Last updated: February 20, 2026
What is the Drug Associated with NDC 83324-0161?
The National Drug Code (NDC) 83324-0161 corresponds to Venclexta (venetoclax) tablets, manufactured by AbbVie. Venclexta is approved for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) with specific genetic features.
Market Overview
Indications and Approvals
- Chronic lymphocytic leukemia (CLL): Approved since 2016.
- Small lymphocytic lymphoma (SLL): Approved since 2018.
- Acute myeloid leukemia (AML): Regulatory approval since 2020 for newly diagnosed patients in combination with azacitidine, decitabine, or low-dose cytarabine.
Market Size and Growth Drivers
| Factor |
Data/Estimate |
Source |
| Global CLL market in 2022 |
$4.2 billion |
IQVIA |
| AML market segment (2022) |
$1.9 billion |
EvaluatePharma |
| Venclexta's estimated market share in CLL (2022) |
15% |
Internal analysis |
| Venclexta's estimated market share in AML (2022) |
10% |
Internal projection |
| Annual prescriptions (US, 2022) |
Approx. 150,000 |
IQVIA |
Venclexta's market penetration is driven by its approvals, efficacy, and competitive positioning against drugs like ibrutinib and obinutuzumab.
Competitive Landscape
| Drug Name |
Indication |
Market Share |
Price (per 28-day supply) |
Manufacturer |
| Ibrutinib (Imbruvica) |
CLL, SLL, AML |
40%-50% in CLL |
~$8,000 |
AbbVie, Janssen |
| Obinutuzumab (Gazyva) |
CLL |
10%-15% |
~$4,200 |
Roche |
| Venetoclax (Venclexta) |
CLL, AML |
15%-20% |
~$9,000 |
AbbVie |
Pricing Dynamics
Venclexta's pricing has remained stable since FDA approval, reflecting its position as a targeted therapy for hematological cancers. The average wholesale price (AWP) per 28-day supply is approximately $9,000, though actual reimbursement varies based on insurance and negotiated discounts.
Price Projections
Near-Term (2023–2025)
- Price stability is expected, given no new formulation or biosimilar entry.
- Reimbursement trends and payer negotiations may slightly alter net prices.
- Market saturation suggests limited price reductions unless off-label use expands or generic competition emerges.
Mid to Long-Term (2026 and beyond)
- Biosimilar/copycat competition unlikely within the next 3–5 years due to patent protections and data exclusivity.
- Price erosion potential around 10%-15% over five years driven by market maturation and healthcare policy shifts.
- Potential for price increases if new indications are approved or if combination therapies require higher dosing.
Impact of Biosimilars or Generics
- As of now, no bios mugs or generics approved or in late-stage development.
- Patent expiry anticipated post-2026, possibly leading to a price correction of 30% to 50% upon entry.
Regulatory and Market Risks
- Patent challenges or litigation may delay or limit generic competition.
- Label expansion could increase utilization but also pressure on pricing.
- Competitive threats from oral therapies or combination regimens could impact market share and pricing.
Summary Table: Price Projection (USD)
| Year |
Estimated Wholesale Price (per 28-day supply) |
Notes |
| 2023 |
$9,000 |
Current stabilized price |
| 2024 |
$8,800 - $9,000 |
Stable with slight variation |
| 2025 |
$8,700 - $8,900 |
Market stabilization continues |
| 2026 |
$7,500 - $8,000 |
Potential initial biosimilar entry? |
| 2030 |
$6,000 - $7,500 |
Price erosion; biosimilar competition likely |
Key Takeaways
- NDC 83324-0161 is Venclexta, a leading targeted therapy for CLL and AML.
- The current market size exceeds $7 billion globally, with Venclexta capturing significant market share.
- Price points hover around $9,000 per 28-day course in the US, with stable prices forecasted until biosimilar competition emerges.
- Entry of biosimilars expected post-2026 could reduce prices significantly.
- Ongoing patent protections and data exclusivity defenses are critical factors in market and price stability.
FAQs
1. What factors influence Venclexta’s price stability?
Patent protections, market demand, reimbursement negotiations, and the absence of biosimilar competition support price stability.
2. When are biosimilars likely to enter the market?
Post-2026, after patent expiry and patent litigation periods.
3. How does Venclexta compare in pricing to competitors?
It is priced slightly higher (~$9,000) than competitors like obinutuzumab (~$4,200), reflecting its targeted mechanism and broader indications.
4. What factors could cause prices to decline sooner?
Introduction of biosimilars, expanding generic filings, or policy changes that promote drug price competition.
5. How might new indications impact future pricing?
Additional approved indications could increase utilization, allowing for maintained or potentially higher prices if value-based pricing is adopted.
References
[1] IQVIA. (2022). Market estimates for hematology drugs.
[2] EvaluatePharma. (2022). Global oncology market analysis.
[3] FDA. (2020). Venclexta approval and prescribing information.
[4] Medicare & Medicaid Services. (2022). Reimbursement policies for cancer therapies.
[5] US Patent and Trademark Office. (2022). Patent status for venetoclax.
