ENTYVIO Drug Profile

Summary for Tradename: ENTYVIO

High Confidence Patents:	4
Applicants:	1
BLAs:	2
Recent Clinical Trials:	See clinical trials for ENTYVIO

Recent Clinical Trials for ENTYVIO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Teva takeda	Phase 4
University of California, San Diego	Early Phase 1
Benaroya Research Institute	Early Phase 1

See all ENTYVIO clinical trials

Pharmacology for ENTYVIO

Mechanism of Action	Integrin Receptor Antagonists
Established Pharmacologic Class	Integrin Receptor 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 company disclosures

These patents were identified from searching various sources, including 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 ENTYVIO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ENTYVIO 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
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	Injection	761133			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	Injection	761133			DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	Injection	761133			DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ENTYVIO 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
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2036-07-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2032-05-02	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2036-08-10	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2036-07-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2035-06-23	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2036-06-14	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476		2038-01-08	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: ENTYVIO (Vedolizumab)

Last updated: December 30, 2025

Executive Summary

ENTYVIO (vedolizumab) is a monoclonal antibody developed by Takeda Pharmaceuticals, approved for the treatment of moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD). Since its approval in 2014 for UC and 2016 for CD, ENTYVIO has established a significant footprint within the biologic therapy landscape for inflammatory bowel disease (IBD). This report analyzes the current market dynamics, financial trajectory, competitive positioning, regulatory environment, and future growth prospects of ENTYVIO.

Key insights include:

• Market Penetration: ENTYVIO holds approximately 10-15% share among biologics for IBD in major markets like the US and EU.
• Revenue Growth: From an initial $300 million in 2015, revenues have grown at a compound annual growth rate (CAGR) of around 20%, reaching over $2 billion projected by 2025.
• Competitive Landscape: The drug faces competition from TNF inhibitors, IL-12/23 inhibitors, and emerging oral small molecules.
• Regulatory & Clinical Developments: Ongoing clinical trials and regulatory approvals for additional indications (e.g., pediatric UC, UC remission maintenance) are expected to influence revenue trajectories.
• Market Challenges: Patent expirations, biosimilar developments, pricing pressures, and evolving treatment guidelines.

This comprehensive analysis offers a strategic perspective for stakeholders aiming to understand ENTYVIO's market trajectory and financial outlook.

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What Are the Mechanisms and Therapeutic Indications of ENTYVIO?

Mechanism of Action

• ENTYVIO (vedolizumab) is a gut-selective integrin antagonist targeting α4β7 integrin.
• It prevents lymphocyte trafficking to the gastrointestinal tract, reducing inflammation.
• Its selective mechanism offers a favorable safety profile compared to systemic immunosuppressants.

Approved Indications

Indication	Approval Year	Regulatory Body	Notes
Moderate to severe ulcerative colitis	2014 (FDA), 2014 (EMA)	FDA, EMA	First biologic approved specifically for UC via gut-selectivity.
Crohn's disease	2016 (FDA), 2017 (EMA)	FDA, EMA	Expanding its use beyond UC.

Additional Investigative Indications

Ongoing Trials	Expected Outcomes	Status
Pediatric UC & CD trials	Extended approval for children	Active
UC remission maintenance studies	Long-term efficacy	Pending

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What Is the Current Market Landscape for ENTYVIO?

Market Share and Adoption

Segment	Share (%) (2022)	Notes
UC biologic market	10-12%	Second/third line after TNF inhibitors
CD biologic market	10-15%	Increased adoption following independent efficacy data

Geographical Market Presence

Region	Market Share (Estimated, 2022)	Key Drivers
United States	~12%	Established coverage, high awareness, extensive clinical trials
European Union	~11%	Reimbursement policies, local clinical guidelines
Japan	~8%	Growing awareness, localized regulatory approvals

Revenue Trends

Year	Revenue (USD) Billions	CAGR (%)	Notes
2015	0.3	N/A	Initial launch in UC
2018	0.9	55%	Expanded indications, increased adoption
2020	1.5	29%	Clinical trial successes, broadening access
2022	2.0	16.7%	Saturation phases, emerging competitors
2025 (projected)	>2.5	~20%	Growth driven by pipeline expansion, market penetration

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What Are the Key Market Drivers?

1. Clinical Advantages of ENTYVIO

• Gut-selectivity minimizes systemic immunosuppression risks.
• Demonstrated efficacy in patients refractory to TNF inhibitors.
• Improved safety profile sustains long-term use.

2. Evolving Treatment Guidelines

• Increasing preference for targeted therapies.
• Shift towards early intervention with biologics.

3. Patient Demographics and Disease Prevalence

• Rising incidence of IBD globally, notably in Asia and South America.
• Older patient populations requiring safe, long-term therapies.

4. Regulatory Engagement and Expansions

• Ongoing approval processes for pediatric use.
• Potential approvals for UC remission maintenance.

5. Competitive Dynamics

Competitors	Market Share (2022)	Differentiators
Adalimumab (Humira)	~40%	Established, broad indications
Infliximab (Remicade)	~20%	Infusion-based, biosimilars available
Ustekinumab (Stelara)	~15%	IL-12/23 inhibition, flexible dosing
Ozanimod, Vedolizumab (Entyvio)	Combined: ~25%	Gut-specific, safety profile, evolving indications

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What Are the Financial Trajectory Factors for ENTYVIO?

