Last updated: February 20, 2026
What is NDC 83324-0009?
NDC 83324-0009 is the National Drug Code for Dabrafenib Capsules, a targeted therapy used primarily to treat BRAF-mutant melanoma and non-small cell lung cancer. Produced by GlaxoSmithKline, it is marketed under the brand name Tafinlar.
Market Size and Penetration
Current Market Demand
- Global Market Value: Estimated at $1.5 billion in 2022, with projections reaching approximately $2.2 billion by 2028 (IQVIA).
- Indications: Approved for BRAF V600E/K-mutant melanoma, non-small cell lung cancer, and other solid tumors, with expanding indications.
- Patient Population: Approximately 55,000 new cases of melanoma annually in the U.S., with a substantial subset carrying BRAF mutations (~50%).
Competitive Landscape
- Main competitors include Vemurafenib (Zelboraf) and Encorafenib (Braftovi).
- Combination therapies, such as Dabrafenib plus Trametinib, dominate treatment protocols, influencing sales and market share.
Market Penetration
- Estimated to hold 60% of the BRAF-mutant melanoma treatment market.
- Use is increasing in non-melanoma indications, supporting growth.
Price Trends and Projections
Current Pricing Overview
- Average Wholesale Price (AWP): Approximately $7,500 per 30-day supply.
- List Price Variability: Prices fluctuate based on negotiated discounts, insurance coverage, and geographic location.
Historical Price Trends
- Prices increased steadily from $6,000 to $7,500 since FDA approval in 2018.
- No significant recent reductions, despite generic competition not yet available.
Projected Price Trends (2023–2028)
| Year |
Estimated Price (per 30-day supply) |
Notes |
| 2023 |
$7,500 |
Stable, with no major price changes |
| 2024 |
$7,600 |
Minor increase predicted |
| 2025 |
$7,650 |
Cost inflation adjustments |
| 2026 |
$7,700 |
Slight increase expected |
| 2027 |
$7,750 |
Inflation and demand pressures |
| 2028 |
$7,800 |
Market maturity, no price cuts |
Factors Influencing Price Trajectory
- Generics: No generic versions available yet; patent protection extends until 2027.
- Market Competition: Increased use of combination therapies may stabilize or slightly decrease unit demand, exerting upward pressure on unit prices.
- Regulatory Changes: Potential discounts from expanded insurance coverage and negotiations could flatten or limit price increases.
- Manufacturing Costs: Slight increases will align with inflation.
Revenue Implications
- With stable demand and incremental price increases, revenue growth will primarily reflect sales volume.
- Discounting and reimbursement negotiations could reduce effective revenue growth rate.
Key Risks and Opportunities
Risks:
- Patent expiry in 2027 could lead to generic competition, reducing prices sharply.
- Emergence of alternative therapies, especially those with favorable safety profiles or oral administration, could displace Dabrafenib.
Opportunities:
- Expansion into new indications, such as brain metastases, can boost sales volume.
- Combination therapy approvals can increase treatment uptake.
Summary
NDC 83324-0009 (Dabrafenib) shows a mature but stable market with steady price increases predicted through 2028. The absence of generics until 2027 maintains price stability, but expiration of patent protection may significantly impact pricing and market share thereafter. Growth will depend on indication expansion, market adoption, and competitive dynamics among targeted therapies.
Key Takeaways
- The U.S. market for Dabrafenib is valued at roughly $900 million annually, with growth driven by new indications.
- Current prices hover around $7,500 per month, with minor increases expected through 2028.
- Patent expiration in 2027 could introduce generic competition, impacting prices and revenues.
- Competition from combination regimens and alternative targeted therapies remains a key factor.
- Market expansion into central nervous system indications offers revenue growth potential.
FAQs
1. When will generic Dabrafenib enter the market?
Generics are not expected until patent expiry, anticipated in 2027.
2. How does combination therapy affect Dabrafenib pricing?
Combination regimens, like Dabrafenib plus Trametinib, tend to command higher overall prices, but may consolidate market share and influence individual drug prices.
3. Are new indications impacting market size?
Yes. Expanded use in brain metastases and other solid tumors increases demand, supporting sales growth.
4. What forms of pricing discounts are typical?
Insurance negotiations, rebates, and patient assistance programs reduce effective prices below the AWP.
5. How vulnerable is the market to regulatory changes?
Regulatory approvals for new indications and price control policies could alter market dynamics, but currently, no significant changes are imminent.
Sources
- IQVIA. (2023). Pharmaceutical Market Data.
- FDA. (2018). Approval of Tafinlar for Melanoma.
- EvaluatePharma. (2022). World Market Forecasts.
- U.S. Patent and Trademark Office. (2023). Patent Expiry Data.
