Last updated: February 13, 2026
Product Identification
NDC 00517-0420 corresponds to Braftovi (encorafenib) in combination with Mektovi (binimetinib). These are oncology drugs indicated primarily for the treatment of BRAF V600E or V600K mutant metastatic melanoma and certain solid tumors.
Market Landscape
1. Indications and Market Penetration
Braftovi and Mektovi hold an FDA approval since 2018 for the treatment of advanced melanoma with BRAF V600E/K mutations. The drugs are positioned within the targeted therapy segment, competing with other BRAF/MEK inhibitor combinations like dabrafenib/trametinib (Tafinlar + Mekinist) and encorafenib/binimetinib's direct competitors.
2. Market Size and Growth Factors
The global melanoma treatment market was valued at approximately $892 million in 2021, projected to grow at a CAGR of 8.5% through 2027, driven by increased diagnosis and approval of targeted therapies.
Key factors influencing this growth include:
- Rising incidence of BRAF-mutant melanoma.
- Expansion into other indications such as colorectal and thyroid cancers.
- Adoption of combination regimens in clinical practice.
3. Market Penetration and Adoption
In 2022-2023, Braftovi/Mektovi captured an estimated 10-15% of the melanoma targeted therapy market, primarily driven by second-line treatment pathways. Adoption is strengthened by favorable efficacy profiles and manageable safety data, although competition remains intense.
Pricing and Reimbursement
1. Wholesale Acquisition Cost (WAC)
The average monthly WAC for Braftovi (encorafenib) is approximately $17,000 (USD), and Mektovi (binimetinib) is around $14,500. Pricing for combination therapy aligns with these figures, totaling approximately $31,500 monthly per patient.
2. Price Trends
Since FDA approval, prices have remained relatively stable. Slight adjustments reflect inflation and manufacturing cost changes. Reimbursement is covered by major payers, with patient access facilitated by assistance programs.
- Comparison with Competitors
- Dabrafenib/trametinib combination costs roughly $16,000 monthly per patient, with similar efficacy.
- Encapsulated pricing for Braftovi plus Mektovi remains a premium, justified by patent protections and unique clinical data.
Regulatory and Patent Landscape
1. Patent Protection and Exclusivity
Patents extend protection until at least 2028, with patent families covering the formulations and dosing strategies. Patent expiry could trigger price competition.
2. Regulatory Status
FDA approved baseline in 2018, with supplemental approvals for additional indications provided in subsequent years. Regulatory exclusivity and ongoing clinical trials may influence future market access and pricing.
Price Projection Scenarios
| Scenario |
Time Frame |
Key Assumptions |
Price Trend |
| Conservative |
2023-2027 |
No patent expirations, stable competition, no market entry of generics |
Stabilizes at $31,500/month |
| Moderate |
2028-2032 |
Patent expiry, entry of generics or biosimilars |
Decline to $20,000-25,000/month or +20-30% if branded remains dominant |
| Aggressive |
2033+ |
Multiple generics approved, biosimilars capture market share |
Prices fall below $10,000/month |
Note: These projections assume standard market dynamics; actual outcomes depend on regulatory changes and competitive responses.
Key Takeaways
- Market share for NDC 00517-0420 products remains primarily within targeted melanoma therapy, with significant growth potential as indications expand.
- Pricing has been stable at approximately $31,500 monthly, with a slight bias towards premium pricing due to patent protections.
- Patent expiries around 2028 could significantly alter the market landscape, leading to potential price declines.
- Competitive pressures from other combination therapies may influence future pricing strategies.
- Market growth is expected, powered by rising incidence rates and improved diagnostic techniques.
FAQs
Q1: What is the primary indication for NDC 00517-0420?
A1: It treats BRAF V600E/K mutant metastatic melanoma in combination with Mektovi.
Q2: How does the pricing of Braftovi/Mektovi compare to competitors?
A2: It is priced higher at approximately $31,500 per month, reflecting patent protections and clinical data; competitors like dabrafenib/trametinib cost around $16,000 monthly.
Q3: What are the key factors influencing future prices?
A3: Patent expiries, generic entry, clinical efficacy, regulatory approvals, and market competition.
Q4: When could significant price reductions occur?
A4: Post-2028, assuming patent expiration leads to generic competition.
Q5: What are the growth prospects for this drug?
A5: Good, contingent on expanding indications, increased adoption, and managing competitive dynamics.
References
[1] Global Market Insights, “Melanoma Treatment Market Size,” 2022.
[2] FDA approvals and labels for encorafenib and binimetinib.
[3] IQVIA, "2023 Pricing and Market Data."
[4] Manufacturer product labeling and pricing disclosures.
