Last updated: February 25, 2026
What is NDC 00228-2597?
NDC 00228-2597 refers to a prescription drug, identified within the National Drug Code system. The specific medication is Eliquis (apixaban), an oral anticoagulant used for stroke prevention in non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE).
Current Market Landscape
Market Size and Demand
Eliquis is a leading agent in the direct oral anticoagulant (DOAC) class. In 2022, the global anticoagulant market was valued at approximately USD 9.3 billion, with Eliquis capturing around 43% of the market share in the United States, according to IQVIA data.
Key Competitors
- Pradaxa (dabigatran)
- Xarelto (rivaroxaban)
- Savaysa (edoxaban)
Eliquis's market share stems from FDA approval expansions and increased use in atrial fibrillation, venous thromboembolism, and post-surgical prophylaxis.
Regulatory Status
Eliquis received FDA approval for multiple indications from 2012 through 2020. Its patent expiration date is expected around 2026, with some jurisdictions facing patent challenges earlier. Patent cliffs influence pricing and market entry.
Patient and Prescriber Trends
- The aging population sustains demand.
- Accelerated adoption of DOACs over warfarin due to ease of use.
- Growing awareness of clot prevention therapies.
Price Trends and Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 500 for a 60-count, 5 mg tablet pack.
- Average Selling Price (ASP): Estimated around USD 430 per pack.
- Out-of-pocket costs: Vary with insurance, averaging USD 20-50 per prescription.
Historical Price Trends
Since FDA approval, Eliquis's price has remained relatively stable; however, a slight downward trend is observed correlating with increased competition and patent challenges.
Price Drivers
- Patent expiration approaching in 2026.
- Entry of biosimilar or generic options.
- Insurance formulary negotiations.
- Policy changes impacting high-cost drug coverage.
Future Price Projections
| Year |
Estimated Price per Pack |
Key Drivers |
| 2023 |
USD 430 |
Current market, stable competition |
| 2024 |
USD 415 |
Anticipated generic entry negotiations |
| 2025 |
USD 385 |
Increased biosimilar competition, patent still active |
| 2026 |
USD 350 |
Patent expiry, generics/biosimilars launch |
Projections assume no major policy disruptions or extraordinary market shifts.
Market Entry and Competition
Biosimilar and generic versions could enter the market within 1-2 years following patent expiry, likely reducing prices by 40-60%. The exact timing of generic approvals depends on patent litigations and regulatory review durations.
Reimbursement and Pricing Policies
Reimbursement rates from Medicare, Medicaid, and private insurers influence retained revenue and pricing strategies. Price reductions are expected as payers push for cost containment following patent expiry.
Summary of Market Dynamics
- Eliquis remains dominant due to its clinical profile and prescriber preference.
- Patent expiration looms, risking rapid price erosion.
- Competitive pressures from biosimilars and generics will likely drive prices downward over the next 2-3 years.
- Price stability will depend on market strategies, patent litigation outcomes, and payer negotiations.
Key Takeaways
- The current market for NDC 00228-2597 (Eliquis) is mature, with robust demand driven by cardiovascular indications.
- Prices are expected to decline gradually as patent expiry approaches, potentially decreasing by 35-50% within five years.
- Competition from biosimilars and generics is imminent, influencing price strategies and market share.
- Reimbursement policies will significantly impact net revenue, with payers increasingly favoring lower-cost alternatives.
- Monitoring patent litigation and regulatory approvals for biosimilars remains critical for market forecasting.
FAQs
-
When is Eliquis's patent set to expire?
Around 2026, with patent challenges potentially altering the timeline.
-
What is the predicted price decline after patent expiry?
Prices could fall by 40-60% within two years of generic entry.
-
Are biosimilars likely to impact Eliquis's market?
Yes, biosimilars or generics could significantly reduce prices and market share starting in 2026.
-
How do insurance policies influence Eliquis pricing?
Insurance coverage and formulary placements determine patient out-of-pocket costs and reimbursement rates, affecting revenue.
-
What is the critical factor in Eliquis's future marketability?
Patent litigation outcomes and regulatory approvals for generic versions.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] U.S. Food and Drug Administration. (2020). Eliquis FDA approval history.
[3] EvaluatePharma. (2022). Top Pharmaceutical Brands by Market Share.
[4] Reuters. (2023). Patent litigation and biosimilar approvals impact on drug pricing.
