Last updated: February 16, 2026
Product Identification
NDC 72252-0510 corresponds to a specific drug formulation and package size. Based on available data, this code matches Vemurafenib (Zelboraf), a targeted therapy for melanoma with BRAF V600E mutation. The drug is supplied in a 240 mg, oral tablet format, typically packaged in bottles or blister packs.
Current Market Landscape
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Indications and Approved Uses
Vemurafenib received FDA approval in 2011 for unresectable or metastatic melanoma with BRAF V600E mutation. It is also approved for other BRAF V600E mutation-positive cancers, including hairy cell leukemia (2018). These indications shape the target patient population.
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Market Size and Penetration
- The global melanoma drug market was valued at approximately USD 2.5 billion in 2022, with Vemurafenib representing a significant segment.
- The US accounts for roughly 40% of global sales due to higher incidence rates and healthcare expenditure.
- Estimated annual patient numbers for metastatic melanoma with BRAF V600E mutation in the US range from 20,000 to 25,000.
- Market penetration: Vemurafenib has established itself as a first-line therapy, often used in combination with cobimetinib (Cotellic) or dabrafenib (Tafinlar).
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Competitive Landscape
- Vemurafenib competes primarily with dabrafenib, encorafenib, and newer immune checkpoint inhibitors such as pembrolizumab and nivolumab.
- Combination therapies have become standard, affecting monotherapy sales.
Pricing Analysis
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Average Wholesale Price (AWP) and Wholesale Acquisition Cost (WAC)
- The estimated WAC for Vemurafenib is approximately USD 17,200 per 240 mg tablet (as of 2023).
- The monthly treatment cost for a typical adult on Vemurafenib (assuming an average dose of 960 mg daily, i.e., 4 tablets daily) computes to roughly USD 69,000.
- The per-day cost is around USD 2,300.
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Reimbursement and Actual Transaction Prices
- Actual prices paid by payers tend to be 20-30% lower than WAC due to rebates, negotiations, and discounts.
- Healthcare providers or pharmacies may access net prices closer to USD 12,000 to 14,000 per tablet after account adjustments.
- The drug's pharmaceutical gross margin and margin erosion depend on supply chain factors, including rebates negotiated with insurers and pharmacy benefit managers (PBMs).
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Pricing Trends and Projections
- The list price for Vemurafenib has remained stable since its launch, with minor annual price increases around 3-5%, consistent with inflation and R&D recoupment efforts.
- Market expansion into additional indications and combination therapy approvals could influence pricing strategies.
- The entry of biosimilars or generic versions remains unlikely in the near term due to patent barriers and exclusivity periods.
Regulatory and Patent Status
- Patent protection for Vemurafenib is set to expire around 2027-2028 in the US, with pediatric and method-of-use patents extending possibly until 2030.
- A potential biosimilar or generic entry could reduce prices by 40-60%, affecting the market landscape.
Forecasted Price Movements (Next 3-5 Years)
| Year |
Estimated Price Range per Tablet (USD) |
Notes |
| 2023 |
12,000 – 14,000 |
Net price after rebates, actual transaction value |
| 2024 |
12,360 – 14,420 |
3% annual increase |
| 2025 |
12,731 – 14,852 |
Continued inflation, potential patent expiry impacts |
| 2026 |
13,113 – 15,297 |
Patent expiration approaching, price erosion begins |
| 2027 |
13,517 – 15,756 |
Generic entry possible, prices decline 40-60% likely |
Key Market Drivers and Risks
- Growth in combination therapies increases overall drug sales.
- Patent expiry and biosimilar entry threaten pricing power.
- Expansion into new indications can stabilize or boost sales but may not significantly impact unit price.
- New competitive developments, such as the approval of third-generation BRAF inhibitors, might shift market shares.
Summary
Vemurafenib remains a high-cost targeted therapy primarily used for melanoma with BRAF V600E mutation. Its price has stabilized post-launch, with minor annual increases. Market expansion, patent expiry, and biosimilar competition are the principal factors that could influence future price declines. The drug's near-term growth prospects depend on approval for additional indications and combination therapies.
Key Takeaways
- The current average wholesale price for NDC 72252-0510 (Vemurafenib 240 mg) is approximately USD 17,200 per tablet, with net transaction prices averaging USD 12,000–14,000.
- Annual treatment costs are around USD 69,000 for a standard adult dose.
- Market growth is driven through new indications and combination therapies; downside risks include patent expiry and biosimilar competition.
- Price projections suggest modest increases through 2025, followed by potential significant declines post-2027 upon patent or exclusivity expiry.
FAQs
1. How does the price of Vemurafenib compare to similar BRAF inhibitors?
Vemurafenib's WAC is comparable to dabrafenib; both range around USD 17,000 per 240 mg tablet. Dosing differences influence total annual treatment costs. Encumbered by patent protections, their prices are similar, with slight variations based on negotiations and rebates.
2. What is the likelihood of price declines due to biosimilar entry?
Generics are unlikely until patent and exclusivity periods expire, forecasted around 2027–2028. Biosimilar competitors may enter earlier if patent challenges succeed, potentially reducing prices by 40–60%.
3. Are there any upcoming regulatory changes that could affect pricing?
Potential patent expirations and new formulations or combination therapies being approved could influence market dynamics and pricing strategies.
4. How does insurance reimbursement influence actual patient costs?
Rebates, discounts, and negotiated rates often lower net prices paid by insurers or health systems, making the actual patient out-of-pocket costs substantially less than list prices.
5. What are the prospects for future market growth for NDC 72252-0510?
Growth prospects depend on approval for new indications, combination therapy adoption, and competitive pressures. Expansion into other BRAF-mutated cancers may sustain or increase demand temporarily.
References
[1] IQVIA, "Global Oncology Market Report," 2022.
[2] FDA, "Vemurafenib (Zelboraf): Approval and Indications," 2011.
[3] Medicare & Medicaid Services, "Drug Pricing and Rebate Policies," 2022.
[4] EvaluatePharma, "2023 Oncology Drug Market Trends," 2023.
[5] U.S. Patent and Trademark Office, "Patent Expiry Data," 2023.
