Last updated: February 14, 2026
What Is the Market for NDC 67457-0265?
NDC 67457-0265 corresponds to Libilv (lenalidomide) capsules, a drug primarily used for treatment of multiple myeloma and certain myelodysplastic syndromes. Its market includes oncology clinics, hematology centers, and specialty pharmacies, with geographic focus on the United States.
Current Market Size and Demand
- The global multiple myeloma drugs market was valued at approximately USD 9 billion in 2022, expected to grow at a CAGR of 8.5% through 2030 [1].
- Lenalidomide accounts for a significant share within this segment, owing to its approval for multiple indications including multiple myeloma, mantle cell lymphoma, and anemia associated with myelodysplastic syndromes.
- In the U.S., approximately 35,000 new multiple myeloma cases are diagnosed annually [2], with nearly all patients receiving lenalidomide as part of their treatment regimen.
- The drug is also heavily utilized in established patient populations, supporting a sustained revenue base.
Price Landscape for Lenalidomide Capsules
Current Wholesale and Retail Pricing
| Price Metric |
Approximate Range (USD) |
Notes |
| Wholesale Acquisition Cost (WAC) |
$3.50 - $4.00 per capsule |
Varies by supplier, generally aligned with manufacturer pricing |
| Average Wholesale Price (AWP) |
$4.20 - $4.80 per capsule |
Reflects average pharmacy procurement costs |
| Patient out-of-pocket (25% coinsurance) |
$1.00 - $1.20 per capsule |
Assuming standard insurance copay structure |
Pricing Dynamics
- Competition from biosimilars and generics influences the retail price but lenalidomide remains under patent protection until 2026 in the U.S.
- Price negotiations with payers, specialty pharmacy discounts, and rebate programs significantly affect net revenue.
- Extended or new indications could lead to pricing adjustments.
Patent and Regulatory Environment
- Lenalidomide was originally launched by Celgene (acquired by Bristol-Myers Squibb in 2019).
- Patent protection for key formulations extends until 2026, delaying generic entry.
- FDA approval modifications for additional indications may influence pricing and market share.
Price Projections
Short-term (2023-2025)
- Prices are expected to remain stable with slight downward pressure from biosimilar entries anticipated in 2026.
- Given current patent protection, retail prices forecasted to stay within $4.00 - $5.00 per capsule range.
- Payer negotiations and rebate structures will moderate net revenue growth.
Medium-term (2026-2030)
- Entry of biosimilars and generics could reduce prices by 20-40%, depending on market response.
- Maximum retail price could decline to $2.50 - $3.00 per capsule.
- Market expansion into additional indications could sustain volume growth, offsetting price reduction.
Key Factors Impacting Prices
- Patent expirations.
- Regulatory approvals for new indications.
- Entry of biosimilars and generic competitors.
- Insurance reimbursement policies and negotiated discounts.
- Supply chain dynamics, including manufacturing costs.
Competitive Landscape and Market Share
- Major competitors include other myeloma treatments such as carfilzomib, daratumumab, and pomalidomide.
- Lenalidomide holds a dominant market share in its niche, with approximately 70% of first-line multiple myeloma prescriptions [3].
- Biosimilar entrants post-2026 may erode this share, impacting pricing strategies.
Summary
| Aspect |
Status/Projection |
| Current Price Range |
$3.50 - $4.80 per capsule |
| Patent Expiry |
2026 in the U.S. |
| Post-patent generic entry |
Expected reduction in price by 2026-2030 (~20-40%) |
| Market Size (2022) |
USD 9 billion globally |
| Growth Rate |
8.5% CAGR through 2030 |
Key Takeaways
- The market size for lenalidomide remains substantial due to its central role in multiple myeloma treatment.
- Prices are stable until patent expiration in 2026, with potential reductions aligned with generic/biosimilar entry.
- The drug's strong position in established treatment regimens ensures consistent demand.
- Reimbursement factors considerably influence net market pricing.
- Strategic initiatives ahead include preparing for post-patent price competition and exploring new indications.
FAQs
1. When will generic versions of lenalidomide be available in the U.S.?
Patent protections expire in 2026, after which generic and biosimilar versions are expected to launch.
2. How will biosimilar competition affect price projections?
Prices are likely to decline by approximately 20-40%, depending on market penetration and payer negotiations.
3. What are the main factors influencing lenalidomide pricing today?
Regulatory status, patent protections, payer negotiations, and competition shape current prices.
4. Are there ongoing clinical trials that could extend lenalidomide’s indications?
Yes, multiple trials are investigating additional uses, which could impact future pricing and market size.
5. How does the growth in multiple myeloma diagnoses influence market demand?
An increasing incidence supports sustained or expanding demand for lenalidomide, bolstering its revenue potential even as prices decline.
References
[1] MarketsandMarkets. (2022). "Multiple Myeloma Drugs Market."
[2] American Cancer Society. (2022). "Key Statistics for Multiple Myeloma."
[3] IQVIA. (2022). "Pharmaceutical Market Data."
