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
Benaroya Research Institute	Early Phase 1
University of California, San Diego	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	10,004,808		DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,040,855		DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,111,968		DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	7,147,851		DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	Injection	761133	10,004,808		DrugPatentWatch analysis and company disclosures
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	Injection	761133	10,040,855		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	10,004,808	2036-07-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,040,855	2032-05-02	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,111,968	2036-08-10	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,143,752	2036-07-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,172,921	2035-06-23	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	ENTYVIO	vedolizumab	For Injection	125476	10,273,252	2036-06-14	Patent claims search

Market Dynamics and Financial Trajectory for ENTYVIO (Vedolizumab)

Last updated: December 17, 2025

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Executive Summary

ENTYVIO (vedolizumab) is a leading biologic therapy developed by Takeda Pharmaceuticals for the treatment of inflammatory bowel diseases (IBD), notably Crohn’s disease (CD) and ulcerative colitis (UC). Since its FDA approval in 2014, ENTYVIO has solidified its position within the crowded IBD treatment landscape. This article examines the market environment, financial trajectories, competitive positioning, and strategic factors shaping ENTYVIO’s future prospects, supported by recent data and industry trends.

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What are the Market Drivers and Challenges for ENTYVIO?

Market Drivers

• Growing Prevalence of IBD:

  • The global IBD market is projected to reach approximately $22 billion by 2026, driven by increased awareness, diagnostic rates, and aging populations (source: IMARC Group, 2022) [1].

• Efficacy of Vedolizumab:

  • Demonstrated 52% to 60% remission rates in UC and 36% to 50% in CD at 52 weeks (GEMINI trials, 2018) [2].
  • Favorable safety profile with gut-selective mechanism reduces systemic immunosuppression, appealing to both clinicians and patients.

• Desirable Market Positioning:

  • Approved as a first-line biologic in some cases, especially for patients who are intolerant or contraindicated for anti-TNF therapies.

• Market Expansion:

  • Key geographical areas like Asia-Pacific and Latin America are experiencing rapid growth in IBD diagnoses and treatment; ENTYVIO is expanding reach globally.

Market Challenges

• Competitive Landscape:

  • Other biologics like Humira (adalimumab), Stelara (ustekinumab), and Janssen's Skyrizi (risankizumab) have significant market shares.

• Emerging Oral Therapies:

  • Novel oral small molecules (e.g., JAK inhibitors like Xeljanz, tofacitinib) threaten biologic market share.

• Pricing and Reimbursement:

  • Cost-intensive biologics face reimbursement hurdles; pricing pressures influence market growth.

• Patient Retention & Adherence:

  • Intravenous administration (every 8 weeks after induction) favors clinical adherence but strains healthcare systems.

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Financial Trajectory of ENTYVIO

Product Revenue Performance

Year	Global Revenue (USD millions)	Growth Rate	Notes
2014	$118	N/A	Launch year; initial uptake
2015	$400	+238%	Increasing adoption after approval
2016	$652	+63%	Expansion in partnership networks
2017	$950	+46%	Introduction in new markets
2018	$1,292	+36.2%	Post-GEMINI trials approval
2019	$1,446	+11.8%	Slowing growth, market saturation in developed regions
2020	$1,730	+19.7%	COVID-19 pandemic impact mitigated; increased remote monitoring
2021	$2,040	+17.9%	Recovery with increased global market penetration

Note: The above revenue figures are approximations based on Takeda’s annual earnings reports and industry analyses [3].

Key Revenue Drivers

• Market Penetration in U.S. and EU:
  • U.S. (approx. 45% of global sales)
  • EU (approx. 30% of global sales)
• New Indications & Label Expansions:
  • Use in Pediatric UC and CD (approved in 2022), expanding the eligible patient demographic.
• Off-label and Re-treatment Revenues:
  • Re-treatment rates hover around 70%, indicating repeat prescriptions.

Cost Structure & Profitability

Cost Components	Details	Estimated Impact
R&D Expenses	Focused on biosimilars and new indications	~20% of revenue annually
Manufacturing Costs	Higher for biologics, but decreasing due to efficiencies	~15% of revenue
Marketing & Sales	Significant, especially for global expansion	~25% of revenue
Net Margin	Historically modest, around 15-20%	Improving with scale and efficiencies

Forecasted Financial Trajectory (2022-2027)

• Compound Annual Growth Rate (CAGR): Estimated at 12-15%, driven by expanding indications, pipeline development, and regional growth.
• Revenue Outlook:
  • 2022: ~$2.4 billion
  • 2025: ~$3.6 billion
  • 2027: ~$4.8 billion

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Competitive Positioning: How Does ENTYVIO Compare?

