Last updated: February 21, 2026
What is NDC 70000-0464?
NDC 70000-0464 corresponds to a specific drug product designated by the National Drug Code (NDC). Based on current publicly available data, this NDC refers to Venclyxto ( Venetoclax), a BCL-2 inhibitor used for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, and acute myeloid leukemia (AML).
Market Overview
Therapeutic Area and Indications
Venetoclax is a targeted oral therapy with indications approved by the FDA since April 2016. It addresses unmet needs in hematological malignancies, especially in relapsed/refractory CLL and AML. Its mechanism of BCL-2 inhibition induces apoptosis in cancer cells.
Market size and growth drivers
- The global hematological malignancies market was valued at approximately USD 7.9 billion in 2022.
- A compound annual growth rate (CAGR) of around 8% is projected from 2023 to 2028.
Key growth drivers include:
- Rising incidence of CLL and AML.
- Expanded approvals for combinations, increasing treatment options.
- Innovation in BCL-2 targeting therapies.
Competitor landscape
Main competitors include:
- Ibrutinib (Imbruvica)
- Acalabrutinib (Calquence)
- Idelalisib (Zydelig)
- Other emerging BCL-2 inhibitors and combination therapies.
Venetoclax’s market share among targeted therapies in hematology remains substantial due to its efficacy and oral administration.
Pricing Analysis
Current Price Per Unit
According to recent prescription pricing data (Medicare Part B and retail pharmacy pricing), the approximate wholesale acquisition cost (WAC) is:
| Measure |
Price (USD) |
| Monthly Cost |
$13,399 |
| Cost Per 28-day Supply |
$13,399 |
This premium reflects its novel mechanism, orphan drug status, and patent exclusivity.
Price Comparisons
Compared to competitors:
- Ibrutinib (Imbruvica): ~$11,390/month.
- Acalabrutinib (Calquence): ~$13,122/month.
- Idelalisib (Zydelig): ~$8,576/month, but less used in practice.
Venetoclax’s high price correlates with its patent status, clinical efficacy, and targeted therapy designation.
Price Trends
- No significant recent price reductions.
- Manufacturers have maintained high prices post-approval due to limited generic competition.
- Patent expiration expected around 2030, with biosimilar and generic entry possible afterward.
Market Penetration and Reimbursement
- Major payers, including CMS and private insurers, reimburse based on negotiated rates.
- Cost-effectiveness analyses support its use due to survival benefits.
- Patient access programs mitigate out-of-pocket costs for some populations.
Future Price Projections
Short-term (2023-2025)
- Stable pricing expected due to patent protection.
- Slight upward pressure could result from inflation and supply chain costs.
Medium to Long-term (2026-2030)
- Entry of biosimilars or generics post-patent expiration could reduce prices by 30–50%.
- Competitive market dynamics may increase downward pressure.
- Price drops likely to accelerate as biosimilars gain market share and therapy costs decline.
Factors Influencing Future Pricing
- Regulatory decisions on biosimal approval.
- Market uptake in broad indications.
- Reimbursement policy adjustments.
- Clinical trial outcomes for next-generation therapies.
Summary of Financial Outlook
| Year |
Estimated Market Size (USD) |
Estimated Price Per 28-day Supply (USD) |
| 2023 |
$2.7 billion |
$13,399 |
| 2025 |
$3.2 billion |
$13,399 |
| 2028 |
$4.0 billion |
Possible decline to ~$8,500 with biosimilar entry |
Conclusion
NDC 70000-0464, representing venetoclax, commands high prices driven by its targeted efficacy and lack of competition. Its market remains robust, with prices expected to stay stable until patent expiration, after which biosurfamilar competition may significantly reduce costs.
Key Takeaways
- Venetoclax's current market price is approximately $13,399/month.
- It holds a dominant position in hematological malignancy therapy due to its efficacy.
- Patent expiry anticipated around 2030, likely leading to price reductions.
- Market growth driven by increased incidence and expanded indications.
- Future prices could decline 30–50% post-patent, with biosimilar entry.
FAQs
-
What is the primary indication for venetoclax?
Venetoclax is used for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, and acute myeloid leukemia (AML).
-
How does the price of venetoclax compare with similar therapies?
Its price (~$13,399/month) is comparable to other targeted BCL-2 inhibitors like acalabrutinib but higher than some alternatives such as idelalisib.
-
When might biosimilars or generics enter the market?
Post-2030, following patent expiration, generics and biosimilars could significantly reduce prices.
-
What factors influence luting future market share for venetoclax?
Factors include additional approvals, combination therapies, patent status, and competitive entries.
-
What is the current market value for venetoclax?
The market value is approximately USD 2.7 billion in 2023, with projections to increase as indications expand.
References
[1] U.S. Food and Drug Administration. (2016). FDA approves Venclyxto for chronic lymphocytic leukemia.
[2] MarketWatch. (2022). Hematological malignancies market size, growth, and forecasts.
[3] Centers for Medicare & Medicaid Services. (2023). Prescription drug pricing data.
[4] IQVIA. (2023). U.S. prescription trends and drug pricing analyses.
[5] EvaluatePharma. (2022). Oncology market forecasts and biosimilar impact projections.
