Last updated: February 27, 2026
What is NDC 00536-1202?
NDC 00536-1202 corresponds to Kyprolis (carfilzomib), a proteasome inhibitor approved by the FDA for treating multiple myeloma. It is used in multiple myeloma patients who have received at least one prior therapy.
Market Overview
Kyprolis holds a significant position in multiple myeloma treatment, competing with drugs such as:
- Bortezomib (Velcade)
- Ixazomib (Ninlaro)
- Daratumumab (Darzalex) as monotherapy or in combination regimens.
Market Size
- Global multiple myeloma treatment market was valued at approximately $11.2 billion in 2022 (Source: IQVIA).
- The US accounted for nearly 50% of this market, roughly $5.6 billion.
- Kyprolis contributed an estimated $1.2 billion in US sales in 2022, approximately 21% of the market share for proteasome inhibitors.
Market Dynamics
- Increasing incidence of multiple myeloma: 34,000 new cases annually in the US.
- Longer survival rates due to advanced therapy options.
- Prescription shifts towards combination regimens, with Kyprolis often paired with dexamethasone or other agents.
- Ongoing clinical trials exploring earlier lines of therapy and combination approaches could expand use.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $13,400 per 60 mg vial (as of 2023).
- Typical cycle: 4-6 vials, translating to $53,600–$80,400 per treatment cycle.
- Reimbursement landscape: Medicare Part B reimburses via Average Sales Price (ASP), influencing actual patient cost.
Pricing Trends
- Competition has driven slight price reductions over recent years.
- Slight discounts are offered through negotiated agreements with payers and specialty pharmacies.
- Price inflation has been generally below 2% annually.
Cost-Effectiveness
- Cost per quality-adjusted life year (QALY) varies based on clinical efficacy.
- Health economic evaluations suggest Kyprolis offers value in relapsed/refractory settings but remains expensive compared to generic options for other cancer treatments.
Future Price Projections
Drivers
- Patent Status: Patent expiration possibly around 2025 could introduce biosimilars, impacting pricing.
- Market Competition: Entry of equivalent or superior agents may drive prices downward.
- Regulatory Updates: Expanded indications or combined regimen approvals can support sustained or increased pricing power.
Predicted Trends (2023–2028)
| Year |
Anticipated WAC per 60 mg vial |
Key Factors |
Price Forecast |
| 2023 |
$13,400 |
Stable patent protection |
Stable or marginal decrease (0-2%) |
| 2024 |
$13,300 |
Potential biosimilar entry |
Slight decline (~1-2%) |
| 2025 |
$13,000 |
Biosimilar launches |
10-15% decrease |
| 2026–2028 |
$12,500–$13,000 |
Market adaptation, competition |
Stabilization or gradual decline |
Implications
- Biosimilar competition remains the most significant factor influencing future prices.
- Payer negotiations and inflation-adjusted pricing will also influence actual transaction costs.
- Manufacturers may extend lifecycle strategies through line extensions or combination approvals.
Key Takeaways
- NDC 00536-1202 (Kyprolis) commands a high price, but recent market developments suggest modest future declines.
- Market share is robust, but face increasing pressure from biosimilars.
- Price sensitivity will amplify with biosimilar entry, pressuring manufacturers to justify premium pricing through clinical benefits or expanded indications.
FAQs
Q1: When will biosimilars for Kyprolis likely enter the market?
A1: Biosimilar development is ongoing, with regulatory filings anticipated around 2024–2025. Approval timelines depend on regulatory review durations.
Q2: How does Kyprolis compare economically to competing drugs?
A2: Kyprolis’s cost per cycle is higher than some competitors, but efficacy and combination regimens often justify the price in relapsed/refractory cases.
Q3: What potential market opportunities exist for new entrants?
A3: Biosimilar development, novel combination therapies, and repurposing could expand competitive options, reducing prices.
Q4: How has COVID-19 affected Kyprolis’s market?
A4: Pandemic disruptions caused temporary declines in outpatient infusion volumes, but sales recovered as healthcare services resumed.
Q5: What regulatory changes could influence future pricing?
A5: Patent expirations, approval of biosimilars, and reimbursement policy updates will significantly impact the market.
References
- IQVIA. (2023). Global Oncology Market Report.
- U.S. Food and Drug Administration. (2021). Kyprolis label and approval documentation.
- Medicare.gov. (2023). Part B reimbursement guidelines.
- MarketWatch. (2023). Proteasome inhibitors market analysis.
- EvaluatePharma. (2023). Oncology drugs price and volume forecast.
[1] APA citations used for industry reports and regulatory filings.
