Last updated: February 14, 2026
What is NDC 52652-4001?
NDC 52652-4001 refers to Venclexta (venetoclax), a BCL-2 inhibitor approved by the FDA for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML). It is marketed by AbbVie and Roche through a collaboration.
Market Landscape
Market Size and Growth
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The global AML treatment market was valued at approximately $1.2 billion in 2022 and projects compound annual growth rate (CAGR) of 8-10% over the next five years [1].
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The CLL market was estimated at $2.3 billion in 2022, with a projected CAGR of 7% [2].
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Venclexta's sales for 2022 totaled $1.7 billion, reflecting rapid adoption in hematological oncology.
Competitive Position
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Competitors include Ibrutinib (Imbruvica), Idelalisib, and newer agents like Acalabrutinib.
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The introduction of combination therapies (e.g., Venclexta with Gazyva or Rituximab) has expanded its usage.
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Regulatory approvals have extended its indications, supporting market penetration.
Price Trends and Projections
Current Pricing
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The wholesale acquisition cost (WAC) for Venclexta is approximately $13,000 per month for an average dose, translating to roughly $156,000 annually per patient.
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This pricing is comparable to other targeted cancer therapies, which typically range $120,000 to $200,000 annually.
Pricing Factors Influencing Trends
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Patent protections extend until at least 2028, delaying generic entry.
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Reimbursements and insurance coverage influence net prices in different markets.
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Combination therapies are increasing overall drug utilization and may influence pricing strategies.
Future Price Projections
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Given the current patent protection and high demand, retail prices are expected to remain stable or slightly increase by 2-4% annually over the next five years [3].
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Introduction of biosimilars or generics post-2028 could reduce prices by 20-30%, depending on market uptake.
Market Entry Dynamics and Pricing Impact
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Biosimilar competition is unlikely before 2028 due to patent exclusivity.
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Pricing pressures may emerge following patent expiry, driven by generic manufacturers.
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Market share shifts could occur if competing therapies demonstrate superior efficacy or safety profiles, potentially exerting downward pressure on prices.
Regulatory and Policy Considerations
Summary of Key Data
| Parameter |
Details |
| Current annual price per patient |
~$156,000 |
| Patent expiry |
2028 (expected for the US) |
| Market size (2022) |
AML: $1.2B; CLL: $2.3B |
| 5-year CAGR |
7-10% for market segments |
| Sales in 2022 |
~$1.7B |
Key Takeaways
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Venclexta holds a significant share of the hematologic cancer market, with steady demand.
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Prices are stable due to patent protections, with limited immediate price reductions anticipated.
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The upcoming patent expiration in 2028 is a potential point for price declines and increased competition.
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Market expansion into AML and combination regimens supports ongoing revenue growth.
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Competitive dynamics and policy shifts could alter pricing and market share over the next five years.
FAQs
1. When is the patent for NDC 52652-4001 set to expire?
Patent protections are expected to last until 2028 in the US, after which biosimilars could enter the market.
2. How does Venclexta compare price-wise to similar therapies?
It costs approximately $13,000 per month, aligning with other targeted oncology agents like Imbruvica and Calquence.
3. What are the main factors influencing future pricing?
Patent expiration, biosimilar entry, market demand, competition, and reimbursement policies.
4. Is there potential for price increases in the near term?
Yes, with stable demand, small annual price hikes of 2-4% are probable unless policy or market changes occur.
5. How might biosimilars affect the market post-2028?
They could reduce prices by 20-30% and increase access, potentially impacting Venclexta revenues.
Sources
[1] MarketWatch, “AML Market Size & Forecast,” 2022.
[2] Pfizer Oncology Reports, 2022.
[3] IQVIA, “Global Oncology Drug Pricing Trends,” 2022.
