Last updated: March 10, 2026
What is NDC 00904-6329?
NDC 00904-6329 corresponds to Braftovi (Encorafenib) and Mektovi (Binimetinib) combination therapy, manufactured by Array BioPharma (now part of Pfizer). It is approved for the treatment of BRAF-mutant metastatic melanoma and other BRAF V600-mutant cancers.
Market Overview
Current Market Landscape
- Indication: BRAF V600-mutant melanoma, metastatic colorectal cancer, and other solid tumors.
- Market Size (2022): Estimated global sales of BRAF and MEK inhibitor combinations reached approximately $4 billion.
- Key Competitors:
- Zelboraf (Vemurafenib) – Roche
- Tafinlar (Dabrafenib) – Novartis
- Cotellic (Cobimetinib) – Genentech (partnered with Zelboraf)
- Mekinist (Trametinib) – Novartis
Sales Drivers
- Increasing adoption for BRAF mutation-positive indications.
- Expanding use in combination regimens for colorectal and lung cancers.
- Rising diagnosis rates of BRAF-mutant tumors.
Market Dynamics
- Competition: Multiple options with varying efficacy profiles.
- Pricing Pressure: From biosimilars and cost-containment policies.
- Regulatory approvals: Additional indications may expand market size.
Price Data
Current Pricing (US Market, Approximate at Launch)
| Drug Name |
Dosage Form |
Wholesale Acquisition Cost (WAC) |
Estimated Patient Cost (per month) |
| Braftovi (Enc. + Binimetinib) |
45 mg Enc. + 15 mg Binimetinib capsules |
$18,000 for a 30-day supply |
$18,000–$20,000 |
Note: Prices vary based on discounts, insurance coverage, and pharmacy benefit management negotiations.
Historical Price Trends
- Initial launch prices for targeted therapies typically range between $10,000–$20,000 per month.
- Prices have stabilized but faced pressure from policies favoring biosimilars and generics.
Price Projections (Next 5 Years)
Assumptions
- Continued approval for additional indications such as colorectal and lung cancers.
- Incremental market penetration driven by clinical trial outcomes.
- No major price cuts due to insurance/coverage shifts.
Projected Market Size
| Year |
Projected Global Sales (USD) |
Growth Rate |
Comments |
| 2023 |
$1.5 billion |
- |
Post-launch stabilization |
| 2024 |
$1.8 billion |
+20% |
Expanded indications and increased adoption |
| 2025 |
$2.2 billion |
+22% |
Entry into new markets and stronger clinical data |
| 2026 |
$2.6 billion |
+18% |
Higher market penetration |
| 2027 |
$3.0 billion |
+15% |
Broader usage and price adjustments |
Pricing Outlook
- Stable list prices expected around $18,000–$20,000 per month.
- Potential discounts averaging 10–15% driven by negotiations and formulary inclusion.
- Biosimilar competition unlikely before 2028 due to patent protections and trial exclusivities.
Regulatory and Policy Impact
- Pricing regulations in markets like the US and the EU may influence pricing strategies.
- Price caps for oncology drugs could impact margins.
- Policies favoring biosimilars will pressure prices from 2028 onward.
Key Market Risks
- Emergence of new therapies with superior efficacy could reduce market share.
- Patent litigations or challenges could delay biosimilar entries.
- Changes in healthcare policies impacting drug reimbursement.
Strategic Considerations
- Market position hinges on clinical differentiation and indication breadth.
- Pricing strategies should align with competitive landscape and payer expectations.
- Clinical pipeline expansion could sustain long-term revenue growth.
Key Takeaways
- NDC 00904-6329 (Braftovi/Mektovi) operates in a multi-billion-dollar market with expanding indications.
- Current list prices remain high at $18,000–$20,000 per month, with stable projections.
- Market growth is driven by increased adoption in multiple cancer types and new approvals.
- Price pressures are expected from biosimilar competition, regulatory policies, and value-based care initiatives.
- Strategic positioning relies on demonstrating clinical superiority and navigating reimbursement frameworks.
FAQs
1. What are the primary indications for NDC 00904-6329?
It is primarily approved for BRAF V600-mutant metastatic melanoma, with potential expansion to colorectal and lung cancers.
2. How does the price of NDC 00904-6329 compare to competitors?
Its list price is comparable to other targeted BRAF/MEK inhibitors, generally around $18,000–$20,000 monthly in the US.
3. What factors could influence future pricing?
New indications, competitive biosimilar entries, changes in healthcare policies, and clinical trial outcomes.
4. What is the projected market size for this therapy in 2025?
Approximately $2.2 billion globally.
5. When are biosimilar versions likely to enter the market?
Likely post-2028, after patent protections expire, depending on legal and regulatory timelines.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2023). Drug Approvals and Indications.
- Evaluate Pharma. (2022). Global Oncology Market Report.
- Medicaid and Medicare policies. (2022). Drug reimbursement trends.
- U.S. Food and Drug Administration. (2022). Patent and Exclusivity Data.
