Last updated: March 13, 2026
What is NDC 00781-8036?
NDC 00781-8036 corresponds to Revlimid (lenalidomide) 15 mg capsules, manufactured by Celgene (a Bristol-Myers Squibb company). Approved for multiple hematologic malignancies, including multiple myeloma, myelodysplastic syndromes (MDS), and mantle cell lymphoma.
Market Overview
Therapeutic Indications
- Multiple myeloma (MM)
- Myelodysplastic syndromes (MDS)
- Mantle cell lymphoma (MCL)
Key Market Players
- Celgene (Bristol-Myers Squibb)
- Multiple biosimilars and generics manufacturing firms aiming to enter the market.
- Competing drugs include Pomalyst (pomalidomide), Thalomid (thalidomide), and proteasome inhibitors like Velcade (bortezomib).
Market Size
- 2022 global sales surpassed $4 billion for lenalidomide products.
- The U.S. accounts for approximately 60% of sales, driven by high prevalence of multiple myeloma and MDS.
- The MM segment dominates, with over 50% of total sales revenue.
Regulatory and Patent Environment
- Original patent expired in the U.S. in 2026 (with various patent disputes ongoing).
- Biosimilar entrants forecasted to gain market share from 2026 onward.
- Price controls and reimbursement policies vary by country, impacting net market sales.
Supply Chain Considerations
- Manufacturing capacity increases have been reported, with efforts to reduce export restrictions.
- Demand from specialty pharmacies and hospital systems continues to grow.
Price Projections
Current Pricing Model
- Wholesale Acquisition Cost (WAC): approximately $800 per 28-count capsule (15 mg).
- List Price (2023): roughly $28,800 per year per patient, assuming daily dosing.
- Actual transaction prices are lower due to discounts, rebates, and insurance negotiations.
Short-term (2023–2025)
- Prices are projected to remain stable amid patent protection and high demand.
- Reimbursement and coverage policies influence actual prices paid by payers.
- Price erosion expected to be limited due to ongoing patent protections until 2026.
Post-Patent (2026 onwards)
- Biosimilar competition expected to reduce lenalidomide prices significantly.
- Biosimilar prices could undercut original branded versions by 20-40%, with some estimates indicating a drop to approximately $16,000–$20,000 annually per patient.
- Price reductions for capsules may occur more rapidly in European markets, following regulatory approvals.
Market Penetration of Biosimilars
- Forecasted to capture up to 50% of the U.S. market within 3–5 years of biosimilar entry.
- Price competition likely to drive overall market prices lower by 2027–2028.
Revenue Impact
| Year |
Estimated Market Price |
Estimated Market Share (Brand vs. Biosimilar) |
Projected Revenue (U.S.) |
| 2023 |
$28,800/year |
100% (branded) |
~$2.9B |
| 2025 |
$28,800/year |
80% (brand), 20% (biosimilar) |
~$2.3B |
| 2027 |
$20,000/year |
40% (biosimilar), 60% (brand) |
~$1.7B |
Key Factors Influencing Market and Pricing
- Patent expiration and biosimilar approval timelines.
- Reimbursement policies, especially in Medicaid, Medicare, and private insurance.
- The emergence of combination therapies impacting demand.
- Supply chain capacity and manufacturing costs.
- Regulatory approvals in international markets.
Summary of Risks and Opportunities
- Risks: Patent litigation delays biosimilar entry; pricing power in some markets limited by regulations.
- Opportunities: Expanding indications, international market expansion, biosimilar competition enhancing volume sales.
Key Takeaways
- The current market for Revlimid is highly lucrative, with global sales exceeding $4 billion.
- Price stability is expected until patent expiry in 2026.
- Post-2026, biosimilar competition will substantially lower prices, impacting revenues.
- Market share shifts depend on biosimilar regulatory approvals, competitive dynamics, and reimbursement policies.
- Supply chain and manufacturing capacity enhancements could influence pricing and availability.
FAQs
How long is Revlimid patent protected in the U.S.?
Patent protection lasts until 2026, after which biosimilars are expected to enter the market.
What will be the price of lenalidomide after biosimilar competition?
Estimated to decrease by 20-40%, with projected prices around $16,000–$20,000 annually per patient.
What are the main drivers of Revlimid sales?
High prevalence of multiple myeloma and MDS, approved indications, and treatment protocols in oncology.
How might biosimilar entry impact the market?
Biosimilar entry will increase competition, reduce prices, and potentially expand access globally.
What regulatory challenges could delay biosimilar adoption?
Patent disputes and approval processes in regions like the U.S., Europe, and other international markets.
References
- FDA (2022). Revlimid (lenalidomide) prescribing information. Retrieved from https://www.fda.gov
- IQVIA (2023). Pharmaceutical market data.
- EvaluatePharma (2022). World Forecast Total Market Value.
- U.S. Patent and Trademark Office. (2022). Patent status for lenalidomide.
- World Health Organization (2021). Global cancer statistics.
