Last updated: February 13, 2026
What Is NDC 00597-0075?
NDC 00597-0075 corresponds to Entyvio (vedolizumab), a monoclonal antibody approved for the treatment of ulcerative colitis and Crohn’s disease. Manufactured by Takeda Pharmaceuticals, Entyvio received FDA approval in 2014. It functions by blocking the integrin α4β7, preventing gut-specific lymphocyte trafficking.
Market Overview
Indications and Patient Population
- Approved for moderate to severe ulcerative colitis and Crohn’s disease.
- U.S. prevalence estimates suggest approximately 1.3 million people with inflammatory bowel disease (IBD).
- Approximately 1 million patients with Crohn's disease and 900,000 with ulcerative colitis in the U.S. are potential candidates.
Competitive Landscape
- Key competitors include infliximab (Remicade), adalimumab (Humira), ustekinumab (Stelara), and ozanimod (Zeposia).
- Entyvio's niche is among patients refractory to or intolerant of anti-TNF therapies or those seeking gut-specific treatment with fewer systemic side effects.
- Market share trends favor newer agents like ustekinumab and ozanimod, which add to the competitive pressure.
Market Penetration & Growth
- As of 2022, Entyvio's U.S. market share of IBD biologics approximates 7–9%, with sales reaching around $1.1 billion.
- The drug's growth rate has slightly decelerated due to increased competition and pipeline developments but remains steady amid new formulary placements.
Regulatory and Payer Dynamics
- National and regional formularies increasingly favor cost-effective, highly effective options.
- U.S. average list price for Entyvio is approximately $6,300 per dose, with typical dosing of 300 mg (two 150 mg IV infusions at weeks 0, 2, 6, then every 8 weeks).
- Patient access depends on insurance formulary status, copay assistance programs, and prescribing trends.
Price Trends and Projections
| Year |
Sales (USD billions) |
Average Price per Dose |
Number of Patients |
Notes |
| 2020 |
1.01 |
$6,300 |
~115,000 |
Stable market penetration |
| 2021 |
1.07 |
$6,300 |
~120,000 |
Slight growth driven by new diagnoses |
| 2022 |
1.12 |
$6,350 |
~125,000 |
Market expansion, competition persists |
Factors Influencing Price and Revenue
- Price Volume Relationship: Price per dose remains stable; growth attributed primarily to increased patient access.
- Market Expansion: New indications (e.g., ulcerative colitis maintenance in adults) approved in 2019 may contribute to revenue tailwinds.
- Pricing Pressures: Proposal of value-based agreements and biosimilar competition could pressure pricing in the future.
Future Price and Revenue Projections (2023–2027)
Predictions assume steady market growth, limited biosimilar competition (as of early 2023, biosimilars are not yet marketed for vedolizumab in the U.S.), and an estimated annual growth rate of 4%.
| Year |
Estimated U.S. Sales (USD billions) |
Market Share |
Key Assumptions |
| 2023 |
1.16 |
7.5% |
Patent exclusivity continues, stable patient access |
| 2024 |
1.21 |
8.0% |
Slight increase in adoption due to pipeline expansion |
| 2025 |
1.27 |
8.0–8.5% |
Market saturation limits growth; biosimilars unlikely before 2026 |
| 2026 |
1.33 |
8.5% |
Biosortal (biosimilar entrants) anticipated, bearish impact possible |
| 2027 |
1.36 |
~9% |
Market stabilization, price competition expected |
Risks and Competition Impact
- Biosimilars: Entry could erode profit margins and reduce prices; biosimilar development for vedolizumab is underway outside the U.S.
- Pipeline Alternatives: New oral agents and small molecule therapies expanding treatment options could dilute market share.
- Regulatory Changes: Pricing reforms or formulary restrictions may influence revenue trajectories.
Key Takeaways
- Entyvio maintains a stable revenue stream with incremental growth driven by increasing patient access.
- Pricing remains relatively stable at ~$6,300 per dose, with potential downward pressure from biosimilar competition after 2025.
- Market share growth depends on the drug's positioning amid emerging therapies and market dynamics.
- Future revenue projections suggest a compound annual growth rate (CAGR) of approximately 4%, reaching $1.36 billion by 2027, barring major shifts in patent rights or biosimilar entry.
- Market access strategies, including payer negotiations and patient assistance programs, will influence actual pricing and sales.
FAQs
1. When will biosimilars for vedolizumab enter the U.S. market?
Projected biosimilar entry is likely post-2025, contingent on FDA approvals and biosimilar manufacturer timelines.
2. How does Entyvio compare to other biologics in terms of efficacy?
Clinical trials show comparable efficacy with other IBD biologics. Entyvio's gut-selective mechanism often results in fewer systemic side effects.
3. What pricing pressures could affect future sales?
Introduction of biosimilars, value-based pricing negotiations, and legislative reforms could reduce list prices and reimbursement rates.
4. Are there new indications that could expand Entyvio's market?
Recent approvals include ulcerative colitis maintenance; ongoing trials could support additional uses, expanding eligible patients.
5. How is patient access impacted by insurance?
Coverage varies; copay assistance and formulary placement influence accessibility. The drug remains generally accessible in major commercial plans.
References
- [1] FDA. "Entyvio (vedolizumab) Prescribing Information." 2014.
- [2] IQVIA. "Biologic Sales Trends," 2022.
- [3] Takeda Pharmaceuticals. "Entyvio Overview." 2022.
- [4] MarketWatch. "Biological Drugs in IBD Market," 2022.
- [5] FDA. "Biosimilar Development Programs," 2023.
