Ziv-aflibercept - Biologic Drug Details

Summary for ziv-aflibercept

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

Recent Clinical Trials for ziv-aflibercept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sahiwal medical college sahiwal	PHASE4
Ahmad Zeeshan Jamil	PHASE4
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	PHASE4

See all ziv-aflibercept clinical trials

Pharmacology for ziv-aflibercept

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

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 ziv-aflibercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ziv-aflibercept 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
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2036-11-18	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2038-03-20	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2024-05-04	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2023-06-30	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2024-06-29	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2023-02-10	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2027-06-25	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ziv-aflibercept 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
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2037-06-22	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2037-02-13	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2036-07-08	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2037-02-03	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2037-01-18	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2035-09-10	Patent claims search
Sanofi-aventis U.s. Llc	ZALTRAP	ziv-aflibercept	Injection	125418		2035-11-24	Patent claims search

International Patents for ziv-aflibercept

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011040565
China	109535228
China	109535259
European Patent Office	2600889
Russian Federation	2015122368
Japan	2016504309
Japan	6400810

Ziv-aflibercept Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Ziv-aflibercept?

Ziv-aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor (VEGF) pathways, primarily used in cancer therapy. It is marketed under the brand name Zaltrap by Sanofi and Regeneron Pharmaceuticals. Its market environment is shaped by competition, regulatory status, patent landscape, and clinical penetration.

Therapeutic Usage and Competitive Position

Ziv-aflibercept is approved for metastatic colorectal cancer (mCRC) refractory to chemotherapy. It competes primarily with other anti-VEGF agents, such as bevacizumab, aflibercept (Eylea, sold for eye conditions but structurally similar), and ramucirumab. Its therapeutic positioning as a second-line treatment lends stability but limits future market expansion.

Market Penetration and Adoption

The drug's sales depend on its adoption in oncology practices across the US, Europe, and Asia. As of 2022, its market share in second-line mCRC has remained modest, partly due to preferences for established therapies and cost considerations. The drug’s use is constrained by its side-effect profile and the presence of alternative agents with broader approvals.

Regulatory and Patent Constraints

Ziv-aflibercept benefits from patent exclusivity extending into the late 2020s in key markets. However, biosimilar and generic competition looms on expiration, threatening future sales. Regulatory restrictions in certain geographies hinder widespread use; for example, approvals are limited outside oncology.

Pricing and Reimbursement Dynamics

Pricing strategies for ziv-aflibercept are consistent with biologics, often exceeding $5,000 per dose. Reimbursement depends on payer policies, which are increasingly scrutinized for cost-effectiveness. The marginal margins are squeezed as payers push for value-based pricing.

External Market Drivers

Growing global cancer incidence boosts the total addressable market. The expansion of combination regimens and biomarker-driven therapy selection could influence uptake. However, the COVID-19 pandemic has disrupted routine oncology treatments, causing temporary sales declines.

What Is the Financial Trajectory of Ziv-aflibercept?

Revenue Performance

Sanofi's reported global sales of Zaltrap fluctuated around $150 million to $200 million annually from 2017 to 2022. The trend has been downward, reflecting slow growth, limited market penetration, and increasing competition.

Cost Structure and Profitability

Manufacturing costs for biologics are high, but scale efficiencies reduce unit costs over time. Marketing expenses are relatively moderate, focusing on key markets. Operating margins for the product are narrow due to competitive pricing pressures.

Future Revenue Potential

Projection models suggest revenues could decline by 10-15% annually over the next five years without significant clinical or regulatory breakthroughs. The expiration of patents and the entry of biosimilars are expected to accelerate revenue decline from 2025 onwards.

Impact of Biosimilars

Expected biosimilar entry by 2024-2025 could slash prices by 30-50%, depending on market penetration and regulatory acceptance. Competitive pressure from biosimilars typically reduces original biologic sales by 20-40% within two years of market entry.

Long-Term Outlook

Ziv-aflibercept's financial viability relies heavily on its positioning against biosimilars, potential new indications, and combination therapies. Investment in pipeline development or label extensions could stabilize or extend revenue streams, but no major approvals are imminent.

How Do Market and Financial Factors Interact?

The biologic’s slow market growth and impending patent expiry limit revenue growth. Competitive pressures from biosimilars and alternative therapies threaten profitability. Cost containment becomes critical as margins shrink. The product might remain a niche player unless new indications, combination strategies, or market expansion occur.

Key Takeaways

• Ziv-aflibercept holds a niche role in second-line metastatic colorectal cancer, facing limited growth prospects.
• Sales peaked around 2017-2018 and declined slightly thereafter due to market saturation and competition.
• Patent expiry and biosimilar development threaten future revenue, with potential decreases of 30-50% in market share upon biosimilar entry.
• Revenues are estimated to decline by 10-15% annually in the coming years unless market dynamics shift.
• Cost management and pipeline innovation are essential for maintaining profitability.

FAQs

1. What factors limit ziv-aflibercept's market growth?
   Competition from other anti-VEGF agents, limited approved indications, and payer reimbursement challenges restrict expansion.

2. When will biosimilars likely impact the ziv-aflibercept market?
   Biosimilars are expected to enter around 2024-2025, which could substantially reduce branded drug sales.

3. Can ziv-aflibercept be used for other indications?
   Current approvals are limited to metastatic colorectal cancer; further indications are in early development or not pursued.

4. How does pricing compare to similar biologics?
   Zaltrap’s per-dose cost exceeds $5,000, comparable to other anti-VEGF biologics but with narrower approved uses.

5. What is the outlook for future investments in ziv-aflibercept?
   Without new indications or significant label extensions, future investments will likely focus on biosimilar development and market share preservation strategies.

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References
[1] Regeneron Pharmaceuticals. "Zaltrap (ziv-aflibercept) Prescribing Information." 2022.
[2] Sanofi. "Zaltrap Revenue Reports." 2017-2022.
[3] EvaluatePharma. "Biologic Market Trends," 2022.
[4] FDA. "Approved Cancer Therapeutics," 2022.
[5] IQVIA Institute. "Global Oncology Market Analysis," 2022.