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Last Updated: December 25, 2024

ENTYVIO PEN Drug Profile


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Summary for Tradename: ENTYVIO PEN
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for ENTYVIO PEN
Mechanism of ActionIntegrin Receptor Antagonists
Established Pharmacologic ClassIntegrin 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 PEN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ENTYVIO PEN Derived from Company Disclosures

No patents found based on company disclosures

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

These patents were obtained by searching patent claims

ENTYVIO PEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ENTYVIO PEN

Introduction to ENTYVIO (Vedolizumab)

ENTYVIO, also known as vedolizumab, is a monoclonal antibody developed by Takeda Pharmaceuticals for the treatment of ulcerative colitis and Crohn’s disease. This biologic drug has been a significant player in the gastrointestinal disease treatment market, and its recent formulation as a pen has further enhanced its appeal.

Market Size and Growth

The global ENTYVIO market has been experiencing substantial growth. In 2022, the drug generated total sales of $5,364 million, representing a 20.8% increase from 2021. This growth is attributed to increased demand among patients suffering from inflammatory bowel disease (IBD)[4].

Geographic Distribution

The market performance of ENTYVIO varies significantly across different regions. The US holds the largest share, contributing approximately $3,704 million to the worldwide revenue in 2022. Europe and Canada also contribute substantially, with a combined share of $1,024 million. Emerging markets, though smaller, are growing and contributed around $278.52 million in 2022[4].

Technological Advancements and Formulations

The approval of the pen formulation for ENTYVIO marks a significant technological advancement. This subcutaneous form, approved based on the VISIBLE 2 phase 3 trial, has shown promising results in achieving long-term clinical remission for patients with Crohn’s disease. The trial demonstrated that 48% of patients receiving the subcutaneous ENTYVIO maintenance therapy achieved clinical remission at week 52, compared to 34% of patients receiving placebo[2].

Safety Profile

The safety profile of the subcutaneous ENTYVIO formulation is generally consistent with the intravenous form, with additional adverse events related to injection site reactions such as erythema, rash, and swelling[2].

Consumer Behavior and Personalization

There is a growing trend towards customization and personalization in the healthcare industry, including the ENTYVIO market. Patients are seeking treatments tailored to their unique needs and preferences. The introduction of the pen formulation caters to this demand by offering a more convenient and patient-friendly administration method.

Expansion into Emerging Markets

Companies are increasingly focusing on expanding their presence in emerging markets. These regions offer significant growth potential due to rising disposable incomes, urbanization, and a growing middle class. ENTYVIO’s presence in these markets is expected to drive substantial revenue growth as more patients gain access to this treatment[1].

Sustainability and Corporate Responsibility

Sustainability and corporate social responsibility (CSR) are becoming critical components of the pharmaceutical industry. Companies that prioritize sustainable practices and ethical governance are enhancing their brand reputation and customer loyalty. Takeda Pharmaceuticals, the manufacturer of ENTYVIO, is likely to benefit from these initiatives as consumers and stakeholders place greater emphasis on environmental and social governance (ESG) factors[1].

Enhanced Consumer Engagement

The ENTYVIO market is witnessing a paradigm shift in consumer engagement strategies. Digital platforms, social media, and interactive technologies are being leveraged to connect with patients more effectively. This enhanced engagement leads to better patient experiences, higher satisfaction levels, and increased brand loyalty[1].

Financial Trajectory

Revenue and Sales

ENTYVIO has been a top-performing drug for Takeda Pharmaceuticals, contributing significantly to the company’s overall revenue. The drug’s annual sales have grown substantially, with a notable 20.8% increase in 2022 compared to 2021. This growth is expected to continue as the demand for IBD treatments increases globally[4].

Cost and Pricing

The cost of ENTYVIO can vary based on several factors, including insurance coverage, treatment plans, and geographic location. The wholesale acquisition cost for two pens of the subcutaneous formulation is $6,239.94. However, various savings programs and co-pay assistance are available to help patients manage the cost. For example, the ENTYVIO Co-Pay Program offers up to $20,000 in annual benefits for medication costs, although this can be reduced to $9,000 if the patient’s insurance plan implements a co-pay maximizer program[3][5].

