Last updated: August 3, 2025
Overview of NDC 51407-0053
NDC (National Drug Code) 51407-0053 corresponds to a specific pharmaceutical product listed in the U.S. Food and Drug Administration's databases. While proprietary details vary, it is imperative to identify its therapeutic class, manufacturer, formulation, and target patient population to conduct an accurate market and pricing analysis.
Based on publicly available data, NDC 51407-0053 refers to Venclexta (venetoclax), a BCL-2 inhibitor approved by the FDA for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and acute myeloid leukemia (AML) [1].
Market Landscape
1. Therapeutic Indication and Market Size
Venclexta has established itself as a frontline therapy for CLL and SLL, with expanding uses for AML, owing to its mechanism of promoting apoptosis in cancer cells [2]. The global hematologic oncology drug market is projected to grow at a CAGR of approximately 8% through 2028, driven by increasing prevalence of hematological malignancies and advancements in targeted therapies [3].
2. Competitive Landscape
Venclexta competes with other targeted agents such as ibrutinib (Imbruvica), obinutuzumab (Gazyva), and newer BCL-2 inhibitors under development. The competitive edge of venetoclax stems from its efficacy in combination regimens and its approval for previously untreated patient populations.
3. Market Penetration and Adoption
Initial market adoption was rapid given the unmet clinical need. As of 2023, Venclexta holds a significant share in hematologic oncology, attributable to its robust clinical trial results and FDA approvals. Usage patterns suggest increasing prescriptions, especially as combination therapies become standard care, pushing further expansion into earlier lines of treatment [4].
Pricing Dynamics
1. Current Price Points
The wholesale acquisition cost (WAC) for Venclexta approximates $13,000 per month for a typical 28-day supply, translating roughly to $156,000 annually [5]. These figures fluctuate based on dosage regimens, patient weight, and negotiated discounts.
2. Reimbursement and Pricing Trends
Medicare and private insurers negotiate rebates and discounts, often reducing net pricing. The increasing trend toward value-based pricing and outcomes-based agreements influences retail and wholesale prices. Notably, pricing strategies also factor in competition and biosimilar markets once biosimilar versions or generics are introduced.
3. Impact of Patent and Exclusivity
Venclexta's patent protections and regulatory exclusivity shield it from generic competition until 2030, supporting premium pricing. However, patent litigations and biosimilar entries could pressure prices over the next decade [6].
Pricing Projections (2023-2030)
1. Short-Term (2023-2025)
Given current market dynamics and patent protection, the drug’s price is expected to remain relatively stable or slightly decrease due to negotiated rebates and formulary placements. Manufacturers may introduce discounts or patient assistance programs to sustain uptake.
2. Mid-Term (2025-2027)
As clinical data further supports expanded indications and combination therapies, demand is projected to increase. Price adjustments may be minimal; however, pushing for value-based contracts could modify effective prices.
3. Long-Term (2028-2030)
The expiration of patent protections and the entry of biosimilars may lead to significant price erosion—potentially 20-40%—aligning with trends observed with similar oncology agents. Regulatory and market factors such as competitive biosimilars or alternative therapies could accelerate this decline.
Key Market Drivers
- Regulatory approvals for additional indications, expanding patient populations.
- Clinical efficacy and safety profiles strengthening prescribing confidence.
- Healthcare policy shifts favoring value-based procurement.
- Development pipeline and potential biosimilar entries influencing pricing strategies.
- Reimbursement policies affecting net pricing and patient affordability.
Risks and Challenges
- Patent litigations or legal challenges could precipitate early generic entry, pressuring prices.
- Market saturation with competing therapies and combination regimens.
- Regulatory restrictions or changes in reimbursement policies.
- Cost containment initiatives by payers reducing allowable prices.
Conclusion
NDC 51407-0053, identified as Venclexta, remains a high-value oncology agent with strong market presence driven by its efficacy. Price stability is expected in the short term, with significant downward pressure anticipated once biosimilar competition materializes. Market expansion through new indications and combination therapies supports current valuations, but long-term pricing will increasingly depend on patent status and competitive dynamics.
Key Takeaways
- Market Position: Venclexta commands premium pricing supported by robust clinical data and patent exclusivity.
- Pricing Trends: Expect stability through 2025, with potential declines post-2028 due to biosimilar competition.
- Growth Drivers: Expansion into new indications, combination regimens, and global markets.
- Risks: Patent challenges and competitive pressure pose risks to sustained pricing.
- Strategic Focus: Stakeholders should monitor patent statuses, clinical pipeline developments, and evolving reimbursement models to optimize market and pricing strategies.
FAQs
Q1: When is the patent for Venclexta expected to expire?
A1: Patent protection is projected to last until approximately 2030, after which biosimilar competition may emerge.
Q2: How does the clinical efficacy of Venclexta influence its market price?
A2: Superior efficacy and safety profiles justify premium pricing; positive trial outcomes support expanding indications and market share.
Q3: What factors could accelerate price reductions for NDC 51407-0053?
A3: Patent expiration, biosimilar approvals, increased competition, and policy shifts toward cost containment.
Q4: How do reimbursement policies impact the net price of Venclexta?
A4: Negotiated rebates, formularies, and outcomes-based agreements significantly reduce net reimbursements from list prices.
Q5: What is the outlook for new formulations or combination therapies involving Venclexta?
A5: They are likely to boost demand but could also influence pricing strategies depending on clinical and economic evaluations.
References
[1] FDA. Venclexta (venetoclax) label. 2019.
[2] National Cancer Institute. Venetoclax overview. 2021.
[3] MarketWatch. Hematologic Oncology Drugs Market Report. 2022.
[4] IQVIA. U.S. Oncology Trends Analysis. 2023.
[5] GoodRx. Venclexta pricing. 2023.
[6] Patent and Trademark Office. Patent expiry data. 2022.
