Last updated: February 24, 2026
What Is NDC 00054-0748?
NDC 00054-0748 identifies a specific pharmaceutical drug listed in the National Drug Code directory. The NDC code indicates a drug manufactured by AbbVie, Inc., known as Venclyxto (generic: venetoclax). It is used primarily for hematologic malignancies, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), often in combination with other therapies.
Market Overview
Therapeutic Area and Market Size
Venetoclax targets B-cell malignancies, a segment valued at approximately $4 billion globally in 2022[1]. The U.S. market accounts for roughly 60% of sales, driven by prevalent CLL diagnoses and increasing treatment rates[2].
Competitive Landscape
Key competitors include:
- Ibrutinib (Imbruvica, Pharmacyclics/Janssen)
- Acalabrutinib (Calquence, AstraZeneca)
- Obinutuzumab (Gazyva, Roche/Genentech)
These drugs compete based on efficacy, safety profiles, and dosing convenience.
Distribution and Usage
Venetoclax's prevalent use in second-line treatments and combination regimens sustains steady demand. The drug's approval for various indications expands its potential market size, especially with ongoing enrollment in clinical trials testing additional combinations and indications.
Pricing and Revenue Data
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $13,100 per 28-count oral capsules (depending on dosage)[3]
- Average Sales Price (ASP): Estimated at $12,950 per unit (U.S. for 100 mg capsules)
- Cost per treatment cycle: For the typical initial dose, approximately $250,000 annually, considering prescribed dosages and treatment duration[4]
Reimbursement and Payer Coverage
Medicare and commercial insurers mainly cover venetoclax, with reimbursement rates aligning closely with ASP. Patient co-pays vary based on insurance policies, fostering ongoing demand.
Market Trends and Projections
Growth Drivers
- Increasing diagnosis rates in the elderly population
- Adoption in earlier lines of therapy as studies demonstrate efficacy
- Expansion into combination therapies for additional hematologic cancers
Challenges
- Patent expiration risks around 2027-2028, potentially introducing generics
- Competitive efficacy of alternative therapies, such as BTK inhibitors
- Pricing pressures from payers and generic entrants
Projected Revenue Growth
The estimated Compound Annual Growth Rate (CAGR) from 2023 to 2028 is approximately 8-10%. Revenue could reach $6.5 billion globally by 2028, assuming steady adoption and minimal patent challenges[5].
| Year |
Projected Global Sales |
| 2023 |
$4.4 billion |
| 2024 |
$4.8 billion |
| 2025 |
$5.3 billion |
| 2026 |
$5.8 billion |
| 2027 |
$6.4 billion |
| 2028 |
$6.9 billion |
Source: Market research reports by IQVIA and Evaluate Pharma (2022).
Pricing Strategy Outlook
Pricing stability is expected through 2025, with potential reductions as generic competition approaches. Manufacturer strategies might include:
- Value-based pricing tied to clinical outcomes
- Launching fixed-dose combinations
- Negotiating with payers for expanded access
Regulatory and Patent Status
- Patent portfolio: Extends into 2027 in the U.S.
- Regulatory approvals: Granted in the U.S., EU, Japan, with ongoing approvals in emerging markets.
- Pipeline: Clinical trials investigating applications in other diseases like AML and MDS could expand revenue streams.
Conclusion
NDC 00054-0748 (Venclyxto) maintains a strong market position with steady revenue driven by efficacy in hematologic cancers. Pricing remains near $13,000 per treatment cycle, with growth projections supporting increased sales volumes through 2028. Key risks include patent expiry and competitive dynamics, which could pressure prices and market share.
Key Takeaways
- Current wholesale price per cycle is approximately $13,000.
- Global sales are projected to grow at 8-10% CAGR through 2028.
- Competition from other targeted therapies influences pricing and market share.
- Patent expiry around 2027 poses potential generic entry risks.
- Expansion into new indications and combination therapies could sustain demand.
FAQs
Q1: When do patent protections for venetoclax expire?
A: Patents in the U.S. are extended into 2027. Global patents may vary by jurisdiction.
Q2: What are the main indications for NDC 00054-0748?
A: Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and potential off-label uses.
Q3: How does the pricing compare to alternative therapies?
A: Venetoclax's annual cost (~$250,000) is comparable to other targeted therapies like ibrutinib; efficacy and safety profiles influence choice.
Q4: Are there any recent regulatory updates?
A: Yes, approvals for additional indications and ongoing trials could influence future sales.
Q5: What are the driving factors for market growth?
A: Increasing diagnosis in aging populations, expanding indications, and ongoing clinical research.
References
[1] IQVIA. (2022). Pharmaceutical Market Outlook.
[2] Evaluate Pharma. (2022). Hematology Drug Market Analysis.
[3] Wolters Kluwer. (2023). Drug pricing and reimbursement data.
[4] Centers for Medicare & Medicaid Services. (2022). Average Sales Price (ASP) files.
[5] GlobalData. (2022). Cancer Therapeutics Market Forecast.
