Last updated: February 27, 2026
What is NDC 31722-0936?
NDC 31722-0936 corresponds to Venclexta (venetoclax), supplied by AbbVie. It is an oral BCL-2 inhibitor approved for treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, and acute myeloid leukemia (AML) in specific settings.
Market Overview
Patient Population
- CLL: Approximately 168,000 cases in the U.S.
- SLL: Similar incidence as CLL.
- AML: 20,000 new cases annually in the U.S.
Market Drivers
- Increasing adoption due to proven efficacy.
- Expanded indications for AML.
- Growing prevalence of hematologic malignancies.
- Favorable safety profile compared to chemotherapies.
Competitive Landscape
| Drug Name |
Mechanism |
Approvals |
Market Share (Estimate) |
Notable Competitors |
| Venclexta |
BCL-2 inhibitor |
CLL, AML |
60% (incl. in combination) |
Ibrutinib, Acalabrutinib, Gazyva |
| Ibrutinib |
BTK inhibitor |
CLL, WM, MCL |
30% |
- |
| Gazyva |
CD20 antibody |
CLL, follicular lymphoma |
10% |
- |
Revenue Trends
- In 2022, Venclexta generated approximately $2.2 billion globally.
- The U.S. accounts for roughly 70% of sales.
- Growth driven by new indications and combination regimens.
Pricing Analysis
Current Wholesale Acquisition Cost (WAC)
- Venclexta's WAC per 100 mg tablet: ~$1,200.
- Typical dose: 400 mg daily (4 tablets), translating to roughly $4,800/day.
- Monthly treatment cost: approximately $144,000.
Price Trends
- Price adjustments have been minimal in the past three years.
- Favorable reimbursement strategies and patient assistance programs mitigate cost barriers.
Price Competitiveness
Compared to molecular targeted therapies:
| Drug |
Typical Monthly Cost |
Indications |
Approval Year |
| Venclexta |
$144,000 |
CLL, AML |
2016 (CLL), 2019 (AML) |
| Ibrutinib |
$140,000 |
CLL, MCL |
2013 |
| Gazyva |
$125,000 |
CLL |
2014 |
Venclexta's price aligns with competitive standards for targeted oncology treatments.
Market Penetration and Future Projections
Short-term Outlook (Next 2 Years)
- Expected moderate growth (~8%-10%) driven by expanded indications.
- Increased utilization in combination therapies.
Long-term Outlook (5 Year)
- Potential double-digit compound annual growth rate (~12%) as new indications and combinations expand.
- Entry of biosimilars and generics unlikely due to patent protections until at least 2030.
Patent and Regulatory Considerations
- Patent expiry scheduled for 2028.
- Patent protections limit generic competition until then.
Market Challenges and Risks
- Price erosion due to biosimilar entry.
- Regulatory hurdles in expanding indications.
- Competition from emerging therapies (e.g., CAR-T).
Summary Table: Price Projections 2023-2028
| Year |
Estimated WAC per 100 mg tablet |
Monthly Treatment Cost |
Notes |
| 2023 |
$1,200 |
~$144,000 |
Stable pricing |
| 2024 |
$1,200 |
~$144,000 |
No significant change |
| 2025 |
$1,180 |
~$141,600 |
Slight discounting possible |
| 2026 |
$1,160 |
~$139,200 |
Competitive pricing strategies |
| 2027 |
$1,140 |
~$136,800 |
Pre-patent expiry adjustments |
| 2028 |
$1,120 |
~$134,400 |
Possible price reductions pre-expiry |
Key Takeaways
- The current market for Venclexta is characterized by stable high pricing, with revenue growth driven primarily by expanding indications.
- Competition remains limited but is increasing with the potential advent of biosimilars post-2028.
- Price projection indicates minor reductions aligned with patent expiration and market dynamics.
- The drug maintains a strong position in the hematology-oncology niche due to its efficacy and safety profile.
FAQs
Q1: What factors influence the price of NDC 31722-0936?
Market exclusivity, manufacturing costs, reimbursement policies, and competitiveness influence pricing. Patent protections prevent significant price erosion until 2028.
Q2: How does the price of Venclexta compare with competitors?
It is comparable, generally within $125,000–$144,000 monthly, depending on dosing and indication, aligning with other targeted oncology agents.
Q3: What is the impact of biosimilars or generics on the price?
Entry of biosimilars or generics post-2028 is expected to reduce prices significantly, potentially by 30-50% over initial levels.
Q4: What future indications could affect the market?
Ongoing trials for AML and other hematologic malignancies could expand the target population, potentially increasing market size and sales.
Q5: How do reimbursement policies influence the drug's market?
Reimbursement strategies and assistance programs have mitigated access barriers, maintaining high utilization despite high prices.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] FDA. (2019). Venclexta (venetoclax) approval documents.
[3] EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
[4] Centers for Disease Control and Prevention. (2022). Cancer Statistics.
[5] Statista. (2023). Pricing overview of selected oncology drugs.
