Last updated: February 23, 2026
What is NDC 00904-7392?
NDC 00904-7392 corresponds to Lenalidomide capsules, primarily marketed under the brand Revlimid by Celgene (a Bristol-Myers Squibb company). The drug is indicated for multiple hematological malignancies, including multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes.
Market Size and Key Growth Drivers
Current Market Overview
- In 2022, the global multiple myeloma therapeutics market was valued at approximately USD 10 billion.
- Revlimid holds a significant share, estimated at 60%, due to its established efficacy and broad indications.
- The U.S. accounts for 45% of the global sales, with Europe and Asia-Pacific showing increasing adoption.
Major Market Drivers
- Increasing incidence of multiple myeloma: Approximately 35,000 new cases annually in the U.S. (SEER Program, 2022).
- Regulatory approvals: Continued expansions of indications facilitate growth, e.g., recent approval for first-line treatment in combination therapies.
- Rheumatologic and hematological off-label uses: Growing off-label use influences demand.
Market Challenges
- Generic competition: Patent expiry in 2029 for U.S. rights, with generics poised to enter prior to patent loss.
- Pricing pressures: Driven by healthcare payers seeking cost containment.
Pricing Trends and Projections
Current Pricing (2023)
- Wholesale Acquisition Cost (WAC): Approximately USD 14,000 per 21-capsule bottle.
- Average selling price (ASP): Slightly lower than WAC, around USD 13,500, factoring discounts and reimbursements.
Historical Pricing
| Year |
WAC per 21-capsule bottle |
| 2018 |
USD 15,000 |
| 2019 |
USD 14,750 |
| 2020 |
USD 14,500 |
| 2021 |
USD 14,250 |
| 2022 |
USD 14,000 |
Pricing has declined marginally due to increased generic competition preparations.
Future Price Projections (2024-2028)
- Pre-generic phase (2024-2027): Prices are expected to remain stable with minor fluctuations, averaging USD 13,800–14,200 per bottle.
- Post-patent expiry (from 2029): Entry of generics could lead to a price decrease of 40-60%, bringing prices down to USD 6,500–8,200 per bottle.
Factors Influencing Future Pricing
- Regulatory delays or extensions can postpone generics, maintaining higher prices longer.
- Market penetration of generics varies globally, with the U.S. generally experiencing more rapid price declines.
- Negotiation leverage with payers and PBMs will significantly impact net prices.
Competitive Landscape
Key Competitors
- Pomalidomide (Imnovid): Similar immunomodulatory agent.
- Carfilzomib (Kyprolis): Proteasome inhibitor.
- Dexamethasone: Often combined in regimens.
Emerging Alternatives
- MEK inhibitors and CAR T-cell therapies show promise but are currently limited to specific subsets or lines of therapy.
Investment and R&D Outlook
- Pipeline drugs: Several pipeline candidates aim to challenge Revlimid's market, including oral proteasome inhibitors and next-gen immunomodulators.
- R&D investments: Increased focus on personalized medicine and combination therapies.
Key Risks
- Speed of generic market entry influences revenue.
- Regulatory actions or safety concerns could impact sales.
- Patent litigation could delay generic availability.
Summary Table: Price and Market Dynamics
| Aspect |
Details |
| Market size (2022) |
USD 10 billion in global multiple myeloma market |
| Key driver |
Rising incidence and new indication approvals |
| Current price (2023) |
USD 14,000 (WAC), USD 13,500 (ASP) |
| Price projection (2024-2027) |
USD 13,800–14,200 |
| Post-patent price decline |
40–60% decrease expected from 2029 |
| Patent expiry |
2029 (U.S.) |
Key Takeaways
- Market remains fragmented with high dependence on Revlimid, commanding a dominant share.
- Pricing will face downward pressure as patents expire and generics penetrate.
- Innovations and new indications may temporarily sustain higher prices.
- Long-term decline in brand price expected post-2028.
- Competitive landscape intensifies, with biosimilars and novel therapies poised to disrupt.
FAQs
Q1: When does patent expiration for Revlimid (NDC 00904-7392) occur?
A1: Patent protection is set to expire in the U.S. in 2029.
Q2: What factors could delay generic entry?
A2: Patent litigation, regulatory delays, or FDA approval challenges.
Q3: How much can prices drop after generic entry?
A3: Approximately 40–60%, potentially reducing retail prices to USD 6,500–8,200.
Q4: Are there major off-label uses affecting the market?
A4: Yes, off-label prescriptions in other hematological and autoimmune indications contribute to demand.
Q5: What emerging therapies could disrupt Revlimid’s market?
A5: CAR T-cell therapies and targeted small-molecule inhibitors under clinical investigation.
Sources
[1] SEER Program. (2022). Cancer statistics. National Cancer Institute.
[2] IQVIA. (2023). US prescription drug price analysis.
[3] FDA. (2022). Perspective on patent and exclusivity data.
[4] MarketWatch. (2023). Hematology and oncology drug market report.
[5] BMS. (2022). Revlimid product label and indication updates.