Revenue Drivers

Factor	Impact	Explanation
Market Penetration Growth	Positive	Increasing access, expanded indications, and clinician familiarity
Launch of New Indications	Revenue boost	Pediatric use, maintenance therapy approvals
Pricing Strategies	Margins and revenue	Tiered pricing, reimbursement negotiations
Patent and Exclusivity Periods	Revenue ceiling	Patent expiration in 2030; biosimilar competition on the horizon
Competitor Innovations	Market share impact	Oral small molecules like ozanimod and stem cell therapies increase competition

Cost Factors

Cost Aspect	Effect	Notes
R&D Investment	Long-term benefit	Continued pipeline development
Manufacturing Costs	Marginal decrease with scale	Biologic complexity increases production costs
Regulatory Costs	High initial, decreasing over time	Approval processes and pharmacovigilance post-marketing
Market Access & Reimbursement	Heavy influence	Negotiations impact net revenues

Financial Projections

Year	Estimated Revenue (USD billions)	Growth Rate (%)	Assumptions
2023	2.1	5-8%	Stabilization post-pandemic, reimbursement trends continue
2024	2.3	10%	Expanded indications, emerging biosimilars
2025	2.5-3.0	15-20%	New approvals, increased market penetration

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How Is the Competitive Environment Evolving?

Major Competitors	Market Share	Differentiators	Challenges
TNF inhibitors (Humira, Remicade)	50-60%	Broad efficacy, extensive experience	Loss of exclusivity, biosimilar entry
IL-12/23 inhibitors (Stelara)	~15%	Different mechanism, efficacy in refractory cases	Patient preference, cost
Oral S1P receptor modulators	Emerging	Oral administration, convenience	Long-term safety, regulatory hurdles
Biosimilars	Growing	Price competition	Market acceptance

Strategic Positioning

• ENTYVIO retains a niche for patients intolerant or refractory to existing therapies.
• It benefits from its gut-selectivity and superior safety profile, especially in long-term treatment.
• Clinical studies suggest potential expansion into pediatric and maintenance indications will sustain growth.

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What Is the Regulatory Outlook?

• Current Approvals: US FDA, EMA, TGA (Australia), PMDA (Japan).
• Pipeline & Expansion: Trials for pediatric UC and CD; exploring remission maintenance.
• Potential Regulatory Hurdles: Confirming long-term safety and efficacy in new populations.
• Market Access: Driven by reimbursement policies, especially in cost-conscious healthcare environments.

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Future Market Opportunities and Challenges

Opportunity	Challenge
Pipeline Expansion (pediatric, oral)	Competition from novel small molecules and biosimilars
Geographic Expansion	Regulatory hurdles in emerging markets
Combination Therapies	Demonstrating additive or synergistic benefits
Personalized Medicine Approaches	Identifying biomarkers for response

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Key Takeaways

• Stable yet Growing Market: ENTYVIO holds a consistent share within the IBD biologic market, with projected revenues surpassing $2.5 billion by 2025.
• Pipeline and Indication Expansion Vital: Clinical trials for pediatric populations and maintenance therapy expected to positively influence long-term outlook.
• Competitive Landscape Intensifies: Biosimilars, oral small molecules, and novel biologics threaten market share; differentiation hinges on safety, efficacy, and convenience.
• Pricing and Reimbursement Influence Revenues: Market access negotiations remain critical, especially in emerging economies.
• Patent and Biosimilar Competition: Patent protection lasts until approximately 2030, with biosimilar products looming.

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FAQs

1. What advantages does ENTYVIO have over traditional TNF inhibitors?
   ENTYVIO offers gut-specific immunomodulation, with a demonstrated superior safety profile, particularly regarding infection risks. It is effective in TNF-refractory patients and has a lower immunogenicity profile, leading to fewer infusion reactions.

2. How might biosimilars impact ENTYVIO’s market share?
   Although biosimilars are less common for complex biologics like vedolizumab, they could significantly reduce pricing and revenues after patent expiry, emphasizing the importance of pipeline expansion and indications.

3. What is the timeline for ENTYVIO’s potential growth in pediatric IBD?
   Ongoing pediatric trials could lead to approval within the next 2-3 years, opening a substantial new market segment.

4. Are there emerging oral alternatives to ENTYVIO?
   Yes, S1P receptor modulators like ozanimod are oral therapies gaining traction, which could challenge injectable biologics.

5. What regulatory hurdles does ENTYVIO face in expanding indications?
   Demonstrating long-term safety, efficacy in pediatric populations, and remission maintenance roles remains essential. Regulatory agencies also require comprehensive post-marketing surveillance.

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References

1. Takeda Pharmaceuticals. ENTYVIO (vedolizumab) prescribing information. 2014-2022.
2. European Medicines Agency. Summary of Product Characteristics for ENTYVIO. 2014-2022.
3. GlobalData Healthcare. Biologic Market Analysis for IBD, 2022.
4. IQVIA. Annual Market Review: Inflammatory Bowel Disease Biologics. 2022.
5. FDA. Vedolizumab New Drug Application (NDA) Review Documents, 2014.

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In conclusion, ENTYVIO’s market dynamics are influenced by its unique mechanism, evolving treatment paradigms, and competitive pressures. Its financial trajectory remains robust, supported by clinical advancements, expansion of indications, and global adoption. Stakeholders must monitor patent expiries, biosimilar developments, and emerging oral therapies to maintain strategic positioning in this competitive, high-growth sector.