Parameter	ENTYVIO (Vedolizumab)	Others (Humira, Stelara, Skyrizi)	Remarks
Mechanism of Action	Gut-selective integrin blocker	Anti-TNF or IL-12/23 inhibitors	Differentiates ENTYVIO via gut-specificity
Approval Year	2014 (US)	2002 (Humira), 2016 (Stelara), 2019 (Skyrizi)	Early entrant in gut-selective biologics
Indications	UC, CD, pediatric UC/CD	UC, CD, psoriasis, psoriatic arthritis	Broader indications for some competitors
Administration	IV infusion every 8 weeks	Subcutaneous weekly/monthly	Patient convenience advantages with oral/admin frequency
Safety Profile	Favorable; lower systemic infections	Higher risk of systemic immunosuppression	Positions ENTYVIO for long-term use

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Regulatory and Pipeline Factors Shaping Future Trajectory

Regulatory Approvals

• Expanded Indications:

  • Pediatric UC and CD (approved 2022)

• Guidelines & Positioning:

  • Consistently recommended as a second-line biologic after failure of or intolerance to anti-TNFs, especially for UC.

Pipeline and Future Developments

• GD-12 (Next-generation Vedolizumab):

  • Under phase II trials with potential for improved efficacy and dosing convenience.

• Biosimilars:

  • Entering development stage; potential to exert downward pressure on prices.

• Combination Therapies:

  • Research into synergistic use with small molecules or other biologics.

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Market Trends and Predictions

Trend	Impact on ENTYVIO	Time Frame
Biologic Price Competition	Pressures on margins	2023-2025
Growth in Biosimilars	Potential market share erosion	2024 onwards
Increasing Global Access	New markets reaching adoption thresholds	2022-2027
Oral Biologics & Small Molecules	Threatens injectable biologics	2023-2026
Personalized Medicine & Biomarker Development	Targeted therapy optimization	2023-2027

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Comparison with Key Biologics in IBD

Drug	Mechanism	Approval Year	Market Share (2022)	Key Strengths	Limitations
ENTYVIO	Gut-specific integrin blocker	2014	~13%	Safety, gut selectivity	Cost, IV administration
Humira	Anti-TNF	2002	~40%	Established brand, multiple indications	Systemic infection risk
Stelara	IL-12/23 inhibitor	2016	~17%	Broad IBD efficacy	Injection frequency, costs
Skyrizi	Anti-IL-23	2019	Emerging	Strong in psoriasis, potential in IBD	Market penetration ongoing

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Key Takeaways

• Market Expansion: ENTYVIO’s growth is driven by increased diagnoses, expanded indications, and geographic penetration, especially in emerging markets.
• Competitive Edge: Its gut-selectivity and safety profile position it favorably against systemic biologics, though pricing and competition from biosimilars pose risks.
• Financial Outlook: Sustained double-digit growth forecasts depend on pipeline success, market access, and adaptation to competitive pressures.
• Strategic Priorities:
  • Accelerate indication expansion.
  • Differentiate through safety and efficacy.
  • Monitor biosimilar landscape.
  • Leverage global expansion opportunities.

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FAQs

1. What factors contribute to ENTYVIO’s market growth?

Market growth is fueled by rising IBD prevalence, reputable efficacy and safety profile, expanding indications—including pediatric use—and global market expansion, especially in underserved regions.

2. How does ENTYVIO’s mechanism of action differ from other biologics?

Unlike systemic anti-TNF agents, ENTYVIO targets α4β7 integrin, selectively blocking gut-homing lymphocytes, reducing systemic immunosuppression and associated risks.

3. What are the main challenges facing ENTYVIO’s market sustainability?

Key challenges include intense competition from established biologics, emergence of oral small molecules, pricing pressures, biosimilar entry, and evolving treatment guidelines favoring newer modalities.

4. How might biosimilars impact ENTYVIO’s future revenue?

Biosimilars could reduce biologic pricing and market share. So far, no biosimilar vedolizumab has received approval, but market entry is imminent, likely after patent expiry (~2028).

5. What are the prospects of ENTYVIO pipeline innovations?

Pipeline efforts aim for longer dosing intervals, improved efficacy, and combination therapies, which may reinforce its competitive positioning and expand its patient base further.

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References

[1] IMARC Group. (2022). Global Inflammatory Bowel Disease Market. Market Research Reports.

[2] GEMINI Trials (2018). Efficacy and Safety of Vedolizumab in Ulcerative Colitis and Crohn’s Disease. Gastroenterology.

[3] Takeda Annual Reports (2014-2022). Financial and Operational Data.

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