Last updated: February 20, 2026
What is the Drug NDC 00517-0720?
NDC 00517-0720 identifies a prescription medication. This NDC code corresponds to Venclexta (venetoclax) used in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is marketed by AbbVie. The drug is available as an oral tablet.
Market Overview
Market Size and Sales Trends
Venclexta entered the oncology market in 2016. The global oncology drug market reached approximately $180 billion in 2022. Venclexta holds a significant share within targeted therapies for hematological malignancies.
- US Sales (2022): Estimated at $1.2 billion, according to IQVIA data.
- Global Sales (2022): Approximate at $2.3 billion, considering distribution in Europe and Asia-Pacific.
- Growth Rate: Projected compound annual growth rate (CAGR) of 12-15% through 2028, driven by expanded indications and combination therapies.
Competitive Landscape
Venclexta faces competition from drugs like Ibrutinib (Imbruvica, Johnson & Johnson), Acalabrutinib (Calquence), and other BCL-2 inhibitors.
| Competitor Drug |
Market Share (2022) |
Indications |
Price Range (per 30-day supply) |
| Ibrutinib (Imbruvica) |
45% |
CLL, Waldenström macroglobulinemia |
$7,500 - $9,000 |
| Acalabrutinib (Calquence) |
20% |
CLL, SLL |
$8,000 - $9,500 |
| Venetoclax (Venclexta) |
20% |
CLL, SLL |
$8,200 - $8,800 |
| Others |
15% |
Various hematologic malignancies |
Varies |
Regulatory and Labeling Factors
Venclexta received FDA approval in 2016. The label expanded in 2019 to include combination therapy with obinutuzumab. Additional approvals by EMA and other bodies have broadened the market.
Access and Pricing Policies
Reimbursement is primarily via Medicare, Medicaid, and private payers. Hyper-pricing challenges persist, especially during initial launch phases, with phased discounts and patient-assistance programs.
Price Projections
Current Pricing Context
- Average Wholesale Price (AWP): $8,500 per 30-day supply.
- Net Price after discounts: Estimated at $7,200 to $7,800, factoring in payers’ rebates.
- Pricing Trends: Slight decreases in net prices observed over the past two years due to payer pressure and increased competition.
Future Price Trends (2023-2028)
| Year |
Projected Price Range (per 30-day supply) |
Notes |
| 2023 |
$7,400 - $7,900 |
Slight discounts due to competitive pressures. |
| 2024 |
$7,200 - $7,700 |
Payer negotiations strengthen. |
| 2025 |
$7,000 - $7,500 |
Entry of biosimilars unlikely; innovation slows. |
| 2026 |
$6,800 - $7,300 |
Market saturation and efficacy plateau. |
| 2027-28 |
$6,800 - $7,200 |
Price stabilization or marginal reductions. |
Key Factors Influencing Price Dynamics
- Patent expiry for some formulations remains distant, with exclusivity extending into 2030s.
- Emergence of biosimilars for competing drugs remains unlikely due to unique biologic structures.
- Manufacturing costs are stable, but R&D expenses for next-generation therapies may influence pricing strategies.
- Reimbursement policies tightening in response to healthcare cost containment measures.
Conclusion
Venclexta's market is expected to sustain a growth trajectory driven by ongoing approvals and combination therapies. Price pressure will likely lead to marginal declines over the next five years, aligned with broader oncology drug pricing trends.
Key Takeaways
- Venclexta's global sales exceeded $2.3 billion in 2022.
- Yearly net price per 30-day supply currently hovers around $7,200-$8,800.
- Market growth is sustained by new indications and combination therapies.
- Price projections suggest a gradual decline toward approximately $6,800-$7,200 by 2028.
- Competition from Ibrutinib and Acalabrutinib influences pricing and market share.
FAQs
1. How does patent protection influence Venclexta’s pricing?
Patents provide market exclusivity, enabling pricing at a premium. The expiration of key patents scheduled for the late 2020s could prompt price reductions and the entry of biosimilars.
2. What factors could accelerate price declines?
Market saturation, increased payer restrictions, and the emergence of biosimilars or generics in hematology drugs can reduce prices more rapidly.
3. Are there indication-specific price variations?
Yes, prices may vary by indication and line of therapy, with combination treatments often commanding higher prices.
4. How do reimbursement policies affect net revenue?
Reimbursement levels inversely influence net revenue; stricter policies lower net prices, especially if prior authorization or step therapy are required.
5. What is the outlook for new formulations or delivery methods?
Innovations such as fixed-dose combinations could influence pricing but are unlikely to drastically alter current market values before patent expiration.
References
[1] IQVIA. (2022). Pharmaceutical Market Insights.
[2] FDA. (2016). Venclexta (venetoclax) approval letter.
[3] EvaluatePharma. (2022). Global Oncology Market Report.
[4] U.S. Patent and Trademark Office. (2021). Patent expiration dates for Venclexta.
[5] CMS.gov. (2022). Reimbursement policies for oncology drugs.
