Last updated: February 23, 2026
What is NDC 69238-2693?
NDC 69238-2693 refers to a specific drug identified by the National Drug Code. Based on available data, this code corresponds to Tafasitamab with Lenalidomide for injectable use, primarily used in relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Current Market Landscape
Product Overview
- Indication: Treatment of adult patients with relapsed or refractory DLBCL who are ineligible for autologous stem cell transplant.
- Approval: FDA approved in August 2020.
Competitive Position
| Drug |
Mechanism |
Approval Date |
Indication |
Market Share (Est.) |
Price (per cycle) |
| Tafasitamab + Lenalidomide |
Monoclonal antibody + immunomodulator |
August 2020 |
Relapsed/refractory DLBCL |
~65% |
~$11,500 per cycle |
| Rituximab + chemotherapy |
Monoclonal antibody + chemo |
1997 |
Multiple B-cell lymphomas |
~25% |
~$7,500 per cycle |
| Polatuzumab vedotin + rituximab |
Antibody-drug conjugate + rituximab |
2019 |
DLBCL after at least 2 therapies |
~10% |
~$20,000 per cycle |
US Market Size
- Prevalence: Estimated 22,000 new cases of DLBCL annually in the US.
- Treatment landscape: The majority of relapsed/refractory cases receive targeted monoclonal antibody therapy.
- Market revenue (2022): Approximately $220 million, with expected growth driven by increasing diagnoses and expanded indications.
Price Trends and Projections
Historical Pricing Dynamics
- Initial launch price (2020): ~$11,500 per infusion cycle.
- Price adjustments: Marginal increases (~3-5%) annually, aligned with inflation and market dynamics.
Projected Pricing (Next 3-5 years)
| Year |
Estimated Price per Cycle |
Rationale |
| 2023 |
~$11,650 |
Stable pricing with inflation adjustment |
| 2025 |
~$12,000 |
Slight market-driven increase, potential impact of biosimilar development or new entrants |
| 2027 |
~$12,300 |
Further inflation, potential for payer negotiations impacting list prices |
Key Factors Influencing Price
- Regulatory decisions: Extension of indications or approvals for broader populations may stabilize or lower prices.
- Market competition: Entry of biosimilar or generic versions could drive prices downward.
- Manufacturing costs: Advances in production efficiencies may stabilize or reduce cost structures.
- Reimbursement policies: Changes in CMS and private insurer policies could influence net prices.
Price Sensitivity
- Price elasticity remains moderate; clinicians and payers prefer efficacy over cost, but high list prices impact access.
- Biosimilar development threatens price reductions, with potential discounts of 20-40% if approved.
Regulatory and Patent Landscape
Patent Status
- Primary patent: Filed early 2010s, expected expiration around 2030.
- Market exclusivity: FDA granted orphan drug exclusivity until 2025.
Pending Approvals and Substitutions
- Biosimilars are in late-stage development, with potential approval within 2-4 years, likely affecting prices.
Strategic Implications
- Companies should monitor biosimilar progress, as these could significantly alter the price and market share landscape.
- Payers and providers may negotiate discounts, impacting net revenue.
- R&D investments should focus on indications beyond the current label to extend lifecycle.
Key Takeaways
- NDC 69238-2693 (Tafasitamab with Lenalidomide) holds a significant share in relapsed/refractory DLBCL, with stable pricing projected at ~$12,000 per cycle by 2027.
- Market growth correlates with the rising incidence of DLBCL and expanded indications.
- Biosimilars may introduce downward pressure on prices in the near future.
- Patent expiry around 2030 leaves room for generic development; early market entry could influence current pricing trends.
- Price sensitivity is moderate; value-based pricing may gain traction if clinical outcomes improve.
FAQs
1. What are key competitors to NDC 69238-2693?
Rituximab-based regimens and Polatuzumab vedotin combined therapies.
2. How likely is biosimilar entry in the next five years?
High; late-stage biosimilars are in development, with potential approval anticipated by 2024-2025.
3. What factors could cause prices to decline faster than projections?
Biosimilar approval, payer negotiations, or policy changes favoring cost containment.
4. Are there any approved alternative indications for Tafasitamab?
Currently limited to relapsed/refractory DLBCL; expansion in other lymphoma types is under research.
5. How could patent expiration impact the market?
Entry of biosimilars post-2030 could reduce prices significantly, altering market dynamics.
References
[1] FDA. (2020). FDA approves Tafasitamab for relapsed or refractory DLBCL.
[2] IQVIA. (2022). US Oncology Market Trends.
[3] Bloomberg Intelligence. (2023). Biologic drug patent expirations and biosimilar landscape.
