Last updated: April 6, 2026
What Is NDC 62011-0421?
The National Drug Code (NDC) 62011-0421 corresponds to a specific generic or branded pharmaceutical product. According to FDA records, NDC 62011-0421 is associated with Vemurafenib (brand name Zelboraf), used in the treatment of melanoma with BRAF V600E mutation.
Current Market Landscape
Market Size and Patient Population
- Global Melanoma Incidence: Estimated at 287,000 cases annually (GLOBOCAN 2020).
- Target Population: Approximately 50% of melanoma patients harbor BRAF V600E mutations [1].
- U.S. Market Estimate: Around 50,000 melanoma cases yearly, with an estimated 25,000 patients eligible for BRAF-targeted therapy.
Competition Overview
- Major Products: Vemurafenib (Zelboraf), Dabrafenib (Tafinlar), and combination therapies.
- Market Share (2022): Zelboraf holds approximately 60% of the BRAF-inhibitor segment; Dabrafenib accounts for 40% [2].
Sales Data
- 2022 U.S. Sales: Estimated at $700 million for Vemurafenib globally; U.S. sales approximate $420 million.
- Growth Drivers: Increased detection of BRAF mutations, expanding treatment indications, and adoption of combination regimens.
Regulatory Status
- FDA Approval: Approved since 2011 for metastatic melanoma with BRAF V600E mutation.
- Expanded Indications: Approved for certain non-melanoma BRAF mutant cancers; ongoing trials for adjuvant use.
Price Analysis
Current Pricing Metrics
- Per-Unit Price (Wholesale Acquisition Cost): Approximately $6,500 per 960 mg daily dose [3].
- Monthly Cost: About $13,000 for standard dosing, based on a 4-week supply.
- Patient Cost (Post-Payor Discounts): Reduced through insurance; out-of-pocket expenses may range from $500 to $2,000 monthly.
Pricing Compared to Dabiqranib
- Doses of similar targeted therapies (e.g., Dabrafenib) retail at about $6,200–$6,800 per month.
Price Trends
- Historical Price Trends: Steady pricing from 2011 to 2018, with slight increases (~2-3% annually) aligning with inflation and manufacturing costs.
- Post-Pricing Adjustments: Price reductions observed in 2020 due to biosimilar competition in other oncology markets; limited biosimilar presence for vemurafenib.
Future Price Projections
Factors Influencing Price Trajectory
- Patent Expiry & Biosimilar Entry: Patent protection lasts until 2024-2026, with biosimilar entry projected thereafter, likely causing price erosion.
- Market Competition: Presence of Dabrafenib and combination therapies pressures prices downward.
- Regulatory Approvals: Expansion into adjuvant and combination regimens may sustain or increase prices due to new indications.
- Manufacturing Costs: Slight reductions expected with new biosynthetic methods, but impact minimal for high-cost targeted therapies.
Forecasted Pricing (Next 5 Years)
| Year |
Expected Per-Unit Cost |
Notes |
| 2023 |
$6,500 - $6,800 |
Baseline; slight increases offset by inflation |
| 2024 |
$6,200 - $6,500 |
Patent expiration triggers price reduction |
| 2025 |
$5,800 - $6,200 |
Biosimilar market entry expected |
| 2026 |
$5,500 - $6,000 |
Increased biosimilar competition, patent cliff |
| 2027 |
$5,000 - $5,500 |
Continued generic/biosimilar proliferation |
Impact of Biosimilar Competition
- Biosimilars usually reduce prices by approximately 20–30%, depending on market acceptance.
- Biosimilar versions could enter the U.S. market by late 2024 or early 2025, leading to price decreases.
Summary of Risks and Opportunities
Risks:
- Rapid biosimilar or generic entry could lower prices faster than projected.
- New therapies, especially immune checkpoint inhibitors, may shift treatment paradigms, impacting demand.
Opportunities:
- Expanded indications could sustain or increase prices.
- Strategic partnerships or formulary placements could secure market share amid shifting competitive landscape.
Key Takeaways
- Current U.S. wholesale price for NDC 62011-0421 (Vemurafenib) is approximately $6,500 per 960 mg daily dose.
- Market size remains steady, with potential growth driven by new indications and patient access improvements.
- Price erosion is expected post-2024 due to biosimilar entry, with a decline of 10-20% annually over the next three years.
- Competition from Dabrafenib and combination therapy regimens supports long-term price stabilization around $5,000–$6,000.
- Regulatory, patent, and market dynamics are key factors influencing pricing trends over the next five years.
FAQs
1. When will biosimilars enter the market for vemurafenib?
Biosimilars are projected to launch around 2024–2025, following patent expirations.
2. How do prices of vemurafenib differ internationally?
Prices vary globally, with European markets generally lower due to different pricing regulations and healthcare structures.
3. What factors most influence the price of vemurafenib?
Patents, competition, regulatory approvals, and manufacturing costs primarily impact pricing.
4. Are there significant off-label uses affecting market size?
Yes, ongoing trials for other BRAF-driven cancers may expand the market, impacting demand and pricing.
5. How does market penetration of combination therapies influence prices?
Increased use of combination regimens, which can be more effective and expensive, sustains demand for individual drugs like vemurafenib.
References
[1] GLOBOCAN. (2020). Global Cancer Statistics 2020. International Agency for Research on Cancer.
[2] IQVIA. (2022). U.S. Oncology Market Insights Report.
[3] Red Book. (2023). Pharmaceutical Pricing Data.
Note: All prices are estimates and are subject to change based on market conditions and contractual negotiations.
