Last updated: March 3, 2026
What Is NDC 64764-0046?
NDC 64764-0046 corresponds to Zynlonta (loncastuximab tesirine-lpyl), a monoclonal antibody drug conjugate approved for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (FDA, 2021). The drug is manufactured by ADC Therapeutics and belongs to the class of antibody-drug conjugates targeting CD19-positive malignancies.
Market Overview
Therapeutic Area Demand
- Target Population: DLBCL is the most common type of non-Hodgkin lymphoma, affecting approximately 26,000 adults annually in the U.S. (NCI, 2020).
- Recurrent/Refractory Cases: Around 30% of DLBCL patients relapse or are refractory to initial therapy, representing up to 7,800 potential annual treatment candidates in the U.S.
- Market Penetration: Currently, standard therapies include chemo-immunotherapy. Zynlonta offers an option for patients ineligible for stem cell transplantation or those who failed prior treatments.
Competitive Landscape
| Product |
Indication |
Approval Year |
Market Share (2022) |
Price per dose (USD) |
| Polivy (polatuzumab) |
DLBCL, relapsed/refractory |
2019 |
20% |
8,000 |
| Rituxan (rituximab) |
Non-Hodgkin lymphoma |
1997 |
30% |
6,000 |
| Trodelvy (sacituzumab) |
Breast, triple-negative |
2020 |
10% |
12,000 |
Zynlonta’s entry expands options, especially for patients who have exhausted standard therapies.
Market Entry Timing
- Approval Date: April 2021 (FDA).
- Market Launch: The drug’s commercialization began in late 2021, with initial national coverage.
- Reimbursement: Secured through Medicare, Medicaid, and private payers.
Pricing Strategy and Projections
Current Pricing
- List Price: $37,100 per 20-mL vial (FDA label, 2021).
- Dosing Regimen: 150 mg IV infusion every 3 weeks for up to 2 years.
- Average Treatment Course: Approximately 6 doses, leading to an approximate treatment cost of $222,600 per patient.
Cost-Effectiveness Considerations
- Cost per quality-adjusted life year (QALY) remains competitive relative to other therapies for relapsed DLBCL, which range from $50,000 to $150,000 (NICE, 2020).
Price Trajectory (2023–2028)
| Year |
Estimated Price per Dose (USD) |
Rationale |
| 2023 |
37,100 |
List price maintained with inflation (~3%) |
| 2024 |
38,300 |
Slight increase reflecting inflation and market competition |
| 2025 |
38,900 |
Market penetration stabilizes, pricing adjustments for increased competition |
| 2026 |
39,500 |
Introduction of biosimilar or alternative therapies could pressure prices |
| 2027 |
40,000 |
Cost containment measures influence pricing; negotiations with payers intensify |
Discounting and Reimbursement Impact
- Net prices after discounts, rebates, and negotiated prices are estimated to be around 50-70% of list price.
- Insurance coverage may limit patient out-of-pocket costs, affecting revenue projections.
Revenue Estimates
Assuming a conservative market share of 15% among eligible relapsed/refractory DLBCL patients in the U.S., revenues could be projected as follows:
- 2023: $200 M, based on 1,200 patients treated annually.
- 2025: $350 M, as adoption increases.
- 2028: $450 M, assuming steady market growth and improved access.
International markets (EU, Asia) are expected to contribute an additional 30–40% of U.S. revenues, with local pricing variations.
Regulatory and Policy Factors
- Pricing Pressure: Healthcare systems push for cost reductions, with risk-sharing agreements and price negotiations scaling globally.
- Off-label Use and Expand Indications: Potential expansion could drive additional revenues, contingent on successful clinical trials and regulatory approval.
- Patent Life: Patent protection extends until 2032, supporting exclusivity and pricing power.
Key Takeaways
- Zynlonta holds a niche in relapsed/refractory DLBCL, with a high price point supported by its targeted mechanism and clinical efficacy.
- Market uptake is fueled by limited alternatives for refractory patients, with existing competitors holding about 30–35% of the market share.
- Price growth will face pressure due to biosimilar entry, payer negotiations, and value-based pricing trends.
- Revenue projections for 2023–2028 range from approximately $200 million to $450 million annually in the U.S., with additional revenues from international markets.
- Manufacturer strategies should focus on expanding indications, optimizing payer negotiations, and managing discounting to maximize profitability.
FAQs
1. How does Zynlonta compare in efficacy and safety to other DLBCL therapies?
Clinical trials show Zynlonta provides overall response rates around 48%, with manageable safety profiles. Comparative efficacy varies, with some competing agents offering similar response rates but differing in adverse events.
2. What are the primary cost drivers for Zynlonta treatment?
Drug acquisition costs, infusion services, and management of adverse events constitute main cost drivers. The treatment course's high list price significantly influences overall expenses.
3. Can market access and reimbursement impact future pricing?
Yes. Payer negotiations, formulary placements, and value assessments directly impact net prices and uptake.
4. What is the potential for off-label use?
Limited data exist for off-label use outside approved indications. Expansion into other B-cell malignancies is under clinical investigation.
5. How might biosimilar entries influence the market?
Entry of biosimilars or alternative conjugates could lead to price erosion, affecting revenue and reimbursement rates.
References
[1] Food and Drug Administration (FDA). (2021). Zynlonta (loncastuximab tesirine-lpyl): Approval letter. Retrieved from https://www.fda.gov
[2] National Cancer Institute (NCI). (2020). Non-Hodgkin lymphoma. Retrieved from https://www.cancer.gov
[3] National Institute for Health and Care Excellence (NICE). (2020). Cost-effectiveness analysis of DLBCL treatments. Retrieved from https://www.nice.org.uk
