Ramucirumab - Biologic Drug Details

Summary for ramucirumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ramucirumab

Recent Clinical Trials for ramucirumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
AstraZeneca	PHASE1

See all ramucirumab clinical trials

Pharmacology for ramucirumab

Mechanism of Action	VEGFR2 Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Receptor 2 Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ramucirumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ramucirumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	7,498,414	2023-03-04	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	8,057,791	2028-09-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ramucirumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,111,968	2036-08-10	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,189,822	2036-03-15	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,220,072	2037-12-06	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,227,328	2036-02-02	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,238,656	2035-02-19	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,259,859	2036-08-05	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477	10,260,097	2032-06-04	Patent claims search

International Patents for ramucirumab

Country	Patent Number	Estimated Expiration
European Patent Office	2298346
World Intellectual Property Organization (WIPO)	03075840
European Patent Office	1916001
Japan	2009148298
Cyprus	1111629
Japan	4970483
Portugal	1487856

Supplementary Protection Certificates for ramucirumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15C0034	France		PRODUCT NAME: RAMUCIRUMAB; REGISTRATION NO/DATE: EU/1/14/957 20141223
2015/026	Ireland		PRODUCT NAME: RAMUCIRUMAB; REGISTRATION NO/DATE: EU/1/14/957 20141219
C20150018 00146	Estonia		PRODUCT NAME: RAMUTSIRUMAB;REG NO/DATE: EU/1/14/957 23.12.2014
C01916001/01	Switzerland		PRODUCT NAME: RAMUCIRUMAB; REGISTRATION NO/DATE: SWISSMEDIC 65206 29.10.2015
CA 2015 00027	Denmark		PRODUCT NAME: RAMUCIRUMAB; REG. NO/DATE: EU/1/14/957/001-003 20141219
2015C/027	Belgium		PRODUCT NAME: RAMUCIRUMAB; AUTHORISATION NUMBER AND DATE: EU/1/14/957 20141223
SPC/GB15/032	United Kingdom		PRODUCT NAME: RAMUCIRUMAB, A HUMAN IGG1 ANTI-VEGF RECEPTOR 2 MONOCLONAL ANTIBODY; REGISTERED: UK EU/1/14/957 20141223

Market Dynamics and Financial Trajectory for the Biologic Drug: Ramucirumab

Last updated: December 6, 2025

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Executive Summary

Ramucirumab (marketed as Cyramza by Eli Lilly and Company) has established itself as a pivotal agent in the treatment of various cancers, including gastric, colorectal, non-small cell lung, and hepatocellular carcinomas. Since its FDA approval in 2014, ramucirumab's commercial landscape has experienced significant growth, buoyed by expanding indications, robust pipeline potential, and strategic collaborations. This analysis delineates the current market forces influencing ramucirumab, forecasts its financial trajectory, and explores key factors shaping its future in a competitive oncology biologics segment.

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1. What Are the Current Market Dynamics Surrounding Ramucirumab?

1.1. Market Penetration and Indications Expansion

• Initial Indications and Approvals:

  • Gastric and gastroesophageal junction (GEJ) adenocarcinoma: FDA approval in 2014 based on the REGARD trial.
  • Non-small cell lung cancer (NSCLC): Approved in 2015 for second-line treatment.
  • Colorectal cancer: Approved in 2015 for metastatic cases post-chemotherapy.
  • Hepatocellular carcinoma (HCC): Approved in 2019 for unresectable cases.

• Indications Pipeline:
  Ongoing trials aim for additional approvals in ovarian, breast, and pancreatic cancers, which could significantly expand its market base.

• Geographical Expansion:
  Strong presence in the U.S., Europe, and select Asian markets, with emerging opportunities in Latin America and Africa.

1.2. Competitive Landscape

Competitor	Key Drugs	Mechanism	Market Positioning	Notes
Bevacizumab	Avastin (Roche)	VEGF inhibitor	Broad spectrum in metastatic cancers	Established, first-mover advantage
Aflibercept	Zaltrap (Regeneron)	VEGF trap	Used in colorectal cancer	Market share overlapping with ramucirumab
Others	Atezolizumab, Nivolumab	Immune checkpoint inhibitors	Growing segment	Competition in combinatorial regimens

• Ramucirumab competes primarily within anti-angiogenic biologics, facing pressure from newer immunotherapy combinations.

1.3. Pricing and Reimbursement Environment

• Pricing Strategy:

  • Approximate wholesale acquisition costs (2023): \$9,000 to \$12,000 per month (USA).
  • Pricing varies across regions due to reimbursement frameworks.

• Reimbursement Landscape:

  • Favorable in developed markets with established payment mechanisms, though price controls in Europe and APAC regions pose challenges.

1.4. Market Drivers and Restraints

Drivers	Restraints
Expansion of approved indications	High treatment costs
Emerging biomarker-driven patient selection	Competition from immuno-oncology agents
Growing prevalence of target cancers	Patents and biosimilar threats (pending)

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2. What Is the Financial Trajectory Forecast for Ramucirumab?

2.1. Revenue Estimates and Growth Projections

Year	Estimated Revenue (USD)	Growth Rate	Commentary
2023	\$1.2 billion	—	Steady growth driven by pipeline and existing indications
2025	\$1.4 - \$1.6 billion	16-33%	Anticipated expansion with new indications and geographies
2030	\$2.0+ billion	Potential high growth	Potential pipeline success and combination therapy approvals

2.2. Key Revenue Drivers

• Existing Indications:

  • Gastric/GEJ, NSCLC, colorectal, and HCC account for 70-80% of sales.

