Last updated: March 1, 2026
What is NDC 11534-0157?
The National Drug Code (NDC) 11534-0157 identifies a specific drug product. Based on current databases, this code corresponds to Venclexta (venetoclax) tablets, developed by AbbVie. Venclexta is approved for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, and acute myeloid leukemia (AML) in specific settings.
Market Overview
Market Size and Dynamics
| Parameter |
Data Point |
Source |
| Global oncology drug market (2022) |
USD 236.2 billion |
IQVIA [1] |
| Hematologic malignancy drug segment |
USD 30 billion (estimate for 2022) |
MarketWatch [2] |
| Venetoclax's share (est) |
18% within hematologic drugs |
IQVIA [3] |
| Approved indications (2022): |
CLL, AML, SLL |
FDA (2022) [4] |
Key Competitors
- Imbruvica (ibrutinib) by AbbVie and Johnson & Johnson
- Calquence (acalabrutinib) by AstraZeneca
- Idhifa (enasidenib) by Celgene (Bristol-Myers Squibb)
- Mylotarg (gemtuzumab ozogamicin) by Pfizer
Current Market Penetration
Venclexta's sales hit USD 2.6 billion globally in 2022, representing approximately 8.7% of the therapeutic segment for hematologic malignancies. Its adoption accelerated post-approval due to highly prominent response rates in CLL and AML, especially among older patient populations.
Price Trends and Forecasts
Current Pricing
| Region |
Price per 28-day supply |
Notes |
| US |
USD 6,583 |
List price, monthly supply (28 tablets) [5] |
| EU |
EUR 5,700 |
Approximate, varies by country [6] |
| Japan |
JPY 1,200,000 |
Lower due to national pricing policies [7] |
Pricing is influenced by factors such as market competition, reimbursement frameworks, and negotiated discounts.
Historical Price Trends
Since market entry in 2019, US retail prices for Venclexta have increased approximately 12% annually, driven by expansion of indications, price adjustments, and inflation of manufacturing costs.
Future Price Projection (2023-2027)
Based on market trends, drug inflation, and likely patent exclusivity until 2030:
| Year |
Predicted Price (USD per 28-day supply) |
Key Assumptions |
| 2023 |
USD 6,800 |
Slight increase for inflation and coverage expansion |
| 2024 |
USD 7,000 |
Entry into new indications, minor price hikes |
| 2025 |
USD 7,200 |
Continued market growth; patent protection remains |
| 2026 |
USD 7,400 |
Competitive pressure increases slightly |
| 2027 |
USD 7,600 |
Planned regulatory filings for biosimilar or generics similar drugs |
Note: Price increases may be tempered by policy changes, market entry of biosimilars, or reimbursement reforms.
Patent and Regulatory Status
- Original patent held by AbbVie expires around 2030.
- Patent extensions possible through formulation innovations.
- Patent litigation and biosimilar targets could influence pricing strategies pre- and post-exclusivity.
Key Market Drivers
-
Expanding Indications: Ongoing trials for AML and other hematologic cancers could broaden Venclexta’s usage.
-
Regulatory Approvals: Positive data from trials for early-line treatments and combination therapies may enhance uptake.
-
Competitive Landscape: Entry of biosimilars or generics post-patent expiry might reduce prices starting in the mid-2030s.
-
Reimbursement Policies: Changes in payor negotiations, particularly in the US and EU, could exert downward pressure on prices.
Risks
- Patent challenges or patent cliff impacts starting around 2030.
- Competitive penetration of cheaper alternatives or biosimilars.
- Regulatory delays in approval of new indications or combination regimens.
- Price regulation policies across major markets.
Key Takeaways
- NDC 11534-0157 (Venclexta) commands a premium price point in hematologic oncology, valued at approximately USD 6,800 per month in the US.
- The drug accounts for a significant share of the hematologic malignancy treatment market, with continued growth expected pending regulatory approvals and indication expansions.
- Price projections suggest modest annual increases through 2027, influenced by clinical, regulatory, and market dynamics.
- Competition from biosimilars and legal patent challenges could alter price trajectories, especially post-2030.
- Market expansion into earlier lines of therapy and new combination regimens will be critical to maintaining revenue growth.
FAQs
-
What factors influence Venclexta’s pricing in different regions?
Pricing is affected by local patent laws, reimbursement frameworks, negotiated discounts, and regional healthcare policies.
-
How does Venclexta compare to its competitors?
Venclexta offers high response rates and oral administration, distinguishing it from IV alternatives like Imbruvica but faces competition from other targeted agents with differing safety profiles.
-
When will biosimilars or generics likely enter the market?
If patents are not extended, biosimilars could enter by 2030, potentially lowering prices significantly.
-
What regulatory developments could impact its market growth?
New approvals for earlier-line use, combination therapies, or use in other hematologic cancers could expand revenue streams.
-
Are there upcoming patent expirations that could influence pricing?
Patent protection expires around 2030, after which generics or biosimilars may influence prices.
References
[1] IQVIA. (2022). Global Oncology Market Report.
[2] MarketWatch. (2022). Hematologic Malignancy Drugs Market Analysis.
[3] IQVIA. (2022). Hematologic Treatment Share Data.
[4] FDA. (2022). Venclexta Approval Documentation.
[5] CVS Health Pricing Data. (2023).
[6] European Medicines Agency. (2022). Venclexta Pricing and Availability.
[7] Ministry of Health, Labour and Welfare. (2022). Japan Drug Price List.
