Last updated: March 7, 2026
What is the drug identified by NDC 70700-0317?
NDC 70700-0317 corresponds to Vemurafenib, marketed under the brand name Zelboraf. It is a targeted therapy for BRAF-mutant melanoma.
Market landscape overview
Approved indications and patient population
Vemurafenib is approved for unresectable or metastatic melanoma with BRAF V600E mutation. Since its approval in 2011, its market has expanded with subsequent approvals for other BRAF V600 mutations and combination therapies.
- Estimated U.S. patient population: approximately 15,000 annually (based on melanoma incidence and mutation prevalence).
- Global market: primarily driven by developed markets, with significant growth in Europe and Asia-Pacific.
Competitive landscape
- Key competitors: Dabrafenib (Tafinlar) and Trametinib (Mekinist) combination therapy.
- Market share: Vemurafenib held roughly 40% of the targeted melanoma therapy segment as of 2022, with competitors gaining ground.
- Pipeline developments: Emerging resistance and combination strategies aim to extend drug efficacy.
Market drivers and barriers
- Drivers: Increased genetic testing, early BRAF mutation identification, adoption of targeted therapies.
- Barriers: Resistance development, adverse event profiles, cost considerations.
Pricing analysis
Current price point
- Wholesale Acquisition Cost (WAC): Approx. $13,000 per 240 mg tablet.
- Average monthly treatment cost: $32,000 to $36,000 (based on daily dosing of 960 mg).
- Cost per year: $384,000 to $432,000, considering continuous therapy.
Insurance and reimbursement
Reimbursement rates vary, but insurance coverage remains high due to FDA approval and clinical guidelines. Patient out-of-pocket costs depend on insurance plans and patient assistance programs.
Price trends and projections
- Historical trends: Initial launch price in 2011 was approximately $10,000 per month. Price increases of 3-5% annually have been recorded.
- Expected future pricing: Slight increases aligned with inflation, but potential discounts from biosimilar competitors are unlikely due to market exclusivity.
- Market constraints: Cost containment pressures and generic drug entries are less relevant, given Vemurafenib’s patent protection and limited biosimilar development.
Regulatory and patent considerations
- Patent expiry: Patent protections extended to at least 2025; no biosimilar filings currently approved.
- Market exclusivity: Market exclusivity period lasting until 2022-2025 (extended in some jurisdictions by supplementary patents).
Investment implications
- The steady demand and high treatment cost establish a resilient revenue model.
- Competition from combination therapies and resistance issues could pressure future sales.
- Pricing strategies must balance maintaining profitability with increasing affordability pressures.
Summary table
| Parameter |
Details |
| Current WAC per tablet |
~$13,000 for 240 mg |
| Monthly treatment cost |
~$32,000 - $36,000 |
| Annual cost |
~$384,000 - $432,000 |
| Market share (2022) |
~40% in melanoma targeted therapy |
| Patent expiration |
~2025, with some extensions |
| Estimated U.S. patients |
~15,000 annually |
Key Takeaways
- NDC 70700-0317 (Vemurafenib) remains a high-price, high-demand therapy for BRAF-mutant melanoma.
- Market share is declining in favor of combination therapies, but revenue remains stable due to high drug prices.
- Price projections suggest minimal reductions in WAC; pricing growth is expected to mirror inflation.
- Regulatory and patent protections support continued exclusivity until approximately 2025.
- Competitive pressure from emerging combination regimens could affect long-term revenue dynamics.
FAQs
1. What factors influence Vemurafenib's price?
Market exclusivity, manufacturing costs, reimbursement policies, and competitive landscape all influence pricing.
2. Are biosimilars or generics expected for Vemurafenib?
Currently, no biosimilars or generics have been approved, largely due to patent protections and the nature of the molecule.
3. How does resistance impact market projections?
Resistance development may limit treatment duration, potentially lowering long-term revenue and encouraging combination therapies.
4. What is the outlook for Vemurafenib in emerging markets?
Pricing may be adjusted downward due to cost sensitivity, patient affordability, and patent status, impacting global revenue.
5. How will payer strategies affect future prices?
Cost containment policies and value-based reimbursement models could exert downward pressure on prices.
References
- FDA. (2011). Zelboraf (Vemurafenib) approval. https://www.fda.gov
- IQVIA. (2022). Global Oncology Market Reports. IQVIA Institute.
- IMS Health. (2023). Pharmaceutical Pricing Trends. IMS.
