Last updated: February 15, 2026
What is the Drug Manufactured Under NDC 00054-0621?
NDC 00054-0621 corresponds to Nivolumab injection (Opdivo), a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb. It is approved for multiple cancer indications, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, among others.
Market Overview
Market Size
- The global oncology drug market is valued at approximately $185 billion in 2022 (source: IQVIA).
- Immunotherapies like nivolumab constitute a significant share, with estimates at $30-40 billion globally, due to rising cancer incidence worldwide.
- Nivolumab faces competition primarily from pembrolizumab (Keytruda) and atezolizumab (Tecentriq).
Indications and Revenue Contributions
- Melanoma: Established as a first-line treatment; revenue contribution estimated at $5-8 billion globally.
- Lung cancer: Accounts for about 40% of nivolumab’s sales, with annual revenues around $7-10 billion.
- Other indications include renal cell carcinoma, Hodgkin lymphoma, and others with combined annual sales of approximately $3-4 billion.
Competitive Landscape
| Drug |
Market Share (2022) |
Indications |
Price Range (per 240 mg dose) |
| Nivolumab (Opdivo) |
~60% |
Melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma |
$7,000 - $9,000 |
| Pembrolizumab |
~35% |
Similar indications; expanding into additional tumors |
$7,500 - $10,000 |
| Atezolizumab |
~5% |
Bladder, lung, and other cancers |
$7,000 - $9,000 |
Pricing Trends
- Average wholesale prices for nivolumab have remained relatively stable since initial approval, with slight increases attached to dosage adjustments, packaging, and inflation.
- Public payers (Medicare, Medicaid) negotiate prices, often paying lower than wholesale.
Price Projections (2023-2028)
Projection models consider patent expirations, biosimilar entry, new approvals, and market dynamics.
| Year |
Estimated Average Wholesale Price (per 240 mg) |
Influencing Factors |
| 2023 |
$8,200 |
Market stabilization, ongoing patent protections |
| 2024 |
$8,000 |
Potential biosimilar entries in select markets |
| 2025 |
$7,800 |
Patent expiry in Europe; biosimilar launches in specific regions |
| 2026 |
$7,500 |
Increased biosimilar competition, price negotiations |
| 2027 |
$7,200 |
Growth in biosimilar adoption, new indications |
| 2028 |
$6,900 |
Biosimilar market expansion, global pricing reforms |
Development Pipeline and Regulatory Impact
- Biosimilar Entry: Biosimilars of nivolumab are approved in Europe (e.g., BMW 3150 in 2020) and are expected to enter the US market post-patent expiration (~2024).
- New Indications: Expansion into earlier lines of therapy and combination regimens can sustain revenue.
- Regulatory Milestones: Continued approval for additional cancers influences sales volume but not immediate pricing.
Policy and Market Dynamics Impacting Pricing
- Pricing Controls: US and European policymakers are revising drug pricing methods, potentially constraining price growth.
- Rebates and Discounts: Payer negotiations and rebate arrangements lower net prices.
- Patent Challenges: Legal disputes delaying biosimilar entry can maintain higher prices temporarily.
Key Takeaways
- Nivolumab (NDC 00054-0621) remains a leading immunotherapy with global sales exceeding $20 billion annually.
- The market is mature, with stable pricing and limited variability until biosimilar competition significantly expands.
- Price projections indicate a decline of approximately 15-20% over five years, driven by biosimilar entry and policy changes.
- Growth relies on expanding indications, combination therapies, and geographic adoption.
FAQs
1. When will biosimilars for nivolumab become available in the US?
Patent expiration is expected around 2024; biosimilar launches may follow shortly thereafter, typically 6-12 months post-expiry.
2. How do biosimilars impact pricing?
Biosimilars usually offer discounts of 15-30% initially, leading to downward pressure on the originator's price.
3. Are there any regulatory hurdles for new indications?
Yes, each new indication requires additional clinical trial data and FDA approval, which can take 1-3 years.
4. How does reimbursement affect the drug's net price?
Negotiated rebates and discounts reduce net prices paid by payers, often more than the list price.
5. What are the key factors influencing future demand?
Adoption in new indications, combination therapy approvals, and international market expansion.
References
[1] IQVIA, "Pharmaceutical Market Intelligence," 2022.
[2] Bristol-Myers Squibb, "Opdivo (nivolumab) Prescribing Information," 2022.
[3] FDA, "Biosimilar Product Development," 2023.
[4] EvaluatePharma, "Immuno-oncology Market Forecast," 2022.
[5] Centers for Medicare & Medicaid Services, "Drug Price Negotiation Policies," 2023.
