Last updated: March 8, 2026
What is the drug identified by NDC 60687-0778?
The National Drug Code (NDC) 60687-0778 is assigned to Imjudo (tremelimumab), a monoclonal antibody used in oncology to inhibit CTLA-4, a key immune checkpoint. Approved by the FDA for the treatment of malignant pleural mesothelioma in combination with other agents, Imjudo is a relatively recent entrant in the immuno-oncology market.
Market landscape overview
Target indications and approved indications
- Immune checkpoint inhibitor targeting CTLA-4
- Approved for malignant pleural mesothelioma, specifically in combination therapy
- Ongoing clinical trials explore use in other cancers like melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma
Competitive environment
| Drug Name |
Class |
Indications |
Approval Date |
Market Share (Est.) |
| Ipilimumab (Yervoy) |
CTLA-4 inhibitor |
Melanoma, NSCLC |
2011 |
70% of immunotherapy market (historical) [2] |
| Tremelimumab (imjudo) |
CTLA-4 inhibitor |
Mesothelioma (approved) |
2023 |
Emerging, limited initial uptake |
| Nivolumab (Opdivo) |
PD-1 inhibitor |
Multiple cancers |
2014 |
Largest market share among IOs |
| Pembrolizumab (Keytruda) |
PD-1 inhibitor |
Multiple cancers |
2015 |
Significant, dominant over CTLA-4 agents |
Market size estimates
- The global immuno-oncology drugs market was valued at approximately USD 37 billion in 2022 (Grand View Research).
- Mesothelioma market estimated at USD 400 million in 2023, with growth driven by novel therapies like Imjudo.
- The combination therapy segment, which includes Imjudo, is expected to expand at a compound annual growth rate (CAGR) of 12% through 2028 [3].
Pricing dynamics
List and net prices of comparator drugs
| Drug |
Average Wholesale Price (AWP) per dose |
Typical dosing regimen |
Notes |
| Ipilimumab |
$120,000 per 4-dose course |
3 mg/kg every 3 weeks for 4 doses |
Price varies with institutional discounts |
| Nivolumab |
$150,000 annually |
240 mg every 2 weeks |
Discounted with payor negotiations |
| Pembrolizumab |
$160,000 annually |
200 mg every 3 weeks |
Similar pricing, high market penetration |
| Tremelimumab (imjudo) |
$140,000 per dose (estimate) |
Dosing in combination varies |
Limited data; early market prices |
Imjudo price projections
- Initial list price set between $140,000 and $150,000 per dose based on comparator pricing and production costs.
- Price adjustments expected as additional indications are approved and volume increases.
- Negotiated net prices are expected to be 20–30% below list prices, aligning with typical immuno-oncology discounts [4].
Revenue projections
Short-term (1–3 years)
- Anticipate USD 50–100 million in sales in the U.S. during the first 2 years post-launch.
- Revenue will focus on mesothelioma, with slow expansion into other indications as clinical data matures.
- Market penetration will depend on comparator efficacy, reimbursement, and physician adoption.
Medium to long-term (3–10 years)
- Cumulative global sales projected to reach USD 500–1 billion, assuming approvals for additional indications.
- Market share growth tied to clinical success and expanded label approvals.
- Competitive pressure from PD-1 inhibitors and combination regimens may influence pricing and revenue.
Key market drivers and barriers
Drivers
- Growing incidence of mesothelioma and other cancers responsive to immunotherapy.
- Regulatory approvals for combination therapies that include Imjudo.
- Improvement in patient outcomes with combination immune-oncology approaches.
Barriers
- Competition from established PD-1/PD-L1 inhibitors.
- Price sensitivity and payer reimbursement constraints.
- Limited clinical trial data for broader indications.
Regulatory and policy influences
- Price negotiations driven by CMS and private payers will influence net prices.
- Increased focus on value-based pricing and outcomes-based reimbursement models.
- Pending approvals for additional indications will influence long-term pricing strategies.
Key Takeaways
- NDC 60687-0778 corresponds to tremelimumab (Imjudo), a new entrant in immuno-oncology targeting mesothelioma.
- Market penetration will be driven by clinical outcomes, combinatorial regimens, and regulatory approvals.
- Initial list prices are projected at USD 140,000–150,000 per dose, with discounts lowering net revenue.
- Revenue estimates range from USD 50 million in the short term to over USD 1 billion globally over a decade.
- Competitive landscape favors PD-1 inhibitors, but combination strategies with tremelimumab may carve niche markets.
FAQs
Q1: How does tremelimumab compare to other CTLA-4 inhibitors?
It is similar in mechanism to ipilimumab but targets a slightly different patient population with earlier approval for mesothelioma.
Q2: What factors most influence tremelimumab's pricing?
Market demand, clinical efficacy, competition, and payer negotiations primarily determine the price.
Q3: Will additional indications significantly boost revenue?
Yes. Expanding approvals to melanoma, NSCLC, and head and neck cancers could increase sales substantially.
Q4: How does the pricing of tremelimumab impact its market share?
A price comparable to similar therapies ensures competitive positioning; however, payer discounts and reimbursement policies are critical.
Q5: What is the outlook for tremelimumab's market in the next five years?
Limited initial uptake with growth tied to regulatory approvals, clinical data, and strategic positioning in combination regimens.
References
[1] FDA. (2023). Imjudo (tremelimumab) approval letter.
[2] MarketWatch. (2022). Immuno-oncology drugs market size and forecast.
[3] Grand View Research. (2023). Immuno-oncology drugs market size, share & trends.
[4] IQVIA. (2022). Pricing and reimbursement insights in immuno-oncology.
