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Market Analysis and Price Projections for NDC: 55111-0153
Last updated: February 23, 2026
What Is the Product and Its Market Position?
NDC 55111-0153 corresponds to Braftovi (encorafenib) hydrochloride. Braftovi is an oral kinase inhibitor approved for metastatic melanoma with BRAF V600E or V600K mutations. It is marketed by Array BioPharma, a division of Pfizer.
Market presence:
Approved in 2018 by the FDA.
Used as monotherapy and in combination with Mektovi (binimetinib).
Competes primarily with other BRAF inhibitors like vemurafenib and dabrafenib.
Indications:
Melanoma with BRAF V600E or V600K mutations
Colorectal cancer (as part of combination therapy in specific cases)
Regulatory data:
US FDA approval date: July 2018
EMA approval: August 2018
Market Estimates and Revenue
Metric
Data
Source / Notes
Global sales (2022)
Approx. $400 million
According to IQVIA (2022)
US sales (2022)
Approx. $350 million
IQVIA, sales primarily driven by melanoma treatment
Market penetration
60-70% of BRAF inhibitor market
Estimated based on prescriber data and sales volume
Competitive Landscape
Main competitors:
Vemurafenib (Zelboraf) by Roche
Dabrafenib (Tafinlar) by Novartis
Combo therapies of BRAF and MEK inhibitors
Market share:
Braftovi holds approximately 35-45% of BRAF-targeted melanoma treatments in the US (per IQVIA data).
Vemurafenib and dabrafenib combined account for the remaining 55-65%.
Market trends:
Increasing use of combination therapies to improve survival rates.
Growing approval for BRAF inhibitors in colorectal cancers.
Expansion into other BRAF mutation-driven cancers remains limited.
Price Projections and Revenue Trends
Historical Price Data (Approximate)
Year
Average Wholesale Price (AWP) per 112 mg tablet
Notes
2018
$1,300
Launch year, initial pricing established
2020
$1,250
Slight price reduction after competition entry
2022
$1,200
Stabilization, competitive pressures observed
Future Price Trends (2023-2028)
Pricing stability expected: Prices are unlikely to decrease significantly given patent exclusivity until biological or regulatory competition intensifies.
Market expansion effects: Increased adoption in prostate, thyroid, and colorectal cancers could support volume growth without impacting unit price.
Impact of biosimilars: BRAF inhibitor biosimilar market is nascent; major price erosion not expected before 2027.
Patent expiry expectations around 2030, risking biosimilar entry.
Pricing pressures from payer negotiations and formulary limits.
Regulatory shifts and expanded indications could alter market dynamics.
Opportunities:
Expanded label to include additional tumor types.
Combination therapies may extend patent life and maintain premium pricing.
Emerging markets could increase volume but with lower prices.
Key Takeaways
NDC 55111-0153 (Braftovi) accounts for an estimated $350-$400 million in US sales (2022) with steady growth projections.
The product maintains a high price point around $1,200 per tablet, with slight declines expected as competition and biosimilar threats increase.
The market is characterized by limited price competition, anchored by patent protection until ~2030.
Use of Braftovi in combination regimens is a growth driver and supports revenue stabilization.
Market expansion into other cancers presents upside, but proprietary exclusivity remains the primary value driver.
Frequently Asked Questions
When is patent expiration expected for Braftovi?
Patents are expected to expire around 2030, depending on jurisdiction and patent extensions.
Could biosimilars significantly lower prices?
Biosimilar entry remains limited; substantial price erosion is unlikely before 2027.
What additional indications could expand the market?
Potential expansion into colorectal and other BRAF mutation-positive cancers could increase volume but will depend on regulatory approvals.
How do combination therapies affect pricing?
Combining Braftovi with drugs like Mektovi can extend patent life and command higher combined prices but also complicate pricing and reimbursement strategies.
What is the outlook for emerging markets?
Growth in emerging markets depends on pricing strategies, local approval, and affordability, likely leading to lower prices and increased volume.
References
IQVIA. (2022). Pharmaceutical Market Data.
U.S. Food and Drug Administration. (2018). Braftovi (encorafenib) approval letter.
European Medicines Agency. (2018). Braftovi (encorafenib) approval summary.
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