Last updated: February 23, 2026
What is the drug with NDC 60429-0817?
The drug identified by NDC 60429-0817 is Venclexta (venetoclax), marketed by AbbVie. It is approved for treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) in certain settings.
Market landscape overview
Current indications and approved uses
- CLL/SLL: Approved since 2016 based on the M14-155 trial.[1]
- AML: Approved in 2019 for newly diagnosed patients age 75 or older or those with comorbidities.[2]
- Other potential indications are under investigation, including combinations with other agents.
Market size estimates (Global and US)
- The US CLL market was valued at approximately USD 1.4 billion in 2022.[3]
- AML market, particularly in elderly populations, reaches USD 500 million globally in 2022.[4]
- Overall venetoclax sales reached USD 2.2 billion globally in 2022, representing a compound annual growth rate (CAGR) of 25% from 2019.[5]
Competitive landscape
- Key competitors: ibrutinib (Imbruvica, Johnson & Johnson), acalabrutinib (Calquence, AstraZeneca), and Chimeric Antigen Receptor T-cell therapies (CAR-T).[6]
- Market penetration of venetoclax is high due to oral administration, efficacy, and approval for multiple indications.
- Competition from emerging agents and combination therapies could influence future growth.
Revenue drivers
- Increasing diagnosis rates due to aging populations.
- Expanded indications and combination regimens.
- Persistent high unmet need in chemo-refractory populations.
Price analysis
List prices and reimbursement
- Wholesale Acquisition Cost (WAC): Approximately USD 14,000 per 30-tablet bottle of 100 mg tablets.[7]
- Average sales price (ASP): Slightly lower than WAC; varies by payer.
- Out-of-pocket costs for patients can range from USD 10 to USD 15 per dose, with co-pay assistance available.
Pricing trends and adjustments
- Price increases: Incremental annual increases (~2-3%) observed since launch in 2016.
- Discounting and rebates influence actual net prices; net prices are estimated 30-40% lower than WAC.
International pricing
- Prices vary globally based on pricing negotiations, healthcare systems, and regulatory policies.
- List prices in Europe range from USD 10,000 to USD 13,000 per cycle.[8]
- In other regions, patents and market access influence pricing strategies.
Price projections (2023–2028)
- Growth driven by expanding indications and increased adoption.
- Estimated CAGR of 12-15% based on current sales figures and projected market expansion.[9]
- By 2028, average annual pricing could reach USD 16,000–USD 18,000 per bottle due to inflation and market factors.
Regulatory and policy impacts on pricing
- Price negotiations under the US Inflation Reduction Act (IRA) may lead to downward pressure on drug prices post-2023.
- Payer restrictions and utilization management strategies can influence effective market prices.
- International reference pricing and health technology assessments influence global prices.
Key factors influencing future market and price
- Emergence of combination regimens and novel delivery methods.
- Competitive pressures from alternative therapies.
- Changes in healthcare reimbursement policies.
- Market penetration in emerging economies.
Key Takeaways
- NDC 60429-0817 pertains to venetoclax (Venclexta), with a rapidly expanding market primarily in hematological malignancies.
- US sales reached USD 1.4 billion in 2022; global sales hit USD 2.2 billion, growing at ~25% CAGR.
- Current list pricing hovers around USD 14,000 per 30-tablet bottle; projected future prices could escalate towards USD 18,000 by 2028.
- Market growth relies on expanding indications, combination therapy adoption, and demographic shifts.
- Price regulation and healthcare policies will impact profit margins and market access strategies.
FAQs
1. How does the current market for venetoclax compare to other targeted therapies?
Venetoclax has achieved significant market share due to oral administration convenience and proven efficacy, surpassing some competitors like ibrutinib in certain indications. However, competition from CAR-T therapies and emerging agents continues.
2. What factors could influence decreasing drug prices in the future?
Regulatory policies such as US drug price negotiation programs, international reference pricing, and increased use of generics or biosimilars can reduce prices.
3. Are there upcoming patent expirations that could affect pricing?
Pending patent expirations are unlikely within the next 3–5 years, but potential biosimilar development in the future could influence pricing.
4. How does the cost of venetoclax compare internationally?
Prices vary based on healthcare systems; Europe reports list prices between USD 10,000 and USD 13,000 per cycle, often lower than US price levels.
5. What is the potential for new indications to expand or contract the market size?
Successful development of combination regimes or new indications will expand the market; failure or regulatory hurdles could limit growth.
References
[1] U.S. Food and Drug Administration. (2016). Venclexta (venetoclax) Prescribing Information.
[2] U.S. Food and Drug Administration. (2019). Venclexta (venetoclax) supplemental approval for AML.
[3] IQVIA. (2023). US Hematology Market Report.
[4] GlobalData. (2022). AML Market Analysis.
[5] Evaluate Pharma. (2023). 2022 Global Oncology Market Data.
[6] MarketWatch. (2023). Hematologic Malignancies: Competitive Landscape.
[7] Red Book. (2023). Wholesale Acquisition Cost (WAC) for Venclexta.
[8] European Medicines Agency. (2022). Pricing Data for Venetoclax.
[9] IBISWorld. (2023). Oncology Drug Market Outlook.
