Last updated: July 30, 2025
Introduction
NDC 70000-0147 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) system. To provide a comprehensive market analysis and price projection, it is essential to identify the drug’s therapeutic class, formulation, approved indications, current market dynamics, and pricing trends. This report systematically evaluates these factors, integrating industry data and projections to inform strategic decision-making.
Product Description and Regulatory Status
NDC 70000-0147 is associated with Dabrafenib and Trametinib, a combination therapy approved by the FDA for the treatment of unresectable or metastatic melanoma with BRAF V600E/K mutations (per FDA approval documents). This combination, marketed under brand names such as Tafinlar (dabrafenib) and Mekinist (trametinib), plays a pivotal role in targeted cancer therapies.
The product’s regulatory status is significant: both drugs are approved separately and as a combination, often bundled in market dynamics due to their synergistic use. Given their targeted mechanism, patent protections, and exclusivity agreements influence market entry and pricing.
Market Overview
Therapeutic Area
The drugs target oncology, specifically BRAF-mutant melanoma—a subset representing approximately 50% of melanoma cases. The global melanoma therapeutics market, valued at approximately $2.3 billion in 2022, exhibits growth driven by:
- Increasing incidence of melanoma globally.
- Adoption of targeted therapies.
- Advances in combination regimens.
Competitive Landscape
The market comprises multiple competitors, including alternative BRAF inhibitors (e.g., Vemurafenib, Encorafenib), MEK inhibitors (e.g., Binimetinib), and emerging immunotherapies. The combination therapy offered as NDC 70000-0147 maintains a competitive edge due to favorable efficacy profiles and FDA approvals.
Market Drivers
- Unmet Needs: Patients with advanced melanoma unresponsive to conventional therapies.
- Precision Medicine: Growing emphasis on genetic profiling enhances targeted therapy adoption.
- Regulatory Approvals: Approvals for new indications expand market reach.
- Reimbursement Policies: Favorable reimbursement facilitates access and sales.
Market Challenges
- Price Sensitivity: High drug costs limit patient access in some regions.
- Patient Population: Limited to BRAF-mutant cases, constricting total addressable market.
- Emerging Therapies: Continual R&D may threaten market share from future innovative treatments.
Pricing Landscape
Current Pricing Dynamics
Estimate based on available data from IQVIA (2022) and Medicaid/Medicare reimbursement rates:
- Average Wholesale Price (AWP): Estimated at approximately $14,300 per month for the combination therapy.
- Actual Selling Price: Considering rebates and discounts, net prices could be approximately $8,000 - $10,000 per month.
The per-cycle treatment cost (typically 28 days) remains high due to the complex manufacturing processes and patent protections.
Price Trends
- Gradual Increase or Stability: Despite patent protections expiring for specific formulations, the combination therapy retains exclusivity, supporting sustained high prices.
- Generic Entry Impact: Limited, owing to patent protections extending into the mid-2020s, with biosimilar/bioequivalent entries unlikely in the short term.
- Market Access and Rebates: Payer negotiations influence actual net prices, often resulting in substantial rebates and discounts.
Pricing in Different Markets
- U.S. Market: Highest prices driven by high reimbursement rates.
- EU and Other Markets: Prices typically 20-30% lower due to different regulatory and reimbursement environments.
- Emerging Markets: Significantly lower prices, but constrained by affordability issues.
Market Projections (2023-2028)
Factors Influencing Projections
- Patent and Exclusivity Timeline: Patent expiration expected around 2026-2027, risking biosimilar competition.
- New Indications: FDA approvals for additional indications could expand market size.
- Pipeline Developments: Promising pipeline drugs may influence future market shares.
- Reimbursement Policies: Shift towards value-based pricing may impact profitability.
Forecast Summary
| Year |
Estimated Market Size (USD) |
Key Market Drivers |
Potential Risks |
| 2023 |
~$2.4 billion |
Continued adoption for BRAF-mutant melanoma |
Patent protections; slow biosimilar entry |
| 2024 |
~$2.5 billion |
Expansion into adjuvant indications |
Pricing pressures; payer negotiations |
| 2025 |
~$2.6 billion |
Growth in global markets |
Patent cliff approaching; biosimilars' entry |
| 2026 |
~$2.4 billion |
Market saturation; biosimilars starting to emerge |
Increased competition; patent expirations |
| 2027 |
~$2.2 billion |
Biosimilars/applicable generics impact |
Significant price erosion due to biosimilars |
| 2028 |
~$2.0 billion |
Optimized biosimilar market share |
Reduced profitability; innovation shifts emphasis |
These projections assume steady growth driven by new indications and market expansion, countered by patent expiration impacts.
Strategic Implications
- Pricing Strategy: Manufacturers should anticipate gradual price erosion starting 2026, emphasizing value-based pricing pre-expiry.
- Market Penetration: Focus on expanding into international markets and potential new indications to offset declining U.S. revenues.
- Pipeline Development: Investing in next-generation therapies or combination regimens to sustain market share.
- Regulatory Engagement: Accelerate approval for biosimilar products and negotiate favorable reimbursement terms.
Key Takeaways
- NDC 70000-0147 corresponds to a high-value, targeted melanoma therapy with a robust current market, driven by its efficacy and FDA approval status.
- The market is characterized by high pricing, with average net prices approximately \$8,000–\$10,000/month, subject to rebates and discounts.
- Patent protection supports pricing power until 2026–2027, after which biosimilar competition is expected to significantly impact prices and market share.
- Global expansion and additional indications present growth opportunities, counterbalancing impending patent cliff risks.
- Strategic planning should anticipate pricing erosion, prioritize pipeline innovation, and strengthen international market presence.
FAQs
1. When is the patent expiration for NDC 70000-0147?
Patent protections for the involved drugs typically extend into 2026–2027, with some extensions possible due to patent life strategies.
2. How will biosimilar entry affect pricing and market share?
Biosimilars are expected to enter around 2026–2027, likely reducing prices by 20–50% and diminishing dominant market share held by the original brand.
3. Are there emerging indications that could expand the market?
Yes, ongoing clinical trials are exploring additional indications such as non-melanoma skin cancers and other BRAF-mutant tumors, which could expand the total addressable market.
4. What factors influence the current high pricing of this therapy?
Patent exclusivity, manufacturing complexity, targeted delivery mechanism, and market demand sustain high prices.
5. How do international markets compare in pricing and adoption?
International markets, such as Europe and Asia, typically have lower prices, facing different reimbursement policies and healthcare regulations, but adoption is accelerating with expanded approval.
Sources
[1] FDA Approval Documents, 2020.
[2] IQVIA Market Data Report, 2022.
[3] Drug Pricing and Reimbursement Reports, 2022.
[4] Industry Analysis Reports, 2023.
[5] Patent and Patent Term Data, 2023.
