Last updated: March 9, 2026
What is the drug identified by NDC 00338-1125?
NDC 00338-1125 corresponds to Eliquis (apixaban) 5 mg tablets. Eliquis is an anticoagulant indicated for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and reduction of risk of recurrent DVT and PE.
Market Overview
Current Market Size and Growth
Eliquis's global sales reached approximately $8.29 billion in 2022, according to IQVIA data.[1] The U.S. accounted for nearly 75% of sales. The anticoagulant segment experienced compound annual growth rate (CAGR) of 8% between 2018 and 2022, driven by expanding indications and patent protections.
Competitive Landscape
Eliquis competes with warfarin, Xarelto (rivaroxaban), Pradaxa (dabigatran), and Savaysa (edoxaban). The market has shifted away from warfarin due to lower bleeding risk associated with direct oral anticoagulants (DOACs).
Key Market Drivers
- Increase in atrial fibrillation prevalence (estimated 6.1 million U.S. adults)[2].
- Growing awareness of anticoagulant benefits.
- Expanding indications for DOACs.
- Patent exclusivity in key markets until 2030, with some competition from biosimilars and generics expected post-expiration.
Price Analysis
Current Pricing Landscape
As of 2023, the average wholesale acquisition cost (WAC) for Eliquis 5 mg is approximately $500 per monthly supply (30 tablets). This price reflects standard insurance net prices with co-pays and discounts.
| Parameter |
Data Point |
| WAC price (per month) |
~$500 |
| Typical co-pay (insured) |
$10–$50 |
| Uninsured price |
$500–$550 |
Price Trends
The list price for Eliquis has been stable over the last three years, with marginal increases (~2-3% annually). Pricing inflation stems from manufacturing costs and market demand rather than regulatory or patent-driven price hikes.
Price Projections
Short-term (1–2 years): No significant price decline anticipated given current patent protection and brand dominance. Expect a slight increase (~1%) aligned with inflation.
Medium-term (3–5 years): Upon patent expiration in key markets (expected around 2028–2030), biosimilar competition may reduce prices by 20–40%. Generic versions could launch at approximately $300–$350 per month.
Long-term (post-2030): Price reductions will depend on market penetration of biosimilars and regulatory policies. Projected prices could settle around $250–$300 per month, assuming high competitive uptake.
Regulatory and Patent Landscape
- Eliquis's core patents expire in 2028 in the U.S. and European markets.[3]
- Patent litigations and legal challenges could influence entry timing of generics.
- Biosimilar approvals are limited; however, small-molecule generics are expected to enter the market first.
Revenue Forecasts
Assuming a market share dominance (70%) and stable sales of $8.29 billion in 2022, Eliquis's revenue could decline by 20% post-generic entry due to price competition. A conservative forecast estimates revenue might fall below $6 billion by 2030.
Strategic Implications
- Patent expiration threatens sustained revenue; investment in new indications or formulations is crucial.
- Price reductions post-generic entry could impact profitability but present opportunities for market share expansion through affordability.
- Competitive strategies include exclusive distribution agreements and patient assistance programs.
Key Takeaways
- Eliquis (NDC 00338-1125) holds a leading position in anticoagulant therapy with stable pricing until patent expiration.
- The market is poised for price competition around 2028 when biosimilar and generic versions launch.
- Near-term prices are stable at approximately $500/month, with potential decreases of 20–40% after patent expiry.
- Revenue projections show a decline post-generic entry, emphasizing the need for pipeline development.
- Market growth will depend on demographic trends and regulatory decisions on biosimilars.
FAQs
Q1: When are Eliquis’s patents expected to expire?
A1: Core patents in the U.S. are set to expire around 2028.
Q2: What factors influence the pricing of Eliquis?
A2: Patent status, competition, manufacturing costs, and insurance negotiations.
Q3: How will biosimilar entry affect Eliquis’s market?
A3: Biosimilars could reduce prices by 20–40% and decrease Eliquis’s market share.
Q4: Are there any licensing or legal challenges that could delay generic entry?
A4: Yes, patent litigations and legal challenges can delay generic approval, potentially extending Eliquis's exclusivity.
Q5: What are alternative therapies if Eliquis’s price drops or it loses market share?
A5: Alternatives include warfarin, Xarelto, Pradaxa, and Edoxaban, depending on patient-specific factors and indication.
References
[1] IQVIA. (2022). IQVIA Market Data.
[2] Benjamin, E. J., et al. (2019). Heart Disease and Stroke Statistics—2019 Update. Circulation.
[3] U.S. Patent and Trademark Office. (2022). Patent expiration dates.
