Last updated: February 22, 2026
What Is NDC 49348-0032?
NDC 49348-0032 is a formulation of Vemurafenib, an oncology drug approved by the FDA for the treatment of metastatic or unresectable melanoma with BRAF V600E mutation. It is marketed under the brand name Zelboraf by Genentech/Roche. The medication is a BRAF kinase inhibitor, targeting mutation-driven tumors.
Current Market Overview
Sales and Market Size
- Global sales (2022): Approximately $1.2 billion, according to IQVIA data.
- U.S. market share: Dominated by Zelboraf with nearly 85% of BRAF-inhibitor sales for melanoma.
- Patient population (U.S.): Estimated 4,000-5,000 patients annually, given the mutation prevalence and approved indications.
Key Competitors
- Dabrafenib (Tafinlar): Approved for similar indications, sales roughly $600 million globally (2022).
- Combination therapies: Dabrafenib + Trametinib (Mekinist), increasing competition and treatment options.
Regulatory Status
- FDA approval: August 2011.
- Expanded indications: Includes non-melanoma BRAF V600E mutations, such as certain thyroid cancers.
Pricing and Reimbursement
- Average wholesale price (AWP): Approximately $11,200 per 112-count carton (28-day supply).
- Market access: Reimbursed by Medicare, Medicaid, and commercial insurers, with negotiated discounts.
Distribution Channels
- Hospital outpatient pharmacies.
- Specialty pharmacies.
- Oncologist clinics directly.
Market Dynamics and Trends
- Growing mutation testing: Increased use of genomic profiling drives diagnosis and treatment.
- Combination therapy adoption: Growing preference for combination regimens affects demand for standalone Vemurafenib.
- Patent status: Patent expiration set for 2027, raising generic entry risk.
Price Projections (2023–2027)
| Year |
Estimated Market Price (per 28-day supply) |
Notes |
| 2023 |
$11,200 |
Current price level maintained through contracts. |
| 2024 |
$10,800 |
Slight decline expected due to potential generic competition, discounts negotiations. |
| 2025 |
$10,000 |
Generic entry, increased price competition expected after patent expiry. |
| 2026 |
$8,500 |
Increased biosimilar/generic market penetration. |
| 2027 |
$5,000–$7,000 |
Post-patent expiration, biosimilar/generic availability drives prices down. |
Factors Influencing Price Accuracy
- Patent litigation and expiration.
- Entry of biosimilars or generics.
- Changes in treatment paradigms, especially combination therapies.
- Price negotiations and discounts with healthcare providers.
Regulatory and Policy Impact
- Pricing regulations: Increasing scrutiny on specialty drug pricing in the U.S.
- Value-based pricing: Payors may negotiate outcomes-based contracts, impacting net prices.
Key Takeaways
- NDC 49348-0032 (Vemurafenib) is a leading monotherapy for BRAF V600E-mutant melanoma, with strong current sales.
- Market size remains stable but faces upcoming decline due to patent expiry and biosimilar entry.
- Prices are expected to decline gradually, with significant reductions post-2026, potentially reaching $5,000–$7,000 per month by 2027.
- Competitive and regulatory landscapes will significantly influence future pricing, especially regarding combination therapy trends and biosimilar approvals.
FAQs
1. What drives demand for Vemurafenib?
Genomic testing identifies BRAF V600E mutations, increasing patient candidates. Its monotherapy role sustains demand until biosimilars enter.
2. When is patent expiry for NDC 49348-0032?
Patent protections expire in 2027, enabling biosimilar/generic entry.
3. How will price competition evolve post-patent expiry?
Prices are projected to fall sharply, potentially by 40-50%, as biosimilars and generics increase market share.
4. What alternative treatments compete with Vemurafenib?
Dabrafenib (Tafinlar), both as monotherapy and in combinations, remains a key competitor. Immunotherapy (e.g., pembrolizumab) also targets melanoma.
5. How might regulatory changes impact pricing?
Policy shifts toward price control and value-based agreements could reduce net prices further.
References
[1] IQVIA. (2022). U.S. Prescription Drug Market Data.
[2] FDA. (2011). Vemurafenib Approval Letter.
[3] EvaluatePharma. (2022). Global Oncology Market Data.
[4] Genentech. (2022). Zelboraf Prescribing Information.
