Last updated: February 23, 2026
What is NDC 00143-9465?
NDC 00143-9465 corresponds to Vemurafenib, marketed under the brand name Zelboraf. It is a targeted therapy used primarily for melanoma with BRAF V600E or V600K mutations.
Market Overview
FDA Approval and Indications
Vemurafenib received FDA approval in 2011 for late-stage melanoma with BRAF V600E mutation. It expanded its indications to include BRAF V600K mutations in 2014. The drug is now indicated for adult patients.
Current Market Size
Estimated global sales of Vemurafenib reached approximately $540 million in 2022. Major markets include the U.S., EU, and Japan.
Competitive Landscape
Primary competitors include:
- Dabrafenib (Tafinlar): Approved since 2013, often used in combination with trametinib.
- Encorafenib (Braftovi): Approved in 2018 for BRAF-mutant melanoma.
Combination therapies are increasingly standard, which impacts sales of monotherapies.
Market Drivers
- Rising melanoma incidence globally.
- Increasing adoption of personalized medicine.
- Expansion into combination regimens.
Market Challenges
- Patent expirations approaching in 2027.
- Entry of biosimilars and generics.
- Competition from combination therapies offering improved efficacy.
Price Trends and Projections
Historical Pricing Data
- The average wholesale price (AWP) for a 240 mg Vemurafenib tablet was approximately $115 in 2020.
- Monthly treatment costs ranged between $8,500 to $10,000 per patient, depending on dosing.
Price Evolution
From 2010 to 2022, the retail price per tablet increased at a compound annual growth rate (CAGR) of approximately 3%. Factors influencing this include inflation in drug development costs and market demand.
Projected Price Trends (2023-2027)
- Expectation of price stabilization or slight decrease due to biosimilar entry in 2027.
- Forecasted average retail price per tablet to remain in the $110-$120 range until biosimilar competition intensifies.
- Monthly treatment costs projected to decline by 10-15% over the next three years if biosimilars capture significant market share.
Impact of Biosimilars
- Approval of biosimilars could lower retail prices by 20%-30%.
- Insurance coverage and pharmacy benefit management (PBM) strategies will influence actual patient costs.
- Price reduction timeline aligns with biosimilar market entry, expected around 2027.
Revenue Projections (2023-2027)
| Year |
Estimated Global Sales |
Key Growth Drivers |
Impact of Competition |
| 2023 |
$520 million |
Stable demand, limited biosimilar impact |
Slight price pressure |
| 2024 |
$510 million |
Market saturation, new combination therapies |
Price stabilization, biosimilar influence begins |
| 2025 |
$500 million |
Slight revenue decline, biosimilar competition intensifies |
Decrease in premium pricing |
| 2026 |
$480 million |
Biosimilars gain market share |
More aggressive price reductions |
| 2027 |
$430 million |
Increased biosimilar competition, patent expiry |
Significant price decrease expected |
Strategic Considerations for Stakeholders
- Pharmaceutical Developers: Focus on biosimilar development, patent extension strategies.
- Payors and Providers: Monitor biosimilar entry, negotiate pricing, prepare for formulary adjustments.
- Investors: Evaluate pipeline diversification, patent life, and emerging competitors.
Key Takeaways
- NDC 00143-9465 (Vemurafenib) remains a significant melanoma treatment, with global sales around $540 million in 2022.
- Market growth is constrained by increasing competition, especially from combination therapies.
- Price per tablet has seen modest increases historically but is expected to stabilize or decline slightly due to biosimilar entry.
- Biosimilar market entry around 2027 could reduce revenues by up to 30%, influencing overall market dynamics.
- Stakeholders should prioritize patent strategies and consider the impact of biosimilar competition on future pricing and revenue.
5 FAQs
1. What is the primary use of NDC 00143-9465?
It treats BRAF V600E- or V600K-mutant melanoma, used as a monotherapy or part of combination regimens.
2. How is the market for Vemurafenib expected to evolve?
Sales are likely to decline gradually due to biosimilar competition, with a notable drop projected after 2027.
3. What factors influence Vemurafenib pricing?
Market competition, patent protection, biosimilar approval, and healthcare payer negotiations.
4. Are there any approved biosimilars?
No biosimilars are approved as of 2023, but development is underway, targeting patent expiry in 2027.
5. How do combination therapies impact Vemurafenib sales?
They can substitute monotherapy, potentially reducing Vemurafenib's market share and sales over time.
References
- Food and Drug Administration. (2011). FDA approves Vemurafenib for advanced melanoma.
- IQVIA. (2022). Global Oncology Market Data.
- EvaluatePharma. (2022). Sales and price trends for melanoma therapies.
- U.S. Patent and Trademark Office. (2023). Patent filings and expiry dates for BRAF inhibitors.
- Pharmaceutical Research and Manufacturers of America. (2023). Biosimilar development pipeline.
