Last updated: February 14, 2026
Overview
NDC 51407-0350 is a prescription drug identified as Braftovi (encorafenib) 45 mg capsules manufactured by Array BioPharma, a Roche subsidiary. It is indicated for use in the treatment of certain melanoma and colorectal cancers with BRAF V600E or V600K mutations.
Market Context
The BRAF inhibitor class, including Braftovi, has seen increasing adoption due to expanded indications and the introduction of combination therapies. The drug primarily competes with other targeted therapies such as Zelboraf (vemurafenib) and Tafinlar (dabrafenib). The global oncology market's growth and rising prevalence of BRAF-mutant cancers influence Braftovi's market share.
Market Size and Growth Trends
- Incidence Rates: Melanoma accounts for approximately 1.6% of skin cancers, with roughly 77,000 new cases annually in the U.S. (CDC). Colorectal cancers are the third most common, with about 151,000 diagnoses annually in the U.S. (ACS).
- Treatment Penetration: Braftovi's utilization in approved indications has grown following FDA approvals for combined therapies with Mektovi (binimetinib) in BRAF V600E/K-mutant melanoma and colorectal cancer.
- Market Penetration: As of 2023, Braftovi captures an estimated 25-35% of the targeted BRAF-mutant melanoma segment and approximately 10-15% in colorectal cancer.
Pricing Landscape
- Current List Price: The wholesale acquisition cost (WAC) for Braftovi capsules is approximately $16,500 per 112-count bottle of 45 mg capsules. Based on prescribed dosages, monthly treatment costs range from $16,000 to $20,000.
- Reimbursement: Medicare Part D and commercial payers typically reimburse at levels close to the WAC minus negotiated discounts. Patient out-of-pocket costs vary but are often in the $50-$300 range due to co-pays.
- Comparators: Zelboraf (vemurafenib) has a similar price point (~$17,000/month), while Tafinlar (dabrafenib) runs around $15,000/month.
Price Projections (2023–2028)
| Year |
Estimated Price Range (per month) |
Rationale |
| 2023 |
$16,000 – $20,000 |
Stable, high demand, no imminent patent protections expiration. |
| 2024 |
$15,500 – $19,500 |
Potential discounts due to market competition, increased biosimilar presence. |
| 2025 |
$15,000 – $19,000 |
Closer to patent expiry for some indications; newer combination therapies could impact demand. |
| 2026 |
$14,500 – $18,500 |
Anticipated patent expiration and market entry of biosimilar competitors. |
| 2027 |
$14,000 – $18,000 |
Biosimilar options likely available, pressuring list prices. |
| 2028 |
$13,500 – $17,500 |
Continued biosimilar competition, price erosion becomes significant. |
Factors Influencing Price Trends
- Patent Expiry: The primary patent for encorafenib in the U.S. expires around 2027, opening pathways for biosimilar entry.
- Market Competition: Biosimilars for Braftovi are under development, pressuring pricing post-2026.
- Regulatory and Policy Changes: Increased emphasis on biosimilar adoption, value-based pricing, and national formularies influence pricing strategies.
- Clinical Adoption: Broader utilization due to expanding indications or combination therapies will sustain pricing levels.
Regulatory and Patent Status
- Patents: Patent protections are expected to lapse in 2027 for primary formulations.
- FDA Approvals: Expand to additional indications, such as early-stage melanomas, could extend the marketed life cycle.
- Biosimilars: Development is ongoing, with one biosimilar candidate in Phase 3 trials as of 2022, expected to impact pricing from mid–late 2020s.
Conclusion
Braftovi’s current market price aligns with other targeted therapies in oncology, supported by consistent demand driven by its indications. Price declines are anticipated confidence with patent expiration and biosimilar competition, with a potential reduction of 10-20% over the next five years.
Key Takeaways
- NDC 51407-0350 (Braftovi) is priced at approximately $16,000 to $20,000 per month.
- Market dynamics are shifting toward biosimilar competition, likely reducing prices starting around 2026–2027.
- Indications expand incrementally, supporting sustained revenue through 2024–2025.
- Patent expiration in 2027 sets the stage for significant price erosion.
- Competitive strategies include value-based pricing and expanding combination uses.
FAQs
-
When is patent expiration for encorafenib?
Patent expiration expected around 2027, with some patent protections potentially extending to 2029 due to formulations and method patents.
-
Are biosimilars in development?
Yes, several biosimilar candidates targeting encorafenib are under late-stage clinical trials, with approval prospects from 2025 onward.
-
How does pricing compare with similar therapies?
Enc**orafenib’s list pricing is similar to Zelboraf and Tafinlar, with slight variations depending on dosage and formulation.
-
What are the main factors that could alter price projections?
Introduction of biosimilars, patent litigation, regulatory policy shifts, and market penetration of combination therapies.
-
How is insurance coverage impacting the drug’s pricing?
Reimbursement substantially follows list prices, but patient out-of-pocket costs are mitigated by co-pay assistance programs, which sustain demand.
Sources
[1] CDC. Melanoma statistics.
[2] ACS. Colorectal Cancer Facts & Figures.
[3] FDA. Braftovi approved indications and patent information.
[4] IQVIA. Oncology drug pricing data.
