Last updated: March 8, 2026
What is NDC 50268-0748?
NDC 50268-0748 corresponds to Entyvio (vedolizumab), a biologic agent approved by the FDA for the treatment of ulcerative colitis and Crohn's disease. It is a monoclonal antibody designed to inhibit the alpha4beta7 integrin, reducing gut-specific inflammation.
Current Market Landscape
Market Size
- The global inflammatory bowel disease (IBD) market, which includes ulcerative colitis and Crohn’s disease, was valued at approximately $7.2 billion in 2022.
- US market share constitutes roughly 55% of the global market, equating to $4 billion.
- The prevalence in the US is estimated at 1.3 million patients with IBD.
Competitive Profile
- Main competitors include Humira (adalimumab), Cimzia (certolizumab pegol), Stelara (ustekinumab), and Remicade (infliximab).
- Vedolizumab's market share is growing, driven by its gut-specific mechanism and lower systemic immunosuppression risks.
- As of 2022, Vedolizumab accounts for approximately 8% of the IBD biologic market in the US.
Treatment Trends
- Overall biologic usage for IBD is increasing annually at approximately 6-8%.
- The transition to biosimilars and newer agents slightly impacts revenue but vedolizumab retains premium positioning due to its safety profile.
- Infusion-based administration limits competition from some oral agents.
Price Analysis
Current Pricing
- The average wholesale price (AWP) per dose of Entyvio (300 mg intravenous infusion) is approximately $6,200.
- Patients typically receive an induction regimen of 300 mg at weeks 0, 2, and 6, then maintenance doses every 8 weeks.
- Treatment costs can reach approximately $40,000–$45,000 annually per patient.
Historical Price Trends
| Year |
Average Price per Dose |
Estimated Annual Cost |
| 2019 |
$6,000 |
$36,000- $40,000 |
| 2020 |
$6,150 |
$37,000- $42,000 |
| 2021 |
$6,250 |
$38,500- $43,000 |
| 2022 |
$6,200 |
$38,000- $43,000 |
Pricing stability reflects limited patent expirations and high demand; no significant biosimilar competition in the short term.
Future Price Projections
- Price hikes are projected at an annual rate of 2-3%, consistent with inflation and healthcare policy pressures.
- Introduction of biosimilars could eventually lower prices by 15-25%, but this is not imminent in the US due to patent protections ending no earlier than 2028 for the original molecule.
Regulatory and Market Dynamics
Patent and Exclusivity
- The original patent expired in 2026, but second-generation formulations and manufacturing patents extend market exclusivity until 2028–2030.
- A biosimilar pathway could introduce competition, but regulatory hurdles and FDA approval timelines delay market entry.
Reimbursement Environment
- Payers favor high-efficacy biologics; Entyvio’s payer coverage is stable.
- Managed care organizations implement strict step therapy, potentially limiting introduction of biosimilars.
Price Projections Summary
| Year |
Estimated Wholesale Price per Dose |
Annual Treatment Cost |
Market Share Projection |
| 2023 |
$6,300 |
$38,500 |
8% of IBD market |
| 2024 |
$6,500 |
$39,800 |
Slight increase in share due to stable efficacy |
| 2025 |
$6,700 |
$41,100 |
Potential expansion, competition not yet significant |
| 2026 |
$6,900 |
$42,300 |
Patent expiration approaches |
| 2027 |
$7,000 |
$43,000 |
Biosimilar entry possible, prices drop 15-20% |
Recommendations for Stakeholders
- Investors: Monitor patent expiration dates and biosimilar development. Potential for price decline post-2028.
- Manufacturers: Focus on expanding indications and optimizing infusion protocols to maintain premium pricing.
- Payers: Evaluate cost-effectiveness to negotiate for lower prices amid biosimilar entry.
Key Takeaways
- Currently, Entyvio maintains a stable ~$6,200 per dose, with annual costs around $40,000.
- The US IBD biologic market is growing at 6-8% annually, with Entyvio holding an 8% share.
- Price increases are projected at 2-3% annually; biosimilar competition could reduce prices by 15-25% starting around 2028.
- Patent expirations and regulatory pathways will influence the timing and extent of future price pressure.
- The market remains lucrative for biologics with high reimbursement rates and limited immediate biosimilar competition.
FAQs
1. How likely is a biosimilar to Entyvio in the US?
Potential biosimilar entry could occur around 2028, contingent on patent expiry and regulatory approval processes.
2. Will market share for Entyvio increase?
Yes, due to its favorable safety profile and gut-specific action, market share may expand if new indications are approved and utilization grows.
3. Are future price reductions expected?
Biosimilar competition is likely to reduce prices by 15-25%, starting approximately three years post-approval of the first biosimilar.
4. How does Entyvio compare to competitor biologics?
It offers gut selectivity, fewer systemic side effects, and is administered via infusion, giving it a niche advantage over some systemic biologics like Humira.
5. What factors could influence Entyvio’s pricing outlook?
Regulatory changes, patent litigation, biosimilar approvals, and healthcare reimbursement policies will impact future prices.
References
- IQVIA. (2022). Pharmaceutical Market Outlook.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.
- EvaluatePharma. (2022). Global Biologic Market Size and Trends.
- MedPanel. (2022). IBD Market Dynamics.
- Centers for Disease Control and Prevention. (2022). Prevalence of IBD in the US.
[1] (IQVIA, 2022), [2] (FDA, 2022), [3] (EvaluatePharma, 2022), [4] (MedPanel, 2022), [5] (CDC, 2022)
