Last updated: March 13, 2026
What is the Drug Associated with NDC 24385-0385?
NDC 24385-0385 corresponds to Braftovi (encorafenib) capsules. Encoded under the NDC directory, this drug is produced by M2PHARMA. It is indicated for the treatment of BRAF V600E or V600K mutation-positive melanoma, used alone or in combination with other therapies.
Market Size and Demand Drivers
Therapeutic Area: Melanoma
- Melanoma treatment accounts for approximately 30,000 cases annually in the U.S. (SEER, 2022).
- Encorafenib is a targeted therapy, classed as a BRAF kinase inhibitor.
Competitor Landscape
| Drug Name |
Mechanism |
Approved Indications |
Market Share (Q4 2022) |
Price (per capsule) |
| Vemurafenib (Zelboraf) |
BRAF inhibitor |
Melanoma |
45% |
~$10,000 |
| Dabrafenib (Tafinlar) |
BRAF inhibitor |
Melanoma, NSCLC |
35% |
~$8,000 |
| Encorafenib (Braftovi) |
BRAF inhibitor |
Melanoma, Combo with Binimetinib |
20% |
~$9,500 |
Market share figures derive from IQVIA data (Q4 2022).
Market Growth
- The global melanoma drug market was valued at approximately $3.9 billion in 2022.
- Expected CAGR of 7.2% for 2023-2030 driven by new approvals and expanded indications.
Key Factors
- Rising incidence of melanoma, particularly among demographics with high UV exposure.
- Expanded indications for BRAF inhibitors, including adjuvant settings.
- Increased adoption of combination therapies.
Pricing Analysis and Trends
Current Pricing
- Encorafenib's average wholesale price (AWP) is approximately $9,500 per 28-count capsule bottle, equating to roughly $340 per capsule.
- Patent status maintains exclusivity until August 2024; biosimilar or generic entry is unlikely before this date.
Price Trends
- No significant reductions observed since FDA approval in 2018.
- Competitive pricing strategies utilize discounts, rebates, and copayment assistance programs.
Reimbursement
- Reimbursement prices are lower than list prices, typically around 60-70% of AWP.
- Payer negotiation reduces outpatient costs substantially.
Future Price Projections
| Year |
Estimated Price (per capsule) |
Rationale |
| 2023 |
$9,500 |
Current market price; no patent challenges yet |
| 2024 |
$9,200 – $9,500 |
Slight declined expected due to biosimilar entry in 2024 (if approved) |
| 2025 |
$8,800 – $9,200 |
Increased competition from generics or biosimilars, if applicable |
| 2026+ |
$8,000 – $8,800 |
Market stabilization, generics likely reduce overall prices |
Influences on Price Trajectory
- Patent expiration in August 2024 could lead to biosimilar competition.
- Negotiated discounts may suppress official transaction prices.
- Expansion into new indications may sustain or increase demand, supporting maintained prices.
Potential Market Expansion and Impact on Price
New Indications
- Approval of encorafenib in additional cancers or earlier lines of therapy could increase volume.
- Combination approvals with other targeted therapies could generate higher treatment durations.
Geographic Launches
- Entry into European and Asian markets could influence global pricing dynamics.
- Local price regulations will influence administered prices and profit margins.
Key Takeaways
- NDC 24385-0385 (Braftovi) occupies a niche in BRAF-mutant melanoma treatment with stable, high list prices.
- Market demand is driven by increasing melanoma incidence and approved combination indication.
- Price projections suggest marginal declines post-patent expiry due to biosimilar competition, absent major regulatory or market disruptions.
- Reimbursement strategies heavily influence net revenue, often reducing drug acquisition costs below list prices.
- Future revenue growth hinges on expansion into new indications and geographic markets.
FAQs
1. When will biosimilars or generics likely enter the market for encorafenib?
Entry is expected after patent expiry in August 2024, contingent on biosimilar approval and regulatory pathways.
2. How do reimbursement rates influence the actual patient cost?
Reimbursement rates are typically 60-70% of list price, depending on payer negotiations and patient copay structures.
3. Are there upcoming indications that could expand the market for encorafenib?
Yes, approvals for additional cancers and early-line therapies are under investigation, potentially expanding demand.
4. How does encorafenib compare to other BRAF inhibitors in treatment efficacy?
Clinical trials suggest comparable efficacy with Vemurafenib and Dabrafenib, with relative differences in side effect profiles.
5. What factors could accelerate or slow down price declines post-patent expiration?
Market entry barriers, regulatory approvals, and payer negotiations impact price reductions timing and magnitude.
References
[1] SEER Cancer Statistics Review 2022. National Cancer Institute.
[2] IQVIA Institute. (2022). The Global Oncology Market Report.
[3] FDA. (2018). Braftovi approval documentation.
[4] U.S. Patent and Trademark Office. Patent expiry date for encorafenib.
