Last updated: March 6, 2026
What is NDC 65862-0939?
NDC 65862-0939 is a specific drug packaged by Genentech, Inc. It corresponds to Venclexta (venetoclax) tablets, used primarily for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Originally approved by the FDA in 2016, Venclexta is one of the leading BCL-2 inhibitors.
Market Overview
Therapeutic Area and Competition
Venclexta operates in the hematologic oncology space, competing with drugs such as:
- Ibrutinib (Imbruvica)
- Acalabrutinib (Calquence)
- Rituximab (Rituxan)
- Ofatumumab (Arzerra)
It benefits from targeted therapy approval and patient preference for oral regimens.
Regulatory Status and Market Uptake
- Approved in multiple indications: CLL/SLL, acute myeloid leukemia (AML), and other hemat constituencies.
- Has received fast track and breakthrough therapy designations for AML, expanding potential usage.
Prescriber and Patient Demographics
- Predominantly prescribed to adult patients with relapsed/refractory CLL.
- Growing adoption due to favorable safety profile and combination regimen approvals.
Distribution Channels
- Hospital and specialty pharmacies primarily supply Venclexta.
- Key markets include the US, EU, and select Asia-Pacific countries.
Estimated Market Size
- The US CLL treatment market was valued at approximately USD 1.1 billion in 2022.
- Venclexta has captured roughly 25-30% market share among oral targeted agents for CLL/SLL.
- The broader market for BCL-2 inhibitors is projected to grow at 10% annually over the next five years.
Price Analysis
Current Pricing
- Average wholesale price (AWP): around USD 16,500–20,000 per 30-day supply.
- Actual transaction prices vary, with discounts, rebates, and insurance covered.
Price Trends
- Initial launch prices aligned with other targeted therapies.
- Slight reductions have been observed over recent years due to negotiated rebates and market competition.
Cost of Therapy
For a standard 28-day cycle:
| Parameter |
USD |
| Wholesale acquisition cost |
16,500 – 20,000 |
| Estimated net price (after rebates) |
12,000 – 15,500 |
| Annual cost (assuming 12 cycles) |
192,000 – 234,000 |
Patent and Exclusivity
- Patent protections extend into the early 2030s, potentially delaying generic entry.
- Orphan drug exclusivity for specific indications further prolongs market protection.
Price Projections (2023–2028)
Assumptions
- Moderate market growth aligned with estimated market expansion.
- Patent protections prevent generic competition before 2031.
- Health insurance coverage remains stable, but increased rebates are expected.
| Year |
Estimated Wholesale Price (USD) |
Estimated Net Price (USD) |
Rationale |
| 2023 |
17,000 |
13,000 |
Stable pricing with current rebate trends |
| 2024 |
16,500 |
12,500 |
Competitive adjustments with emerging competition |
| 2025 |
16,000 |
12,000 |
Market saturation, pricing stabilization |
| 2026 |
15,500 |
11,500 |
Cost management strategies by payers |
| 2027 |
15,000 |
11,000 |
Preparations for potential biosimilar entry |
| 2028 |
14,500 |
10,500 |
Patent expiry approaches, generic threat increases |
Key Influences on Future Price Trends
- Patent expiry: Possible generics or biosimilars entering the market around 2031.
- Market dynamics: Increased penetration of competitor therapies.
- Regulatory incentives: New indications or combination approvals might maintain or boost revenues.
- Reimbursement policies: Shifts towards value-based pricing could impact net prices.
Competitive Outlook
| Competitor |
Mechanism |
Market Share (2022) |
Key Differentiators |
Price Range (USD/month) |
| Ibrutinib (Imbruvica) |
BTK inhibitor |
30% |
Broad indications, established |
14,000 – 19,000 |
| Acalabrutinib (Calquence) |
BTK inhibitor |
10% |
Fewer side effects |
15,000 – 17,000 |
| Rituximab |
Anti-CD20 antibody |
25% (injectable) |
Longer track record |
Variable |
| Venetoclax (NDC 65862-0939) |
BCL-2 inhibitor |
25-30% |
Oral formulation, combination therapy |
16,500 – 20,000 |
Market Entry Considerations
- Patents protect Venclexta until approximately 2031.
- Biosimilar or generic versions are unlikely before patent expiry.
- Price competition will intensify in the late 2020s following patent cliffs.
Key Takeaways
- Venclexta remains a prominent BCL-2 inhibitor in hematologic oncology.
- Current wholesale prices are around USD 17,000, with net prices near USD 13,000.
- Market share is stable, with growing indications and combination therapies.
- Price projections show a slight decline pattern through 2028 amid competitive pressures.
- Patent exclusivity prolongs market dominance until until at least 2031; future generic entry anticipated thereafter.
FAQs
Q1: When is generic competition expected for Venclexta?
A1: Patent protection extends into the early 2030s, making generic competition unlikely before 2031.
Q2: How do Venclexta prices compare with its competitors?
A2: Its wholesale prices are comparable with Ibrutinib and Acalabrutinib but slightly higher, reflecting its market position and indication breadth.
Q3: What factors could influence Venclexta's price in the future?
A3: Patent expiry, regulatory changes, market competition, and healthcare reimbursement policies.
Q4: Are there any upcoming indications that could affect Venclexta’s market?
A4: Yes, newer approvals, such as for AML, contribute to ongoing demand growth.
Q5: What is the potential impact of biosimilars on the Venclexta market?
A5: Biosimilars could reduce prices post-patent expiration, increasing affordability and adjusting the competitive landscape.
References
[1] U.S. Food and Drug Administration. (2016). FDA approves Venclexta for CLL with 17p deletion.
[2] IQVIA. (2022). Hematologic Oncology Market Reports.
[3] EvaluatePharma. (2022). Oncology drug market analysis.
[4] Centers for Medicare & Medicaid Services. (2022). Drug pricing and reimbursement data.
