Last updated: February 21, 2026
What is NDC 00168-0040?
NDC 00168-0040 is the National Drug Code for Vemurafenib (Zelboraf), a targeted therapy for metastatic melanoma with BRAF V600E mutation. Developed by Genentech (a Roche subsidiary), it was approved by the FDA in 2011. The drug is indicated for unresectable or metastatic melanoma that harbors BRAF V600E mutation. It is available primarily through oncology clinics and specialty pharmacies.
Market Overview
Size and Growth Drivers
The global melanoma treatment market was valued at approximately USD 2.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8% through 2030, driven by increased diagnosis rates, expanded indications, and combination therapy approvals.
Market Segments
- Oncology clinics and hospitals: Primary distribution channels.
- Pharmaceutical distributors: Handle procurement and supply.
- Companion diagnostics: BRAF mutation testing becomes essential for targeted therapy.
Competitive Landscape
Key competitors include:
- Dabrafenib (Tafinlar) by Novartis
- Combination of BRAF and MEK inhibitors (e.g., Vemurafenib + Cobimetinib)
Market share is dominated by Vemurafenib, but competition has increased following the approval of combination regimens.
Current Pricing Landscape
List Price (Wholesale Acquisition Cost, WAC)
- Per 480 mg tablet: Approximate WAC is USD 11,400.
- Monthly treatment (based on typical dosing): Approximately USD 6,900–USD 7,500.
Price Trends
- Since approval, prices have experienced minimal inflation, with slight decreases due to discounts, insurance negotiations, and rebates.
- The trend toward combination therapy (e.g., with Cobimetinib) has not significantly impacted the standalone Vemurafenib pricing but has altered overall melanoma treatment costs.
Reimbursement and Insurance Coverage
- Reimbursement rates vary based on country, insurer policies, and negotiated discounts.
- In the US, average net price (post-rebates) is roughly 65-70% of WAC.
Future Price Projections
Short-Term (1-3 Years)
- Stable pricing expected; no significant price increases due to patent protection until 2025.
- Marginal discounts may occur with increased competition and payer negotiations.
Medium to Long-Term (4-7 Years)
- Patent expiration anticipated around 2025.
- Price reductions of 20-30% likely due to biosimilar and generic entries.
- Introduction of biosimilars could cut costs by approximately 40-50% relative to current WAC.
Factors Influencing Price Dynamics
- Patent expiry and biosimilar entry.
- Regional pricing regulations (EU, US, Asia).
- Adoption of value-based pricing models.
- Approval of combination regimens affecting standalone drug sales volume.
Key Market Trends
- Preference for combination therapy: Vemurafenib is increasingly used in conjunction with MEK inhibitors.
- Diagnostic testing: Growing adoption of BRAF mutation testing improves targeted therapy utilization.
- Biosimilar development: Several biosimilars are in early-stage development, potentially disrupting pricing.
Summary Table: Pricing Projections
| Indicator |
2023 |
2025 (Patent expiry) |
2027 (Post-biosimilar entry) |
| WAC per 480 mg tablet |
USD 11,400 |
USD 11,400 |
USD 6,800 – USD 8,600 |
| Monthly treatment cost |
USD 6,900–USD 7,500 |
Similar |
Similar, adjusted for discounts |
| Estimated price reduction (%) |
N/A |
0-5% |
30-50% |
Key Takeaways
- The U.S. market for Vemurafenib (NDC 00168-0040) is stable, with prices near USD 11,400 per 480 mg tablet.
- Its market is driven by melanoma prevalence, diagnostic testing, and combination therapy trends.
- Patent expiration around 2025 could lead to significant price reductions, especially with biosimilar development.
- Reimbursement rates influence net revenue, with negotiated discounts playing a critical role.
- Competition from combination regimens and emerging biosimilars are primary factors affecting future sales and pricing.
FAQs
Q1: When does the patent for Vemurafenib expire?
A: Patent protection is expected to expire around 2025, opening the market for biosimilar entry.
Q2: How does the price of Vemurafenib compare globally?
A: Prices are highest in the US, averaging USD 11,400 per 480 mg tablet, while lower in Europe and emerging markets due to pricing regulations.
Q3: What impact will biosimilars have on pricing?
A: Biosimilars could reduce prices by 40-50%, depending on regulatory approvals and market acceptance.
Q4: Are there any recent updates on pricing trends?
A: Post-2021 data indicates minimal price change, with focus shifting to biosimilar competition and value-based pricing strategies.
Q5: How is the growth of combination therapies affecting the market?
A: It drives overall treatment costs upward but may diminish standalone Vemurafenib sales volume, impacting pricing and revenue projections.
References
- FDA. (2011). FDA Approval of Vemurafenib. [Online] Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/vemurafenib
- Global Market Insights. (2022). Melanoma Therapeutics Market Size.
- IQVIA. (2022). Healthcare Data & Market Trends.
- Pricing and reimbursement data compiled from major US and European sources, 2022.
- Biosimilar pipeline reports. (2023).
