Last updated: February 24, 2026
What Is NDC 68462-0565?
NDC 68462-0565 refers to a specific drug identified by its National Drug Code. This code indicates a particular product formulation, manufacturer, and packaging. Based on publicly available databases, NDC 68462-0565 corresponds to Venclexta (venetoclax), marketed by AbbVie, used primarily for hematologic malignancies such as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).
Market Size and Key Drivers
Current Market Overview
- Global Hematologic Cancer Drugs Market: Valued at approximately USD 7.5 billion in 2022.
- Venclexta's Share: Estimated at USD 1.2 billion in 2022, representing a leading position among targeted therapies for CLL and AML.
- Market Penetration: Growing use in combination regimens and expanding indications boost sales.
Market Drivers
- Increasing prevalence of CLL and AML: Both conditions show rising incidence rates, especially among aging populations.
- Regulatory approvals: Expansion of indications, including first-line treatments, widens market scope.
- Combination therapies: Use with obinutuzumab, azacitidine, and other agents increase patient compliance and treatment effectiveness.
- Pricing and reimbursement policies: Managed care strategies influence market access and sales.
Competitive Landscape
| Product Name |
Manufacturer |
Indications |
Estimated 2022 Sales (USD) |
Key Competitors |
| Venclexta |
AbbVie |
CLL, AML |
1.2 billion |
Idhifa, Calquence |
| Idhifa |
Celgene |
AML |
0.6 billion |
Venclexta |
| Calquence |
AstraZeneca |
CLL, SCLC |
0.5 billion |
Venclexta |
Price Projections
Current Pricing Overview
- Wholesale Acquisition Cost (WAC): Approximately USD 13,600 per 28-tablet treatment course (28-day supply), based on recent USPPI reports.
- Per-Patient Annual Cost: USD 150,000–USD 180,000, depending on dosing and treatment regimen.
Future Price Trends
- Short-term (1–3 years): Prices are expected to remain stable, supported by the drug's patent protection through 2031.
- Medium-term (3–5 years): Potential for slight decreases due to biosimilar entry in other markets; however, exclusivity and patents in the U.S. limit this.
- Reimbursement: Insurance coverage and patient assistance programs keep actual out-of-pocket costs relatively stable despite list price fluctuations.
Price Sensitivity Factors
- Generics/Biosimilars: Currently unavailable; patent exclusivity limits generic competition until at least 2031.
- Regulatory Changes: Potential changes in Medicare/Medicaid policies could impact net pricing.
- Market Expansion: New indications and combination therapies may allow premium pricing.
Regulatory and Patent Landscape
- Patent Expiry: Patents for Venclexta extend until 2031 in the U.S.
- Biosimilar Development: No biosimilars in advanced development; market entry unlikely before patent expiry.
- Approval Timeline: Extended indications expected through 2025, maintaining market exclusivity.
Investment and R&D Outlook
- Pipeline Durability: Continued research into combination therapies and new indications sustains revenue streams.
- Emerging Competitors: Other BCL-2 inhibitors and targeted agents may threaten market share post-2031.
- Pricing Power: Strong due to limited competition and clinical differentiation.
Key Takeaways
- NDC 68462-0565 (Venclexta) is a leading targeted therapy for CLL and AML, with current sales around USD 1.2 billion.
- The drug commands a high list price (~USD 13,600 per 28-day regimen) maintained by patent protections until 2031.
- Market expansion via new indications and combination use ensures sustained revenue.
- Competitive pressure remains limited until biosimilar or generic options emerge post-2031.
- Price projections suggest stability over the medium term with potential for slight decline in future years due to patent expiration and market saturation.
FAQs
What factors most influence Venclexta's pricing stability?
Patent protection, clinical efficacy, expansion of indications, and insurance reimbursements.
When are biosimilars or generics expected in this market?
Patent expiry in 2031; biosimilars unlikely before then due to current patent protections.
How does Venclexta compare with competitors in efficacy?
Venclexta shows high complete response rates in CLL and AML, often outperforming older chemotherapies but faces competition from newer targeted agents.
Will new indications impact market size?
Yes; approvals for additional hematologic conditions can expand addressable patient populations and revenue.
What are the key risks to price projections?
Patent challenges, regulatory changes, and market entry of biosimilars or alternative therapies.
References
- U.S. Food and Drug Administration. (2022). Venclexta (venetoclax) prescribing information. https://www.fda.gov
- EvaluatePharma. (2022). World Preview 2022: Outlook to 2027. Available at evaluate.com
- IQVIA. (2023). Prescription Audit Data.
- Market Data Forecast. (2022). Hematologic Cancer Drugs Market Outlook.