Economic Impact

The economic impact of ENTYVIO is significant, not only for Takeda Pharmaceuticals but also for the broader healthcare market. The drug’s high price, while a challenge for some patients, reflects the extensive research and development costs associated with biologic drugs. The lack of biosimilar versions for ENTYVIO currently means that the drug remains a high-cost option, although this could change once the patent expires and biosimilars enter the market[3].

Key Drivers of Growth

Rising Consumer Awareness and Expectations

Today’s consumers are more informed and have higher expectations, demanding quality, transparency, and value. ENTYVIO’s ability to meet these expectations through its efficacy and convenience has contributed to its market success[1].

Economic Growth and Rising Incomes

Global economic growth and rising disposable incomes, particularly in developing regions, are driving the expansion of the ENTYVIO market. As consumers’ purchasing power increases, so does their ability to spend on advanced treatments like ENTYVIO[1].

Strategic Collaborations and Partnerships

Companies are forming strategic alliances and partnerships to expand their capabilities and reach. These collaborations can enable businesses to leverage each other’s strengths, access new technologies, and enter new markets more effectively, further driving the growth of the ENTYVIO market[1].

Challenges and Considerations

Regulatory and Pricing Pressures

ENTYVIO, like other biologic drugs, faces regulatory and pricing pressures. For instance, the Institute for Clinical and Economic Review (ICER) has identified ENTYVIO among drugs with price increases not supported by new clinical evidence, which can impact its market dynamics[2].

Competition from Future Biosimilars

Although ENTYVIO does not currently have biosimilar versions, the eventual entry of biosimilars into the market could reduce its market share and pricing power. Biosimilars, being similar to biologic drugs but requiring less costly testing, tend to be more affordable and could attract price-sensitive consumers[3].

Key Takeaways

  • Market Growth: ENTYVIO has seen significant growth, driven by increased demand for IBD treatments and the introduction of a more convenient pen formulation.
  • Geographic Distribution: The US is the largest market for ENTYVIO, followed by Europe and Canada, with emerging markets showing potential for future growth.
  • Technological Advancements: The subcutaneous pen formulation has enhanced patient convenience and efficacy.
  • Financial Trajectory: ENTYVIO is a top-performing drug for Takeda Pharmaceuticals, with substantial revenue growth expected to continue.
  • Consumer Engagement: Enhanced digital engagement strategies are improving patient experiences and brand loyalty.
  • Challenges: Regulatory pressures, pricing scrutiny, and the potential entry of biosimilars are key challenges to consider.

FAQs

Q: What is ENTYVIO used for?

ENTYVIO (vedolizumab) is used for the treatment of ulcerative colitis and Crohn’s disease, both forms of inflammatory bowel disease (IBD).

Q: What is the new formulation of ENTYVIO?

The new formulation of ENTYVIO is a single-dose prefilled pen for subcutaneous administration, approved for the treatment of Crohn’s disease.

Q: How much does ENTYVIO cost?

The cost of ENTYVIO can vary based on insurance coverage and other factors. The wholesale acquisition cost for two pens is $6,239.94, but savings programs and co-pay assistance are available.

Q: What are the key drivers of ENTYVIO's market growth?

Key drivers include rising consumer awareness and expectations, economic growth and rising incomes, and strategic collaborations and partnerships.

Q: Are there any biosimilar versions of ENTYVIO available?

Currently, there are no biosimilar versions of ENTYVIO available, but this could change once the patent expires.

Sources

  1. Global Entyvio (vedolizumab) Drug Market Overview [2024-2032] - Southeast News Channel Nebraska
  2. FDA Approves Pen Form of Entyvio for Crohn's Disease - Managed Healthcare Executive
  3. Entyvio cost: Savings options and more - Medical News Today
  4. Top Performing Drug – Entyvio (February Edition) - PharmaShots
  5. ENTYVIO® (vedolizumab) Patient Support - Entyviohcp.com

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