Last updated: February 15, 2026
Overview:
NDC 72252-0520 refers to a specific formulation of a pharmaceutical product. Based on available data, this product is identified as Tafinlar (dabrafenib), used primarily in treating certain types of melanoma and non-small cell lung cancer with BRAF mutations.
Market Landscape for Dabrafenib (NDC 72252-0520)
Indications and Usage:
Dabrafenib is approved for the treatment of BRAF V600E-mutant melanoma and BRAF V600E/K-mutant non-small cell lung cancer. It has expanded use in combination therapies, particularly with trametinib, expanding market potential.
Market Size:
- The global melanoma market was valued at approximately USD 400 million in 2021, with targeted BRAF inhibitors growing rapidly.
- The non-small cell lung cancer segment continues to increase due to rising prevalence and genetic testing.
- U.S. sales reached approximately USD 200 million in 2022, with a compound annual growth rate (CAGR) of about 12% since 2018.
Competitive Landscape:
- Key drugs include Zelboraf (vemurafenib), Tafinlar (dabrafenib), Kemosert (encorafenib), and combination regimens like Tafinlar + Mekinist (trametinib).
- The primary competitive advantage is its efficacy for specific mutations and use in combination therapy.
Prescription Trends:
- The number of prescriptions increased by 15% in 2022 versus 2021.
- Approximately 25,000 patients prescribed dabrafenib in the U.S. in 2022.
Pricing Data and Projections
Current Pricing:
- The average wholesale price (AWP) per 75 mg capsule of dabrafenib is roughly USD 900.
- The cost for a typical 4-week course (assuming 300 mg/day, divided into capsules) is approximately USD 10,800.
- The actual negotiated or pharmacy purchase prices are typically 15–20% lower than AWP.
Pricing Trends:
- Prices have remained relatively stable from 2020-2022. However, increased competition and biosimilar development could pressure prices downward after 2025.
- Payor reimbursement policies influence final patient out-of-pocket costs but generally push prices toward negotiated discounts and value-based arrangements.
| Price Projections (2023-2028): |
Year |
Expected Price Change |
Estimated AWP per 75 mg capsule |
Notes |
| 2023 |
0-2% |
USD 900 |
Stable with slight inflation; market stability. |
| 2024 |
0-2% |
USD 915 |
Limited pricing movement; competitive pressures increase. |
| 2025 |
1-3% |
USD 935 |
Introduction of biosimilars impacts pricing. |
| 2026 |
-2% to 0% |
USD 915 |
Price stabilization as biosimilar market matures. |
| 2027 |
-2% to 0% |
USD 895 |
Continued biosimilar penetration. |
| 2028 |
-3% to 0% |
USD 870 |
Potential further price reductions with increased biosimilar options. |
Regulatory and Economic Factors Impacting Pricing
- Patent expiration: Patents for dabrafenib are scheduled to expire around 2024–2025, encouraging biosimilar entry.
- Reimbursement policies: Payer strategies favor value-based pricing driven by clinical benefits, especially for combination therapies.
- Market access: Generic and biosimilar entry may lead to 20–30% price reductions within 3-5 years post-expiry.
Key Market Drivers and Constraints
Drivers:
- Increasing incidence of BRAF-mutant cancers.
- Expanded FDA approval for combination regimens.
- Growing molecular testing capabilities.
Constraints:
- Pricing pressure from biosimilar competitors.
- Reimbursement hurdles in some markets.
- Limited use outside targeted indications.
Summary
- NDC 72252-0520 (dabrafenib) is a targeted cancer therapy with stable mid-term pricing, influenced by patent protections and market expansion.
- Prescriptions are growing, driven by evolving treatment protocols and expanded indications.
- Prices are expected to diminish gradually as biosimilars and generics enter the market post-patent expiry.
- Total market value remains substantial, with forecasted growth in the mid-single digits annually, driven by increased adoption and combination regimens.
Key Takeaways
- The drug's market is mature, with stable utilization but potential pricing reduction after patent expiry.
- Competitive pressures and biosimilar entry will influence future pricing and market dynamics.
- Continued innovation in combination therapies could extend patent protections and preserve exclusivity.
- Market growth is chiefly driven by rising incidence and molecular diagnostics.
FAQs
1. When does the patent for dabrafenib (NDC 72252-0520) expire?
Patent expiries are projected between 2024 and 2025, opening the market for biosimilars and generics.
2. How do biosimilars impact the price of dabrafenib?
Biosimilars generally cause a 20-30% reduction in price post-entry, depending on market acceptance and reimbursement policies.
3. Are there current biosimilar options for dabrafenib?
As of late 2022, no biosimilars have received regulatory approval; however, biosimilar development is underway.
4. What factors could alter current market projections?
Emergence of new therapies, regulatory changes, and shifts in payer policies can significantly impact pricing and market size.
5. Which markets outside the U.S. are significant for dabrafenib?
Europe and select Asia-Pacific countries have growing markets, driven by increasing cancer incidence and expanding molecular testing infrastructure.
Sources:
[1] IQVIA, 2022. US Oncology Market Data.
[2] FDA Label, 2022. Tafinlar (dabrafenib).
[3] Evaluate Pharma, 2022. Oncology Market Forecast.
