Last updated: February 21, 2026
What is NDC 51672-4069?
NDC 51672-4069 corresponds to Vedolizumab (sold under the brand name Entyvio), used primarily for inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. It is a biologic monoclonal antibody targeting integrin α4β7, which inhibits lymphocyte migration to intestinal tissue.
Market Overview
Current Market Size
The global inflammatory bowel disease (IBD) therapeutics market was valued at approximately USD 8.8 billion in 2022, with biologic therapies accounting for over 70% of prescriptions. Vedolizumab holds a significant share within this segment, with estimated sales of around USD 2.4 billion in 2022, primarily driven by the U.S., Europe, and emerging markets.
Key Competitors
- Adalimumab (Humira): Leader in IBD biologics, $20+ billion annual sales.
- Infliximab (Remicade): Estimated $9 billion/year.
- Ustekinumab (Stelara): Approx. $4 billion/year.
- Vedolizumab (Entyvio): Estimated at $2.4 billion/year.
Market Dynamics
- Growth Drivers: Rising IBD prevalence (approximately 5 million globally), increased biologic adoption, expanding indications, and patient access improvements.
- Market Challenges: High treatment costs, competition from biosimilars, and recent patent expirations for some biologics.
Price Projections
Current Pricing Landscape
In 2023, the wholesale acquisition cost (WAC) for Entyvio was approximately USD 5,500 per 300 mg vial, with treatment courses averaging USD 30,000 to USD 40,000 annually per patient, depending on dosing frequency.
Future Price Trends (2023-2028)
| Year |
Estimated WAC per vial |
Estimated Annual Cost per Patient |
Price Influencers |
| 2023 |
USD 5,500 |
USD 30,000 - USD 40,000 |
Current market, manufacturing costs, payer negotiations |
| 2024 |
USD 5,600 |
USD 32,000 - USD 42,000 |
Slight price increases, inflation impacts, potential biosimilar entry |
| 2025 |
USD 5,700 |
USD 33,000 - USD 44,000 |
Increasing adoption, new indications, negotiations ease |
| 2026 |
USD 5,800 |
USD 34,000 - USD 45,000 |
Competitive pressures, patent exclusivity decline |
| 2027 |
USD 6,000 |
USD 35,000 - USD 46,000 |
Potential biosimilar competition impacts, reimbursement policies |
| 2028 |
USD 6,200 |
USD 36,500 - USD 48,000 |
Biosimilar market development, manufacturing efficiencies |
Price Drivers
- Patent Lifecycle: Loss of exclusivity for Entyvio's key patents slated for 2025-2026 could lead to biosimilar entry, pressuring prices.
- Biosimilar Competition: Entry of biosimilars could reduce prices by 20%-40%, depending on market penetration.
- Regulatory and Payer Policies: Increased emphasis on value-based pricing may moderate price increases and incentivize discounts or rebates.
- Manufacturing Costs: Advances in cell culture, process efficiencies, and supply chain improvements may slow price increases.
Market Penetration and Adoption
- Prescription Trends: Increased use in earlier lines of therapy, especially if costs decline.
- Geographic Expansion: Emerging markets and better payer coverage could drive volume growth.
- Combination Therapies: Synergies with other biologics or small molecules might influence overall sales volume.
Risks and Opportunities
Risks
- Biosimilar Competition: Entry expected post-2025, potentially reducing revenue.
- Regulatory Changes: Policies favoring cost containment could impact pricing.
- Market Saturation: Increased use of oral or small-molecule alternatives.
Opportunities
- Expanded Indications: Use in other immune-mediated inflammatory diseases.
- New Formulations: Extended-release or subcutaneous formulations could influence adherence and pricing.
- Strategic Collaborations: Licensing or partnerships could facilitate market expansion.
Summary
NDC 51672-4069 (Vedolizumab) remains a high-value biologic in IBD, with sales expected to grow moderately over the next five years. Pricing adapts gradually, with potential downward pressure beginning in 2025 as biosimilars enter the market. The overall revenue outlook depends on market penetration, patent timelines, and policy environments.
Key Takeaways
- Vedolizumab (Entyvio) generated approximately USD 2.4 billion in sales in 2022.
- Current list price per vial is around USD 5,500, with annual treatment costs near USD 30,000-40,000.
- Prices are expected to increase marginally until patent expirations around 2025-2026.
- Biosimilar entry anticipated post-2025 could reduce prices by 20-40%.
- Market growth driven by rising IBD prevalence, expanded indications, and geographic expansion.
FAQs
Q1: When will biosimilars for Vedolizumab enter the market?
A1: Biosimilar development is underway, with approval and launch expected around 2025-2026, following patent expiry.
Q2: How might price reductions impact revenue projections?
A2: A 20-40% price reduction could decrease annual sales by approximately USD 400 million to USD 1 billion, depending on market share.
Q3: What factors could accelerate Vedolizumab's market growth?
A3: New indications, increased adoption in earlier treatment lines, and geographic expansion.
Q4: Are there upcoming regulatory changes affecting pricing?
A4: Potential legislation favoring cost-effectiveness and value-based payment models could influence list prices and reimbursement.
Q5: How does Vedolizumab compare to competing biologics in terms of market share?
A5: It holds a niche position with roughly 10-15% of biologic IBD prescriptions, trailing faster-growing agents like adalimumab and infliximab.
