Last updated: February 26, 2026
What is the Drug Corresponding to NDC 51672-4036?
NDC 51672-4036 corresponds to a specific medication, which is identified by the National Drug Code (NDC). According to the FDA's database and public sources, this NDC represents Venclexta (venetoclax), a BCL-2 inhibitor used primarily for certain hematological malignancies such as chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).
Market Overview
Venclexta is developed and marketed by AbbVie. Its approval was granted by the FDA in 2016. The drug has gained significant market share due to its targeted mechanism and approval for multiple indications.
Current Market Size
- 2022 Revenue: Estimated at $2.45 billion globally, with the U.S. accounting for approximately 75% of sales.
- Market Penetration: Venclexta is the leading product in the BCL-2 inhibitor class, with over 80% market share within its approved indications.
- Competitive Landscape: Other therapies include Gilead's Trodelvy and AstraZeneca's Lynparza, but none directly compete within the same indication.
Key Factors Influencing Market Dynamics
- Additional Approvals: Expanded indications such as first-line treatment for CLL with 17p deletion and AML could extend sales.
- Competitive Pressure: Pending biosimilars or generic versions could impact pricing.
- Pricing & Reimbursement Policies: Variability by country affects net revenues.
- Pipeline Developments: Ongoing studies for solid tumors could diversify usage.
Price Data and Projections
Current Pricing
- United States: Average wholesale price (AWP) per 100 mg tablet is approximately $390, equating to a treatment course costing around $10,000 to $15,000, depending on dose and duration.
- Reimbursement: Insurance coverage and patient assistance programs influence actual treatment costs.
Setting Price Projections
Assuming minimal patent expiry risk before 2030 due to extended exclusivity and potential further approvals:
| Year |
Projected Price (US, per treatment course) |
Notes |
| 2023 |
$12,000 |
Current pricing; slight annual increases of 2% to 3%. |
| 2025 |
$12,600 |
Account for inflation and potential price adjustments. |
| 2030 |
$13,000 |
Expected to maintain or marginally increase. |
Revenue Projections (2023–2028)
Based on market penetration, pricing, and growth factors:
| Year |
Estimated Revenue (Billion USD) |
CAGR |
Assumptions |
| 2023 |
$2.6 |
— |
Slight growth from 2022, driven by expanded indications. |
| 2024 |
$2.8 |
8% |
Growth from new approvals, increased adoption. |
| 2025 |
$3.0 |
7% |
Market expansion continues, price stability. |
| 2026 |
$3.2 |
6% |
Possible entry of biosimilars, mitigated by brand loyalty. |
| 2027 |
$3.3 |
3% |
Market matures, growth slows. |
| 2028 |
$3.4 |
3% |
Stabilized growth expected; pipeline developments could influence further shifts. |
Market Risks and Opportunities
Risks
- Patent Expiry: Patent protection extends beyond 2028, with data exclusivity until at least 2030.
- Generic Competition: Entry of biosimilars or generics could pressure prices and revenue.
- Regulatory Changes: Reimbursement policies and drug pricing reforms could reduce margins.
- Pipeline Failures: If ongoing trials do not succeed, expansion prospects decline.
Opportunities
- Expanded Indications: Trials verifying efficacy in solid tumors could expand markets.
- Combination Therapies: Integrating venetoclax with other agents may increase treatment durations and patient populations.
- Geographic Expansion: Developing markets might see entry and pricing adjustments.
Key Takeaways
- NDC 51672-4036 correlates to Venclexta (venetoclax).
- Current global revenue approximates $2.5 billion, predominantly from the US.
- Pricing per treatment course remains stable but vulnerable to biosimilar entry.
- Revenue projections suggest modest growth through 2028, extending until patent expiration and biosimilar entry.
- Expansion into new indications could elevate sales but depends on clinical outcomes and regulatory approvals.
FAQs
1. How does patent protection affect future pricing? Patent protections typically last until 2029–2030 for Venclexta, preventing generic entry and supporting current pricing until then.
2. What impact could biosimilars have? Biosimilars could reduce prices by 20–40%, sharply decreasing revenue if adopted widely.
3. Are there upcoming regulatory decisions affecting Venclexta? Yes; approval of additional indications and label extensions could boost sales from 2024 onward.
4. How does treatment duration influence pricing? Longer durations increase total treatment costs, potentially improving revenue; shorter courses due to side effects could have the opposite effect.
5. What competitive advantages does Venclexta have? Its targeted mechanism, expanded indications, and market leadership position it favorably amid competition.
References
[1] FDA. (2022). NDC directories. Accessible at: https://www.fda.gov
[2] IQVIA. (2022). National Prescription Audit.
[3] MarketWatch. (2022). "Venclexta sales data."
[4] FDA. (2016). Approval of Venclexta for CLL.
[5] EvaluatePharma. (2022). "Top Oncology Drugs by Sales."
