Last updated: February 20, 2026
What is NDC 64380-0173?
NDC 64380-0173 designates a specific drug product identified by the National Drug Code (NDC) system maintained by the FDA. Based on the code, this product is a biologic, likely a monoclonal antibody or similar advanced therapeutic, utilized in specific indications such as autoimmune diseases or cancers.
Primary derivation indicates it is marketed as Venclexta (venetoclax) tablets, used mainly for hematologic malignancies like chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
What is the Current Market Scope?
U.S. sales data position venetoclax as a leading targeted therapy in hematology. In 2022, the drug generated approximately $4.3 billion in gross sales nationwide. The global market exceeds $6 billion, with the dominant share held by the U.S. due to high clinical adoption and reimbursement coverage.
Indications
- Chronic lymphocytic leukemia (CLL)
- Small lymphocytic lymphoma (SLL)
- Acute myeloid leukemia (AML) (off-label)
Competitive Products
Key competitors include:
| Product Name |
Manufacturer |
Indications |
Approximate 2022 Sales (USD) |
| Imbruvica (ibrutinib) |
Pharmacyclics/J&J |
Multiple B-cell malignancies |
3.8 billion |
| Gazyva (obinutuzumab) |
Roche |
CLL, follicular lymphoma |
2.1 billion |
| Calquence (acalabrutinib) |
AstraZeneca |
CLL, mantle cell lymphoma |
1.5 billion |
Venetoclax's market share has been expanding due to its favorable efficacy profile and targeted mechanism.
Market Drivers and Constraints
Drivers
- Expanding indications, including AML and other hematologic malignancies.
- Broadened reimbursement coverage, including private and Medicare plans.
- Growing adoption owing to oral administration and improved safety profile.
- Launch of combination therapies with venetoclax enhancing effectiveness.
Constraints
- High drug price (list price approximately $13,000 per month for the 100 mg tablets).
- Competition from emerging therapies and generics if biosimilars are approved.
- Potential regulatory restrictions on off-label use.
- Pricing pressures from PBMs and insurers.
Price Projection Outlook
Current Pricing
- List Price: ~$13,000/month per 100 mg tablet pack (based on Nov 2022 data).
- Average Wholesale Price (AWP): roughly $11,500/month.
- Net Price (after rebates/discounts): estimated at 20-30% lower of list price.
Short-term Trends (Next 1-2 Years)
- Stable pricing due to high efficacy and limited biosimilar competition.
- Price adjustments driven by formulary negotiations, with discounts potentially reaching 15-20%.
- Introduction of combination protocols (e.g., venetoclax + obinutuzumab) may impact unit costs but support higher reimbursement values.
Mid-term (3-5 Years)
- Patent expiration anticipated around 2026, opening potential for biosimilar المنافسة.
- Biosimilar entry expected to reduce prices by 20-30%, contingent on FDA approval and market uptake.
- Price reductions in 2028 could bring the unit cost to approximately $9,100–$10,400 per month based on biosimilar competition and market dynamics.
Long-term (5+ Years)
- Biosimilar market stabilization may lead to sustained price reductions.
- Price levels are projected to decline to roughly $7,500–$8,000 per month if multiple biosimilars enter.
- Consideration of value-based pricing models could influence future prices, with discounts tied to clinical outcomes.
Market Value and Revenue Projections
| Year |
Estimated U.S. Market Volume (Units) |
Projected Revenue (USD) |
Assumptions |
| 2023 |
330,000 packs |
$4.3 billion |
10% volume growth from 2022 |
| 2024 |
360,000 packs |
$4.7 billion |
Price maintained, volume increases |
| 2025 |
400,000 packs |
$4.8 billion |
Slight volume increase, prices stable |
| 2026 |
440,000 packs |
$4.2 billion |
Patent expiry, biosimilar entry begins |
| 2027 |
530,000 packs |
$4.2 billion |
Biosimilar market presence increases |
| 2028+ |
550,000 packs |
~$4.4 billion |
Price reductions, stable demand |
Regulatory & Policy Factors
- FDA approval pathways for biosimilars are well-established, with potential biosimilar launches starting in 2026.
- CMS and private insurers are likely to push for price negotiations and step therapy for monoclonal antibodies.
- Price transparency initiatives could influence pricing strategies, possibly leading to more aggressive discounts.
Summary
NDC 64380-0173 (venetoclax) is positioned as a dominant therapy in hematologic oncology, with current sales surpassing $4 billion annually in the U.S. Market growth depends on expanding indications and clinical adoption. Prices are expected to remain stable short-term with potential declines of 20-30% following biosimilar entry around 2026.
Key Takeaways
- Market saturation is imminent as patent expiration approaches.
- Prices are forecasted to decline moderately in the mid-term due to biosimilar competition.
- Volume growth will depend on indication expansion and clinical guideline updates.
- Competitive landscape includes large biotech and pharma with significant sales margins.
- Reimbursement reforms can impact net revenue trajectories.
FAQs
1. When will biosimilars for venetoclax enter the market?
Biosimilar applications are progressing, with FDA approval likely around 2026, aligned with patent expiration.
2. How will biosimilar entry affect prices?
Prices could decrease by 20-30%, depending on biosimilar market competition and payer negotiations.
3. What are the primary drivers for market expansion?
Indication expansion, combination therapies, and broader reimbursement coverage.
4. What are the risks to revenue projections?
Patent litigation delays, regulatory hurdles for biosimilars, and payer resistance to price reductions.
5. How does venetoclax compare in market share to competitors?
Venetoclax holds a significant share in targeted hematologic cancer therapies, competing closely with ibrutinib and obinutuzumab.
References
[1] IQVIA. (2022). United States Prescription Drug Sales Data.
[2] EvaluatePharma. (2022). Global Oncology Market Review.
[3] FDA. (2022). Biologics Price Competition and Innovation Act.
[4] CMS. (2022). Drug Price Negotiation Policy Updates.
