Last updated: February 24, 2026
What is NDC 00904-7282?
NDC 00904-7282 refers to a specific drug identified in the National Drug Code (NDC) system. Based on publicly available data, it corresponds to Nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor used in oncology treatments.
Market Overview
Therapeutic Area and Indications
Nivolumab is approved for multiple oncologic indications, including:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Other cancers (see FDA approvals, 2023)
Market Size and Share
The global oncology immunotherapy market was valued at approximately USD 70 billion in 2022. Nivolumab holds a significant market share, with revenues reaching USD 7.2 billion in 2022, marking its position as a leading PD-1 inhibitor.
Key Competitors
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Cemiplimab (Libtayo)
Market Drivers
- Expanding indications
- Increasing prevalence of cancers
- Advancements in immunotherapy combination regimens
Regulatory Status
- Approved by FDA since 2014
- Available via outpatient clinics and hospital formularies
- On-label broad-spectrum use, with ongoing trials for additional indications
Price Projection Factors
Current Pricing Metrics
- Wholesale Acquisition Cost (WAC): approximately USD 14,500 per 40 mg dose
- Average patient dose: 240 mg every 2 weeks
- Estimated cost per cycle: USD 86,500
Pricing Trends
The price for nivolumab has remained relatively stable over the past five years, with minor inflation-adjusted increases of 2-3% annually. Rebate schemes and managed care negotiations influence net prices.
Future Price Considerations
- Market Competition: Entry of biosimilars and competing therapies could pressurize prices.
- Regulatory Changes: Price regulation initiatives in key markets (e.g., U.S., EU) might impact margins.
- Patent Expirations: Patent expiry is projected around 2028, potentially enabling biosimilar entry.
Forecast Scenarios
| Scenario |
Assumptions |
Price Trend |
Projected Price (USD) by 2028 |
| Base Case |
Stable market share, limited biosimilar competition |
2% annual increase |
USD 105,000 per 40 mg dose |
| Conservative |
Increased biosimilar competition, policy price controls |
5% decrease |
USD 11,000 per 40 mg dose (biosimilar entry) |
| Aggressive |
Market expansion and new indications, limited biosimilar impact |
3% annual growth |
USD 110,000 per 40 mg dose |
Market Entry and Cost Impact
Entry of biosimilars anticipated post-2028 could reduce prices by 40-60%. Managed care contracts may further lower net prices.
Revenue Impact
- U.S. annual sales projected at USD 7.2 billion (2022)
- Potential decline of 20-40% within five years post-biosimilar entry, barring new indications
- Global sales growth may continue at 4-6% annually with pipeline expansion
Regulatory and Payment Landscape
- U.S. coverage by Medicare Part B
- Price negotiations under Medicare payment reform proposals
- EU price and reimbursement policies vary by country
Summary of Price Expectation Outlook
| Year |
Price per 40 mg dose (USD) |
Notes |
| 2023 |
USD 14,500 |
Current pricing |
| 2025 |
USD 15,000 (base case) |
Slight inflationary trend |
| 2027 |
USD 16,000 (base case) |
Market growth continues |
| 2028 |
USD 16,500 (base case) |
Patent expiry approaches |
Key Takeaways
- Nivolumab maintains a strong market position; prices are relatively stable but subject to biosimilar competition post-2028.
- Revenue projections depend heavily on regulatory decisions, indication expansion, and market competition.
- Biosimilar entrants could significantly lower prices, affecting revenues and market share.
FAQs
-
When is the patent for Nivolumab expected to expire?
It is projected around 2028, enabling biosimilar entry.
-
How does biosimilar competition affect nivolumab prices?
Biosimilars could reduce prices by 40-60%, depending on market penetration and regulatory approval.
-
What are the main indications for NDC 00904-7282?
Melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, among others.
-
What factors could influence the price decline?
Patent expiration, biosimilar availability, payer negotiations, and regulatory policies.
-
What is the global market outlook?
Continuing revenue growth at 4-6% annually, driven by pipeline expansions and indication approvals.
References
[1] U.S. Food and Drug Administration. (2023). Approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] IQVIA. (2022). Oncology Market Reports.
[3] EvaluatePharma. (2022). World Preview 2027: Outlook for Oncology Drugs.
[4] Medicare.gov. (2023). Coverage & Pricing.
[5] Reuters. (2022). Biosimilar Market Dynamics in Oncology.
