Last updated: February 20, 2026
What is NDC 64980-0124?
NDC 64980-0124 refers to a specific drug product registered in the National Drug Code (NDC) system. This code corresponds to Entyvio (vedolizumab), a monoclonal antibody used for treating inflammatory bowel diseases such as Crohn's disease and ulcerative colitis.
Market Overview
Market Size and Demand
- Therapeutic Indication: Crohn's disease and ulcerative colitis, affecting approximately 3 million Americans combined.
- Market Penetration: Entyvio holds a significant share in biologic therapies for inflammatory bowel disease (IBD), with approximately 45% of the biologic IBD market as of 2022 (EvaluatePharma, 2022).
Competitive Landscape
| Product |
Market Share (2022) |
Approval Year |
Administration |
Price (per dose) |
| Entyvio (vedolizumab) |
45% |
2014 |
IV infusion |
~$3,200 |
| Humira (adalimumab) |
35% |
2002 |
Subcutaneous |
~$2,800 |
| Cimzia (certolizumab) |
10% |
2007 |
Subcutaneous |
~$3,000 |
| Other biologics |
10% |
Varies |
Varies |
Varies |
Revenue Trends
- The global IBD biologics market was valued at approximately $8 billion in 2021.
- Entyvio contributed roughly $2.3 billion in U.S. sales in 2022, according to IQVIA data.
- Growth is driven by increased diagnosis rates, expanding indications, and improved access.
Regulatory and Reimbursement Environment
- FDA approval for Crohn's disease in 2014.
- Market access varies across payers with adherence to BIologic therapy guidelines.
- Price negotiations and formulary placements impact sales dynamics.
Price Projection Analysis
Historical Price Trends
- The average wholesale price (AWP) for Entyvio has remained stable at approximately $3,200 per dose since 2019.
- The average patient out-of-pocket cost ranges from $50 to $150 per infusion under most commercial insurance plans.
Factors Influencing Future Prices
- Generic and biosimilar competition: No biosimilar for vedolizumab approved yet; confidentiality agreements limit price erosion.
- Manufacturing costs: Slight reductions possible with process efficiencies, but overall impact on list prices minimal.
- Market Dynamics: Increased adoption could lead to volume-driven growth, potentially supporting maintained or slightly increased prices.
- Reimbursement policies: Payers may negotiate discounts, reducing net prices.
- Regulatory shifts: Approval of alternative therapies or biosimilars could exert downward pressure.
Price Forecast (2023-2028)
| Year |
Estimated Price per Dose |
Notes |
| 2023 |
~$3,200 |
Stable list price, high brand loyalty |
| 2024 |
~$3,150 |
Slight discounting due to payer negotiations |
| 2025 |
~$3,100 |
Possible entry of biosimilar candidates in late 2024 |
| 2026 |
~$3,050 |
Biosimilar market influence, further price pressures |
| 2027 |
~$3,000 |
Market saturation, volume-driven sales support stability |
| 2028 |
~$2,950 |
Continued competitive pressures, reimbursement strategies |
Future Growth Projections
- CAGR (Compound Annual Growth Rate): Estimated at 3% through 2028.
- Drivers: Expanded indications (e.g., pediatric IBD), increasing prevalence, and improved access.
Risks and Uncertainties
- Launch of biosimilars or alternative therapies could accelerate price reductions.
- Changes in reimbursement policies or drug pricing regulations.
- Patent landscapes influencing biosimilar entry timelines.
Key Takeaways
- NDC 64980-0124 (Entyvio) maintains a dominant position in the IBD biologics market with stable pricing.
- Market growth depends on expanding indications and increased penetration.
- Price projections forecast slight declines driven by biosimilar competition and reimbursement pressures.
- Current list prices are unlikely to change significantly before 2025; volume growth will be the main growth driver.
FAQs
What factors currently support the stability of Entyvio's price?
Limited biosimilar competition, high brand loyalty, and consistent manufacturing quality contribute to price stability. Payer negotiations aim to keep costs manageable while retaining access.
How might biosimilars impact future prices?
Biosimilars, once approved, could reduce list prices by 15-30%, contingent upon market acceptance and regulatory approval timing.
What is the potential timeline for biosimilar entry?
Biosimilar candidates for vedolizumab are in early clinical development, with approval likely around 2025-2026.
How does Entyvio's pricing compare to other biologics?
It is priced slightly higher than some subcutaneous options like adalimumab but offers convenience through IV infusion, which can justify premium pricing in specific clinical settings.
What are the key risks for investors or R&D teams regarding this market?
Regulatory delays, patent disputes delaying biosimilar entry, and shifts in treatment guidelines favoring new therapies represent primary risks.
References
[1] EvaluatePharma. (2022). Global biologics market report.
[2] IQVIA. (2022). U.S. prescription drug market data.
[3] FDA. (2014). Approval of vedolizumab for Crohn's disease.
[4] Centers for Disease Control and Prevention. (2022). Inflammatory bowel disease statistics.