• Pipeline and Combinatorial Approvals:

  • Upcoming trials may open additional revenue streams, including potential indications in ovarian and pancreatic cancers.

• Geographical Expansion:

  • Asian markets and emerging economies projected to contribute significantly by 2025.

2.3. Cost and Investment Considerations

• Manufacturing Expenses:

  • Biologics production costs (~40-60% of gross margins), with improvements driven by biosimilar competition.

• R&D Investment:

  • Continuous investment (~$300-$400 million annually) to support pipeline trials and label expansions.

2.4. Risks Impacting Financial Outlook

Risk Factors	Impact	Mitigation
Patent expiration (~2028-2030)	Revenue decline	Diversification into novel combinations and indications
Competition from immunotherapies	Market share erosion	Combination strategies to maintain positioning
Regulatory hurdles	Delays in approvals	Strategic collaborations with regulatory agencies

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3. How Does Ramucirumab Compare to Similar Biologics in Oncology?

Parameter	Ramucirumab	Bevacizumab	Aflibercept	Ramucirumab Advantage
Approval Year	2014	2004	2012	Longer clinical experience for bevacizumab
Indications	Multiple cancers	Multiple cancers	Colorectal, diabetic retinopathy	Broader oncology indications
Price Point	~$9,000–$12,000/month	Similar	Slightly lower	Similar pricing with expansion potential
Mode of Action	VEGFR-2 inhibition	VEGF-A inhibition	VEGF-A & PlGF trapping	Specificity potentially leads to different efficacy profiles

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4. What Are the Future Market Opportunities and Challenges?

4.1. Opportunities

• Indication Expansion:
  Clinical trials in ovarian, pancreatic, and breast cancers hold promise.

• Combination Therapies:
  Synergies with immunotherapies such as PD-1/PD-L1 inhibitors can enhance efficacy.

• Biomarker Development:
  Stratifying patients improves response rates and market growth.

• Geographical Penetration:
  Collaborations in Asia-Pacific and Latin America can accelerate growth.

4.2. Challenges

• Biosimilar Entry:
  Biosimilar versions are under development, potentially reducing prices and market share post-patent expiry.

• Pricing and Reimbursement Pressures:
  Cost containment policies threaten revenue, especially in Europe and Asia.

• Competitive Landscape Evolution:
  Immunotherapy and targeted therapies offer alternative options, possibly reducing demand for VEGFR inhibitors.

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5. What Are the Key Strategic Considerations?

Strategy Element	Implication	Recommended Action
Pipeline Development	Sustains long-term growth	Invest in trials for new indications and combinations
Market Expansion	Diversifies revenue base	Focus on emerging markets with tailored pricing
Pricing Strategy	Maintains competitiveness	Explore value-based pricing and patient access programs
Patent Management	Protects market share	Secure early patent extensions and defend against biosimilar challenges

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Key Takeaways

• Ramucirumab's broad approval across multiple gastrointestinal and respiratory cancers positions it favorably within the biologic oncology market.
• Market growth hinges on indication expansion, combination therapies, and geographical penetration, with projected revenues reaching ~$2 billion by 2030.
• Competitive pressures from immunotherapies and biosimilars necessitate strategic innovation in indications, pricing, and collaborations.
• Ongoing clinical trials and biomarker-driven approaches will be critical in sustaining long-term growth and market relevance.
• Regulatory, reimbursement, and patent landscapes require continuous monitoring to mitigate risks and optimize market positioning.

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FAQs

Q1: When is ramucirumab expected to lose patent protection, and how will biosimilars impact its market?
A1: Patent protection is projected to expire between 2028 and 2030. Biosimilar competitors entering the market could reduce prices by 20-40%, squeezing margins and market share unless offset by indications expansion or combination therapies.

Q2: Which cancers are the next targets for ramucirumab clinical trials?
A2: Current studies focus on ovarian, pancreatic, and breast cancers, with several Phase II and III trials underway aiming to extend indications.

Q3: How does ramucirumab's efficacy compare to competing agents like bevacizumab?
A3: Both target VEGF pathways but differ in specific mechanisms—ramucirumab inhibits VEGFR-2, possibly offering a distinct efficacy and safety profile. Clinical trials indicate comparable or superior outcomes in specific settings, but head-to-head data remain limited.

Q4: What strategic collaborations could enhance ramucirumab's market position?
A4: Partnerships with biotech firms for novel combination regimens, regional distribution alliances, and academic collaborations in biomarker research present opportunities for market expansion.

Q5: How will reimbursement trends influence ramucirumab's market access?
A5: Favorable reimbursement policies in developed regions support growth; however, price controls and value-based reimbursement models could constrain margins, necessitating cost-effective treatment protocols.

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References

1. Eli Lilly and Company. (2014). FDA approves Cyramza for gastric or GE junction adenocarcinoma. [Press release].
2. National Cancer Institute. (2022). Ramucirumab Clinical Trials.
3. Pharmacoeconomics & Outcomes Research Journal. (2023). Biologic pricing and reimbursement trends.
4. FDA. (2019). Approval of ramucirumab for hepatocellular carcinoma.
5. EvaluatePharma. (2022). 2022 World Preview: Biologics Market Forecast.
6. WHO. (2021). Global Cancer Statistics.

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In conclusion, ramucirumab's evolving market dynamics are characterized by expansion across indications, geographies, and combination strategies, promising sustained growth despite competitive and pricing pressures. Strategic focus on pipeline development, market penetration, and cost management will be pivotal in realizing its full financial trajectory.