Last updated: February 16, 2026
Product Overview
NDC 00781-6014 corresponds to a specific drug product, identified as a biologic or small molecule depending on its formulation. Precise classification influences market size, competitive landscape, and pricing strategies. Based on available data, this NDC code is associated with Entyvio (vedolizumab), a monoclonal antibody indicated for inflammatory bowel diseases (IBD), notably ulcerative colitis and Crohn’s disease.
Market Size and Therapeutic Landscape
- Target Patient Population: Approximately 1.4 million US patients diagnosed with IBD, with roughly 40% eligible for biologic therapies [1].
- Market Penetration: As of 2022, Entyvio holds a market share of about 13% among biologic agents for IBD in the US, competing with infliximab, adalimumab, and ustekinumab [2].
- Growth Trends: The IBD biologics market is projected to grow at a compound annual growth rate (CAGR) of 8.4% through 2027 [3], driven by increasing diagnosis rates and expanding indications.
Pricing Landscape
- Current List Price: The wholesale acquisition cost (WAC) for Entyvio is approximately $6,273 per 300 mg vial [4].
- Reimbursement: Medicare and private insurers often reimburse at or below list prices, factoring in discounts, rebates, and negotiations.
- Average Net Price: Estimated at $4,000–$5,000 per dose after rebates and discounts, depending on payer negotiations [5].
Market Entry and Competition
- Patent Expiry and Biosimilars: Entyvio’s patent(s) extend until 2028–2030. Limited biosimilar competition exists as of 2023; some biosimilar applicants have sought approval but none are ruling in the US.
- Potential Biosimilar Impact: Introduction of biosimilars could lead to a 15–25% price reduction within 2–3 years post-launch, mirroring trends seen with infliximab biosimilars [6].
| Price Projections (Next 5 Years) |
Year |
Estimated Average Price Per Dose |
Assumptions |
| 2023 |
$4,800 |
Current negotiated net price; no biosimilar impact yet. |
| 2024 |
$4,600 |
Slight decline due to increased payer negotiating power. |
| 2025 |
$4,400 |
Continued market pressure; inflation-adjusted. |
| 2026 |
$4,000 |
Biosimilar approvals increase; volume expansion. |
| 2027 |
$3,800 |
Biosimilar competition in the US; price reductions solidify. |
Note: These estimates are subject to change based on regulatory decisions, market dynamics, and patent litigation.
Key Market Risks and Opportunities
- Risks: Patent litigation delaying biosimilar entry; payer resistance driving down profit margins; pricing regulations becoming more stringent.
- Opportunities: Expanded indications, like pediatric Crohn’s disease, could grow revenue; partnerships with biosimilar developers may create new pricing strategies.
Regulatory and Policy Environment
Recent policy initiatives aim to cap out-of-pocket costs and promote biosimilars. The Inflation Reduction Act of 2022 enforces inflation-based rebates for drug price increases exceeding inflation rates, influencing net pricing strategies.
Summary
NDC 00781-6014 (Entyvio) operates in a growing IBD biologics market, with stable list prices around $6,273 per 300 mg vial. Realized net prices hover between $4,000 and $5,000. Market forecasts indicate a gradual decline of 21–25% over five years, accelerated by biosimilar entrants and payer negotiations.
Key Takeaways
- Entyvio’s US market shares around 13% of IBD biologic therapies.
- Current net prices range $4,000–$5,000, with list prices about $6,300 per vial.
- Market growth driven by increasing IBD diagnoses and expanding indications.
- Biosimilar competition expected from 2028–2030 could trim prices by 15–25% within three years post-launch.
- Regulatory pressures may influence future pricing strategies and reimbursement levels.
FAQs
1. How does Entyvio’s price compare to competitors?
Entyvio’s list price is comparable to other biologics, such as Stelara (~$6,846 per dose) and Humira (~$6,000 per injection), but net prices vary depending on rebates and negotiations.
2. What factors could accelerate biosimilar entry?
Patent expiration, successful biosimilar approvals, and payer acceptance influence biosimilar market penetration.
3. How do discounts and rebates affect net pricing?
Rebates typically reduce list prices by 20–30%, bringing net prices closer to $4,000–$5,000 per dose for payers.
4. What role do regulatory changes play in pricing?
Policies like inflation rebates and exclusive licensing can limit price increases and influence biosimilar adoption.
5. What markets beyond the US could impact Price projections?
European and Asian markets are expected to see price pressures, especially where biosimilars gain approval and market share.
References
- CDC. Inflammatory Bowel Disease Statistics. 2020.
- IQVIA. United States. Biologics Market Data. 2022.
- Research and Markets. IBD Market Forecast. 2022.
- Red Book. Drug Pricing Data. 2023.
- SSR Health. Estimated Net Price Reports. 2022.
- FDA. Biosimilar Approvals and Market Entry. 2023.
Prepared by:
[Your Name]
Drug Patent & Market Analyst
