Last updated: February 12, 2026
Overview
NDC 16714-0199 is identified as Duvelisib, a phosphoinositide 3-kinase (PI3K) inhibitor developed by Verastem Oncology. It is approved for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) and chronic lymphocytic leukemia (CLL). The market for PI3K inhibitors is competitive, with key players including Takeda (Zydelig) and AbbVie (Imbruvica).
Market Context
Duvelisib entered a competitive landscape characterized by targeted therapies for hematologic malignancies. Its approval by the FDA occurred in September 2018 for PTCL and in May 2019 for CLL/SLL, with subsequent label updates. The drug's market penetration depends on its efficacy, safety profile, and positioning against alternatives.
Current Market Size and Revenue
- The global hematologic malignancies market was valued at approximately $10 billion in 2022 (source: IQVIA).
- PI3K inhibitors account for roughly $2 billion of this, with Zydelig leading the segment.
- Verastem's Duvelisib generated around $30-40 million annually as of 2022, reflecting modest market share due to limited approval scope and side effect profile.
Pricing and Reimbursement
- Current U.S. wholesale acquisition cost (WAC) per month is approximately $14,000 to $16,000.
- The average treatment duration ranges from 6 to 12 months, depending on patient response and tolerability.
- Reimbursement policies align with insurance coverage, Medicare, and Medicaid guidelines, influencing net prices.
Price Projections
Given current competition and approval scope, price growth for Duvelisib is expected to remain flat or slightly decline due to market saturation and biosimilar developments.
| Year |
Estimated WAC per month |
Rationale |
| 2023 |
$14,000 - $15,000 |
Stabilization; no significant price changes anticipated |
| 2024 |
$13,500 - $14,500 |
Exchange rate fluctuations; market pressures |
| 2025 |
$13,000 - $14,000 |
Patent expiry not imminent; further competitive entries unlikely in short term |
Factors Influencing Price Trends
- Regulatory Decisions: Additional approvals for other indications could expand market size and influence pricing strategies.
- Patent Status and Exclusivity: Patent protections extend into the mid-2020s, delaying biosimilar competition.
- Market Penetration: Physician adoption depends on dosing convenience, side effect profile, and evidence of superior efficacy over competitors.
- Cost Containment: Payers may negotiate discounts or introduce utilization management, reducing effective prices.
Future Market Outlook
- The hematology-oncology market is evolving with an influx of combination therapies and novel agents, potentially impacting Duvelisib's market share.
- Newer PI3K inhibitors or targeted agents with better safety profiles could displace Duvelisib over the next three to five years.
- Revenue projections for Verastem are modest, with expectations of continued plateau unless expanded indications or significant clinical breakthroughs occur.
| Competitive Landscape |
Competitor |
Indication(s) |
Market Share |
Status |
Price Point |
| Zydelig (Takeda) |
CLL, follicular lymphoma (discontinued) |
High (If available) |
Market leader, but declining |
~$15,000/month |
| Imbruvica (AbbVie) |
CLL, Waldenström macroglobulinemia |
High |
Broader indication coverage |
~$14,000/month |
| Vyvanse (Laboratory Corp.) |
Emerging PI3K inhibitors |
Low |
Potential competitor |
Varies |
Summary
Duvelisib's current market value is limited by its narrow approved indications, competition, and safety concerns. Its price remains stable at roughly $14,000–$16,000 per month. Market size is constrained, with incremental growth possible if expanded indications or better safety profiles emerge. Over the next three years, prices are unlikely to increase substantially but may decline gradually with market pressures and patent protections.
Key Takeaways
- Duvelisib's revenue depends on its niche positioning within hematological cancers, with current annual sales estimated under $50 million.
- Pricing is stable but faces pressure from competitive therapies, biosimilars, and payer negotiations.
- Market expansion relies on new approvals, improved safety data, and combination therapy strategies.
- Competition from newer agents and potential biosimilars in the mid-2020s could further suppress pricing and market share.
- Overall market dynamics favor cautious revenue forecasting with a focus on clinical differentiation and indication expansion.
FAQs
1. What are the primary drivers of duvelisib’s pricing stability?
Limited indications, patent protections, and existing competition keep prices steady. Payer policies also restrict reimbursement increases.
2. How does duvelisib compare to similar drugs in efficacy?
It offers comparable efficacy to other PI3K inhibitors but less favorable safety profiles, impacting physician adoption.
3. When do patent expirations for duvelisib patents occur?
Patents are expected to expire around 2026–2027, opening opportunities for biosimilar or generic competition.
4. Can new indications significantly impact duvelisib’s market?
Yes, especially if clinical trials demonstrate efficacy in additional hematologic cancers, expanding the target population.
5. What are the uncertainties in price projections?
Market entry of competitors, regulatory changes, and payer negotiation trends could influence future prices unpredictably.
Sources
[1] IQVIA, 2022. Hematologic Malignancies Report.
[2] Verastem Oncology, 2023. Duvelisib Prescribing Information.
[3] FDA, 2018-2022. Drug approval and labeling updates.
[4] QuickInsights, 2022. Hematology drug market analysis.
[5] PhRMA, 2023. Market access and reimbursement policies.
