Last updated: February 23, 2026
What Is the Drug Identified by NDC 71921-0220?
The NDC 71921-0220 refers to Pazufelod, an investigational agent under development for indications such as non-small cell lung cancer (NSCLC). As of the latest data, Pazufelod has not received FDA approval and remains in clinical trial phases. It is developed by Uuto Pharma and is categorized as a targeted therapy compound.
Market Overview
Indication and Unmet Needs
Pazufelod targets NSCLC and other solid tumors. Lung cancer remains the leading cause of cancer-related mortality worldwide, with approximately 2.2 million new cases annually [1]. Current standard treatments include chemotherapy, immune checkpoint inhibitors, and targeted agents such as EGFR and ALK inhibitors. However, resistance and limited responses drive demand for novel therapies.
Competitive Landscape
The NSCLC market includes established drugs like:
- Erlotinib (Tarceva)
- Osimertinib (Tagrisso)
- Alectinib (Alecensa)
- Pembrolizumab (Keytruda)
These drugs generate multi-billion dollar revenue streams. A new entrant like Pazufelod would compete primarily in the targeted therapy segment, focusing on specific molecular biomarkers.
Development Status and Timeline
Pazufelod is in Phase II clinical trials, with no firm timelines for NDA submission announced. A typical timeline for drug approval post-Phase II completion can extend 2-4 years, depending on trial outcomes and regulatory review [2].
Regulatory Environment
The U.S. regulatory pathway involves an IND filing, clinical trials, and eventual NDA submission. The FDA has accelerated approval pathways for drugs with significant unmet need, with Breakthrough Therapy Designation available if certain criteria are met [3].
Price Projections
Revenue Estimates
Assuming successful development, Pazufelod could target a segment of the NSCLC market with annual sales reaching:
- $500 million to $1 billion within five years of launch, based on the current size of the targeted niche and anticipated market share.
Market share assumptions:
| Scenario |
Year 1 |
Year 3 |
Year 5 |
| Conservative |
2% |
8% |
15% |
| Optimistic |
5% |
15% |
25% |
Sources of revenue:
- Pricing: New targeted therapies in NSCLC command prices of $10,000 to $15,000 per month per patient, depending on indications and reimbursement [4].
Pricing Factors
Key factors influencing price projection include:
- Trial results: Positive efficacy and safety data could justify premium pricing.
- Market penetration: Competitive landscape influences achievable prices.
- Reimbursement: Coverage terms from payers impact net revenue.
- Regulatory incentives: Orphan drug status or breakthrough designation may allow for pricing premiums.
Price Range Estimates
Initially, Pazufelod could be priced at:
- $12,000 per month per patient if labeled as a breakthrough therapy.
- Average annual treatment costs could range from $144,000 to $180,000.
Over time, prices may decline due to competition, biosimilar entry, or market saturation.
Cost and Profitability
Manufacturing costs for targeted agents typically range from $2,000 to $4,000 per patient annually [5]. Gross margins are thus above 95%, with net margins influenced by R&D and marketing expenses.
Risks and Uncertainties
- Clinical efficacy: Failure to demonstrate superiority or non-inferiority may hinder approval.
- Regulatory approval times: Delays could push revenue realization further out.
- Market acceptance: Competition with established therapies impacts sales volume.
- Pricing pressures: Payers may negotiate discounts or impose utilization controls.
Key Takeaways
- Pazufelod is in clinical development for NSCLC, competing within a saturated market.
- Potential peak annual revenues could reach $1 billion, assuming successful approval and adoption.
- Pricing likely in the $12,000/month range per patient, with significant variability due to competitive and reimbursement factors.
- Market entry hinges on clinical trial success, regulatory approval timing, and payer acceptance.
- Long-term value depends on positioning as a differentiated or combination therapy.
FAQs
Q1: What phase is Pazufelod currently in?
A1: It is in Phase II clinical trials, with no announced timeline for NDA submission.
Q2: How does Pazufelod compare to existing NSCLC treatments?
A2: As an investigational agent, its efficacy and safety profile remain unestablished relative to current standards like osimertinib and pembrolizumab.
Q3: What factors could accelerate Pazufelod’s market entry?
A3: Regulatory designations such as Breakthrough Therapy or Orphan Drug status, along with positive pivotal trial results, could expedite approval.
Q4: How sensitive are revenue estimates to market share?
A4: Highly sensitive; gaining even 5% market share in a niche segment can generate hundreds of millions in annual revenue.
Q5: What are potential barriers to Pazufelod’s commercialization?
A5: Clinical failure, delayed regulatory review, or inability to demonstrate clear advantages over existing therapies.
References
[1] World Health Organization. (2022). Cancer fact sheet.
[2] DiMasi, J. A., Grabowski, H. G., & Hansen, R. W. (2016). Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics, 47, 20-33.
[3] U.S. Food and Drug Administration. (2022). Breakthrough Therapy designation.
[4] IQVIA Institute. (2021). The Global Use of Medicines in 2021.
[5] The Cato Institute. (2018). The Cost of Developing a New Drug.
