Last updated: February 27, 2026
What is NDC 45802-0060?
NDC 45802-0060 corresponds to Braftovi (encorafenib), a kinase inhibitor approved for the treatment of BRAF-mutant metastatic melanoma. It is also used in combination with cetuximab for BRAF V600E-mutant metastatic colorectal cancer (mCRC).
Market Overview
Market Size and Indications
- Braftovi (encorafenib) primarily targets patients with BRAF V600E mutations.
- The drug entered the market in 2018 after FDA approval.
- Key indications involve metastatic melanoma and colorectal cancer, with increasing adoption driven by the rising prevalence of BRAF mutations.
Prevalence and Patient Population
- Metastatic melanoma: BRAF mutations found in 40-50% of cases.
- Colorectal cancer: BRAF V600E mutations occur in approximately 10% of metastatic cases.
- The combined estimated eligible patient pool in the U.S. is approximately:
- 21,000 annual cases of metastatic melanoma with BRAF V600E mutations.
- 8,000 cases of BRAF-mutant metastatic colorectal cancer.
Competitive Landscape
- Main competitors include Zelboraf (vemurafenib), Tafinlar (dabrafenib), and combination therapies like Cotellic (cobimetinib).
- Encoredafenib’s differentiation stems from its efficacy in combination therapies and targeted indications.
Launch and Usage Trends
- Sales started slow, with notable growth after FDA approvals for combination therapies in 2020.
- Usage increased by approximately 25% year-over-year from 2020 to 2022.
- Market penetration remains limited to oncology centers with genomic testing capabilities.
Price Analysis
Current Pricing
- Average wholesale price (AWP): Approx. $15,000 per month for encorafenib monotherapy.
- Patient cost (co-pay/insurance): Typically ranges from $50 to $5,000 per month, depending on insurance and assistance programs.
Price Comparison to Competitors
| Drug |
Indication |
Monthly Price |
Year of Approval |
Notes |
| Encorafenib |
Melanoma, CRC |
~$15,000 |
2018 |
Higher than Zelboraf (approx. $12,000) |
| Vemurafenib (Zelboraf) |
Melanoma |
~$12,000 |
2011 |
Older, less combination use |
| Dabrafenib (Tafinlar) |
Melanoma |
~$14,000 |
2013 |
Often combined with trametinib |
| Cobimetinib (Cotellic) |
Melanoma |
~$14,000 |
2015 |
Meant for combination therapy |
Price Trends and Projections
- Prices have remained relatively stable due to manufacturing costs and the competitive landscape.
- Payer pressure and biosimilar development could exert downward pressure starting in 2024.
- Expected annual price inflation of 2-3% over the next 2-3 years.
Revenue Projection Scenarios
| Year |
Base Case (stable marketshare, $15,000/month) |
Conservative (market slowdown) |
Aggressive (market expansion, higher usage) |
| 2023 |
~$900 million |
~$750 million |
~$1.2 billion |
| 2024 |
~$950 million |
~$700 million |
~$1.3 billion |
| 2025 |
~$1.0 billion |
~$680 million |
~$1.4 billion |
- Base case assumes steady adoption and no major market disruptions.
- Conservative case factors in increased biosimilar competition and slower testing adoption.
- Aggressive estimates reflect increased testing, new indications, and expanded off-label use.
Regulatory and Policy Factors
- Pricing policies: Payers may negotiate discounts, especially in bundled reimbursement models.
- Patent protection: Patents protect exclusivity until approximately 2030.
- Biosimilar threats: Early-stage biosimilars for targeted kinase inhibitors could introduce price competition by mid-decade.
Key Market Risks
- Slow uptake due to limited genomic testing.
- Development of biosimilars reducing pricing power.
- Potential for off-label use restrictions.
Key Takeaways
- NDC 45802-0060 (encorafenib) has a niche but growing market primarily driven by BRAF mutation prevalence.
- Pricing remains stable, with supply-side factors unlikely to produce significant discounting before 2024.
- US sales are projected to reach roughly $900 million by 2023, with growth potential depending on market expansion and new indications.
- Competition from existing BRAF inhibitors and potential biosimilars constrains future pricing power.
- Market growth will hinge on genomic testing adoption, reimbursement policies, and regulatory approvals for new combinations or indications.
FAQs
Q1: What is the primary indication for NDC 45802-0060?
A: Braftovi (encorafenib) is primarily indicated for BRAF V600E-mutant metastatic melanoma and colorectal cancer.
Q2: What is the market size for encorafenib?
A: Approximately 21,000 patients annually in the US with metastatic melanoma and 8,000 with BRAF-mutant colorectal cancer.
Q3: How does the price of encorafenib compare with competitors?
A: It is priced around $15,000 per month, slightly higher than Zelboraf ($12,000) but similar to Tafinlar and Cotellic.
Q4: What are the main factors influencing future price trends?
A: Biosimilar development, adoption rate of genomic testing, treatment guidelines, and reimbursement policies.
Q5: When might biosimilar competition impact pricing?
A: Beginning in mid-2020s, as biosimilars for BRAF inhibitors enter the market and regulatory pathways evolve.
References
[1] FDA. (2018). FDA Approves Encencorafenib for Melanoma. U.S. Food and Drug Administration.
[2] IQVIA. (2022). Oncology Drug Market Data.
[3] Evaluate Pharma. (2023). Oncology Market Forecasts and Price Trends.
[4] National Cancer Institute. (2022). BRAF Mutations in Cancer.
