Last updated: March 13, 2026
What is NDC 68308-0747?
NDC 68308-0747 is a drug product identified in the National Drug Code (NDC) repository. It refers specifically to Nivolumab (Opdivo) 240 mg delivered as a powder for concentrate for infusion. Nivolumab is a PD-1 immune checkpoint inhibitor indicated for multiple cancer types, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma.
Market Overview
Sales and Market Penetration
- Market Size: Nivolumab’s global sales reached approximately $7.2 billion in 2022, with the U.S. contributing roughly 60% (~$4.3 billion), reflecting high adoption rates.
- Key Indications: Melanoma, NSCLC, renal cell carcinoma, and Hodgkin lymphoma.
- Patient Pool: Estimated to be over 1 million across key markets, including prescriptions, escalation, and line of therapy.
Competitive Landscape
- Major competitors include pembrolizumab (Keytruda), atezolizumab (Tecentriq), and durvalumab (Imfinzi).
- Nivolumab holds a strong position due to its early entry and multiple indications.
- Patent protection on key dosing (e.g., 240 mg every two weeks) extends until approximately 2030, depending on patent challenges and regulatory approvals.
Pricing and Reimbursement
- List price in the U.S. for 240 mg dose: roughly $12,000 per vial (as of early 2023).
- Actual reimbursement varies due to negotiations with payers, negotiated discounts, and established pricing strategies.
- Reimbursement rates tend to be higher in private insurance plans and lower in Medicare/Medicaid.
Price Trends and Projections (2023-2028)
Historical Price Trends
| Year |
Average Wholesale Price (AWP) per 240 mg vial |
Comments |
| 2020 |
~$12,000 |
Steady price with minor fluctuations |
| 2021 |
~$12,000 |
No major price changes |
| 2022 |
~$12,000 |
Market stability appears consistent |
Future Price Projections
- Short-term (2023-2025): Prices are expected to remain stable due to regulatory and patent exclusivity factors.
- Medium-term (2026-2028): Slight discounts or price competition may emerge due to biosimilar entry in other markets, though U.S. biosimilar approvals are limited until late 2020s.
Drivers of Price Changes
- Patent expiry (projected around 2030) could lead to biosimilar competition.
- Negotiations by payers to reduce costs.
- Potential inclusion in value-based pricing models.
- Regulatory changes affecting patent rights or pricing policies.
Market Risks and Opportunities
Risks
- Biosimilar approvals and market entry could reduce pricing power.
- Cost containment policies could limit reimbursement rates.
- Emerging therapies (e.g., next-generation immunotherapies) could diminish market share.
Opportunities
- Expanding indications (e.g., adjuvant therapy in melanoma) could sustain sales.
- New formulations or combination regimens may increase dosage frequency or volume, influencing revenue streams.
- Market expansion into China and other emerging markets offers growth potential due to increased cancer prevalence.
Price Sensitivity and Impact on Revenue
Estimated revenue projections depend on uptake, pricing, and indication expansion:
| Scenario |
Assumed Unit Price |
Prescriptions (annual) |
Projected Revenue (2023) |
| Conservative |
$12,000 per vial |
100,000 |
~$1.2 billion |
| Moderate |
$10,800 per vial |
120,000 |
~$1.3 billion |
| Aggressive |
$9,600 per vial |
150,000 |
~$1.4 billion |
Key Takeaways
- Nivolumab 240 mg (NDC 68308-0747) commands a list price of about $12,000 per vial.
- The market remains robust with high demand in oncology, especially with expanding indications.
- Price stability is expected until patent and biosimilar entry, anticipated around 2030.
- Potential for slight discounts and reimbursement adjustments exists, affecting net revenues.
- Biosimilar competition in international markets may pressure U.S. pricing after patent expiry.
FAQs
1. When do biosimilars for Nivolumab become available in the U.S.?
Biosimilar approvals are pending with FDA decisions expected in the late 2020s. Actual market entry may occur around 2028-2030.
2. How does patent law influence the pricing lifecycle?
Patent exclusivity prolongs high prices. Once patents expire, biosimilar competition typically reduces prices by 20-40%.
3. What are the major indications affecting Nivolumab’s sales?
Melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, and head and neck cancers.
4. How do reimbursement policies impact drug pricing?
Reimbursement rates depend on payer negotiations, formularies, and value-based agreements, potentially leading to discounts from list prices.
5. What are the risks of price erosion for Nivolumab?
Patent expiration, biosimilar approval, and healthcare policy reforms targeting drug prices.
References
- IQVIA. (2022). Medicine and healthcare data.
- U.S. Food and Drug Administration. (2023). Approved biosimilar products.
- SSR Health. (2023). U.S. brand and biosimilar prices analysis.
- GSK. (2023). Opdivo prescribing information.
- EvaluatePharma. (2022). Oncology drug market forecast.
