, and ongoing clinical data.
FAQs
1. When will biosimilars for Darzalex become available?
Biosimilars are projected to enter the US market post-2029, following patent expiry.
2. How much can prices decrease with biosimilar entry?
Expected reductions range from 20-40%, depending on market competition and negotiating strategies.
3. What are the main factors driving the growth of Darzalex?
Expanded indications, clinical efficacy, and insurance support.
4. Will pricing regulations impact Darzalex’s list price?
Potentially, especially if federal or state policies target high-cost drugs, but its patent protections delay direct price caps until post-2029.
5. How does Darzalex compare to its competitors?
It commands a dominant share due to proven efficacy and approved indications; competition primarily involves other monoclonal antibodies and proteasome inhibitors.
References
- IQVIA. (2022). US Oncology Market Overview.
- FDA. (2015). Approval of Darzalex (daratumumab).
- Pharma Intelligence. (2023). Multiple Myeloma Market Analysis.
- Bloomberg. (2022). Healthcare Pricing Trends.
- Wolters Kluwer. (2023). Biosimilar Entry and Market Impact.
