Last updated: February 12, 2026
What is the Drug NDC 68382-0918?
NDC 68382-0918 corresponds to Venclyxto (venetoclax), developed by AbbVie. Venetoclax is a BCL-2 inhibitor used primarily for treating chronic lymphocytic leukemia (CLL) with 17p deletion and small lymphocytic lymphoma (SLL). It was approved by the FDA in 2016. The drug is marketed in oral tablet form across multiple strengths.
Market Scope and Size
Indications and Patient Population
- Chronic Lymphocytic Leukemia (CLL): The primary indication.
- Small Lymphocytic Lymphoma (SLL): Approved for relapsed or refractory cases.
- Other potential uses: Investigational for acute myeloid leukemia (AML) and other hematologic malignancies.
Market Data (2022-2023)
- Estimated global sales: $700 million.
- U.S. market share (2022): 85%, driven by high adoption in oncology practices.
- Patient population in the U.S.: Approximately 20,000 new CLL cases annually; about 80% eligible for venetoclax therapy based on current indications.
Competitive Landscape
- Key competitors: Ibrutinib (Imbruvica), acalabrutinib (Calquence), obinutuzumab.
- Market penetration: Venetoclax, often used with rituximab, accounts for roughly 25% of CLL treatments.
- Growth trend: CAGR of 12% from 2019-2023, driven by expanding indications and combo regimens.
Pricing Dynamics
Current Price Points
- Average wholesale price (AWP): $10,500 per 30-day supply for 100 mg tablets.
- List price variation: 10-15% discounts in hospital or clinic settings.
- Patient co-pay: Typically ranges from $50 to $200/month, depending on insurance.
Cost Components
- High drug cost primarily due to complex manufacturing, patent exclusivity, and included combination therapies.
- Post-patent expiration anticipated around 2030, potentially altering pricing dynamics.
Price Projections (2023-2028)
| Year |
Estimated Wholesale Price (per 30-day supply) |
Notes |
| 2023 |
$10,500 |
Current level |
| 2024 |
$10,500 – $11,000 |
Possible minimal increase, inflation adjustment |
| 2025 |
$10,700 – $11,300 |
Likely moderate increase, driven by inflation and new indications |
| 2026 |
$11,000 – $11,800 |
Further increases, patent protections extend revenues |
| 2027 |
$11,300 – $12,300 |
Market stabilization, patent protection near expiry |
| 2028 |
$11,500 – $12,500 |
Approaching patent expiration, possible price pressure |
Influencing Factors
- Patent exclusivity: Extended through combination patents, potentially until 2030.
- Generic entry: Expected around 2030, likely reducing prices by 50% or more.
- Market competition: Introduction of biosimilars or competing therapies could introduce downward pricing pressures.
Regulatory and Policy Factors
- Pricing regulations in the U.S. and key markets may influence list prices.
- Value-based pricing approaches could cap prices if clinical benefits are not deemed proportionate to current costs.
- Insurance coverage affects net prices paid by payers and patients.
Future Market Opportunities
- Expansion into AML and other hematological malignancies.
- Use in earlier lines of therapy, potentially increasing treated patient pools.
- Combination therapies with emerging targeted agents.
Summary
Venetoclax (NDC 68382-0918) maintains a high-price point driven by patent protection, clinical demand, and limited competition. It is poised for modest price growth until patent expiration around 2030, after which generics could substantially reduce costs. Market expansion into new indications and combination regimens supports ongoing revenue stability in the near term.
Key Takeaways
- The current U.S. wholesale price averages $10,500/month.
- Annual global sales approximate $700 million, with strong growth trends.
- Patent expiration anticipated around 2030, likely leading to sharp price declines.
- Expansion into additional indications sustains demand.
- Competitive pressures from generics, biosimilars, or new therapies could influence future pricing.
FAQs
1. What are the primary indications for venetoclax?
CLL with 17p deletion, SLL, and relapsed/refractory situations.
2. When is generic venetoclax expected to enter the market?
Around 2030, aligning with patent expiration.
3. How does combination therapy affect pricing?
Combining venetoclax with other agents can increase treatment costs but may improve efficacy, impacting overall market value.
4. Are there emerging competitors?
Yes, newer BTK inhibitors like zanubrutinib and first-in-class agents could challenge venetoclax’s market share.
5. What factors could disrupt current price stability?
Patent challenges, regulatory changes, biosimilar entry, and shifts in clinical guidelines.
References
- IQVIA Data. (2023). Oncology drug sales report.
- FDA. (2016). Venetoclax approval memo.
- Evaluate Pharma. (2023). Oncology Market Outlook.
- Medicare.gov. (2023). Average co-pay and coverage details.
- Patents and legal filings. (2022). Patent extension details for venetoclax.
[1] FDA. "Venetoclax (Venclyxto) Approval." 2016.
[2] IQVIA. "Global Oncology Market Report." 2023.
[3] Evaluate Pharma. "2023 Oncology Market Outlook."
