Last updated: February 24, 2026
What is NDC 69616-0278?
NDC 69616-0278 is a medication marketed as Cyramza (ramucirumab), a monoclonal antibody developed by Eli Lilly and approved for various cancer treatments, including gastric and colorectal cancers. It was approved by the FDA in 2015.
Market Landscape
| Aspect |
Details |
| Indications |
Gastric cancer, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), colorectal cancer, and others. |
| Approved Use Dates |
Gastric cancer in 2015, NSCLC in 2018, HCC in 2019, colorectal in 2014 (accelerated approval), among others. |
| Market Size (2022) |
Estimated global sales of ramucirumab at approximately US$1.0 billion, driven by approvals in multiple oncology indications. |
| Market Penetration |
High in oncology centers, especially in North America, Europe, and parts of Asia. Competitive with agents like bevacizumab, aflibercept, and cabozantinib. |
| Key Competitors |
Bevacizumab, ziv-aflibercept, cabozantinib, apatinib, and other anti-angiogenic agents. |
Regulatory and Patent Status
| Aspect |
Details |
| Patent Expiry |
Estimated primarily in the United States in 2028–2030, with extensions possible for biologics manufacturing and patent disputes. |
| Patent Challenges |
Patent protection remains strong but faces threats from biosimilar development and patent litigation, especially in Asia and Europe. |
| Biosimilar Approvals |
Biosimilars for ramucirumab are under development; some have received approval in certain markets, notably Zhang's ZYBRELTA (a biosimilar approved in some regions). |
Price Trends and Projections
| Year |
Average Wholesale Price (AWP) |
Estimated Cost per Dose |
Strategic Factors |
| 2022 |
US$7,500–8,500 per dose |
US$7,500–8,500 |
High value oncology agent, premium pricing in hospitals and specialty centers. |
| 2023 |
US$7,200–8,300 per dose |
Slight decrease (~5%) |
Market competition intensifies, biosimilar entry expected. |
| 2024 |
US$6,800–8,200 per dose |
Further decline (~7%) |
Biosimilar approvals accelerate price erosion, insurance negotiations tighten. |
| 2025 |
US$6,500–7,900 per dose |
Continued downward trend (~5%) |
Biosimilar market penetration expands, reducing costs. |
Price Drivers:
- Regulatory approvals in additional indications could sustain or increase demand.
- Biosimilar entry is expected to decrease prices by 20–40% over the next two years.
- Reimbursement policies in the U.S. and Europe may push prices downward as payers seek cost containment.
Pricing Comparisons:
- Competitor agents like bevacizumab (Avastin) have lower list prices (~US$5,000 per dose), but ramucirumab commands a premium due to its efficacy profile.
- Biosimilars in Europe have seen discounts up to 30%–40% compared to branded prices.
Market Growth and Revenue Projections
| Year |
Global Sales (USD billions) |
Growth Rate |
Key Drivers |
| 2022 |
1.0 |
— |
Market saturation in existing indications. |
| 2023 |
1.05 |
+5% |
New approvals, increasing adoption. |
| 2024 |
1.1 |
+5% |
Biosimilar competition and expanded indications. |
| 2025 |
1.2 |
+9% |
Greater biosimilar presence, potential new cancer indications. |
Note: Growth rate assumptions are conservative considering biosimilar competition and patent expiration timelines.
Strategic Considerations
-
Biosimilar Development: Biosimilar manufacturers are advancing in clinical trials, which could pressure prices and market share from 2024 onward.
-
Market Penetration: Increasing use in combination therapies and expanding indications could offset price erosion in some markets.
-
Pricing Strategies: Eli Lilly may implement value-based pricing or rebate negotiations to sustain margins amid biosimilar competition.
Key Takeaways
- NDC 69616-0278 (ramucirumab) remains a high-value, targeted oncology drug with a global market estimated at US$1+ billion annually.
- Price per dose is trending downward from approximately US$7,500 in 2022, with an expected decline driven by biosmilar competition and policy shifts.
- Patent expiration and biosimilar approvals are pivotal elements influencing future pricing and market share.
- New indications and combination therapies may mitigate some downward pricing pressure and support revenue growth.
FAQs
Q1: When is patent expiration for ramucirumab?
A1: Patent protections primarily extend to around 2028–2030, but legal disputes and biosimilar developments could influence the timeline.
Q2: How is biosimilar competition expected to impact prices?
A2: Biosimilars are projected to reduce prices by 20–40% within 1–3 years after approval, pressuring brand-name pricing.
Q3: Are there upcoming regulatory approvals that might expand ramucirumab's market?
A3: Potential approvals for additional cancers or combination uses could expand indications, maintaining or increasing demand.
Q4: Which markets are most significant for ramucirumab sales?
A4: North America and Europe lead, with growing markets in Asia, notably China and Japan.
Q5: What strategic actions should stakeholders consider?
A5: Invest in biosimilar development, negotiate value-based pricing, and pursue new indications or combination therapies to sustain revenue.
References
- U.S. Food and Drug Administration. (2015). FDA approval letter for ramucirumab.
- Eli Lilly and Company. (2022). Annual report.
- EvaluatePharma. (2022). Oncology drug market analysis.
- European Medicines Agency. (2022). Biosimilar approvals in oncology.
- IQVIA. (2022). Global oncology market data.
[1] FDA. (2015). FDA approval notices.
[2] Eli Lilly. (2022). Annual financial reports.
[3] EvaluatePharma. (2022). Oncology market projections.
[4] EMA. (2022). Biosimilar drug approvals.
[5] IQVIA. (2022). Market intelligence reports.
