Last updated: July 28, 2025
Introduction
The drug identified by NDC 00054-3185 is Eliquis (apixaban), marketed by Bristol-Myers Squibb and Pfizer. Apixaban is an oral anticoagulant used primarily to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation, treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduce the risk of recurrence. As a leading anticoagulant, Eliquis has carved out a significant share of the oral anticoagulant market, competing directly with warfarin and newer agents like rivaroxaban and dabigatran.
The following report provides a comprehensive market analysis, including current market dynamics, competitive landscape, regulatory environment, and price projections for Eliquis over the next five years.
Market Overview
Global and U.S. Market Size
The global anticoagulant market was valued at approximately USD 7.2 billion in 2021, with expected compound annual growth rate (CAGR) of 7.3% through 2028 [1]. The U.S., representing roughly 40% of this market, is projected to reach USD 3 billion by 2025, driven by increasing prevalence of atrial fibrillation, DVT, and PE, along with rising awareness and diagnosis rates.
Disease Burden and Demographics
- Atrial Fibrillation (AF): Affects over 37 million adults worldwide, with prevalence rising due to aging populations [2].
- Venous Thromboembolism (VTE): Incidence estimated at 1-2 per 1,000 annually, with higher rates in older adults [3].
The shift towards outpatient management and preference for oral anticoagulants over injectable therapies bolster Eliquis's growth potential.
Competitive Landscape
Eliquis faces competition from:
- Xarelto (rivaroxaban): Market leader with approximately 30-35% share.
- Dabigatran (Pradaxa): Still significant but declining.
- Warfarin: Historically dominant but phased out due to safety and monitoring issues.
Eliquis has distinguished itself through favorable bleeding profiles, once-daily (rivaroxaban) and twice-daily dosing, and extensive clinical trial data supporting efficacy.
Regulatory and Reimbursement Environment
- FDA Approval: Approved for various indications, including stroke prevention, VTE treatment, and postoperative DVT prophylaxis.
- Pricing & Reimbursement: Variability exists, with retail prices in the US averaging USD 500–600 monthly per prescription. Payers increasingly favor NOACs over warfarin, facilitating access and reimbursement.
Current Pricing Landscape
Pharmacoeconomic Considerations
- Average Wholesale Price (AWP): For Eliquis, the average retail price per month ranges from USD 520–600, depending on dosage and pharmacy.
- Insurance & Discounts: Rebates, pharmaceutical assistance programs, and institutional negotiations influence net prices.
Price Trends
Over the past five years, list prices for Eliquis have remained relatively stable, with minor fluctuations due to market competition, generic approvals, and pricing strategies.
Market Dynamics Influencing Future Price Projections
-
Patent Status and Generics:
- Pfizer and Bristol-Myers Squibb hold patents until 2030, with potential for biosimilar or complex generic entry thereafter.
- Patent challenges could lead to future price reductions, but current brand dominance remains.
-
Clinical Data and Label Expansion:
- Ongoing trials exploring additional indications may extend market exclusivity.
- Positive safety and efficacy data reinforce current positioning, supporting sustained pricing.
-
Competitive Innovation:
- Development of reversal agents (e.g., Andexanet alfa) enhances safety but impacts costs.
- The emergence of alternative therapies or personalized medicine could reshape the landscape.
-
Market Penetration in Emerging Markets:
- Growing adoption in Asia, Latin America, and Eastern Europe, where pricing sensitivity is higher, may exert downward pressure on prices.
-
Reimbursement Policies:
- Payer strategies favoring cost-effective therapies could influence negotiated prices and discounts.
Price Projection for the Next Five Years
Based on current trends, competitive forces, and regulatory considerations, the following projections are made:
| Year |
Estimated Monthly Price (USD) |
Rationale |
| 2023 |
$520 – $600 |
Stabilized pricing with ongoing demand |
| 2024 |
$510 – $590 |
Slight downward pressure from generic biosimilar negotiations, continued competitiveness |
| 2025 |
$500 – $580 |
Marginal price reductions, enhanced competition in emerging markets |
| 2026 |
$490 – $560 |
Potential entry of biosimilars or complex generics, market expansion stabilizes |
| 2027 |
$480 – $550 |
Increased biosimilar availability, shift toward lower-cost alternatives |
Note: These estimates reflect list pricing; actual net prices depend heavily on rebates, discounts, and negotiated rates.
Impact of External Factors
- Patent Expiry: The expiration of key patents post-2030 could precipitate significant price reductions driven by biosimilar and generic competition.
- Regulatory Developments: Approval of new indications or safety updates could influence market penetration and pricing strategies.
- Healthcare Policy Changes: Shifts toward value-based pricing could incentivize price negotiations and utilization constraints, leading to reduced prices overall.
Implications for Stakeholders
- Manufacturers: Should prioritize clinical trial outcomes and biosimilar development to sustain pricing power.
- Payers: May leverage formulary management and negotiated discounts to control costs.
- Investors: Can anticipate stable revenue streams pre-patent expiry with potential declines post-expiration unless new value propositions emerge.
Key Takeaways
- Market Position: Eliquis maintains a dominant position in the oral anticoagulant market, supported by extensive clinical data and favorable safety profiles.
- Pricing Stability: Current retail prices remain stable but face downward pressure from potential biosimilar entry and increased competition.
- Future Price Trajectory: Expect gradual reductions, especially beyond 2025, influenced predominantly by biosimilar developments and market expansion in emerging regions.
- Strategic Considerations: Manufacturers should focus on innovation, label expansion, and strategic pricing to preserve market share.
- Regulatory and Competition Risks: Patent expirations beyond 2030 could reshape the competitive landscape, influencing long-term pricing dynamics.
FAQs
1. When are biosimilars or generics for Eliquis expected to enter the market?
Biosimilar development for complex molecules like apixaban faces regulatory and manufacturing hurdles. No biosimilar has yet received FDA approval, but patent protections extend until approximately 2030, after which biosimilar competition is anticipated.
2. How does Eliquis pricing compare to competing anticoagulants?
Eliquis generally commands a price in the USD 520–600 monthly range, slightly higher than rivaroxaban (Xarelto), which costs around USD 470–550. Warfarin remains significantly cheaper but requires regular monitoring. The choice hinges on clinical and safety considerations rather than price alone.
3. How do payer policies influence Eliquis prices?
Payer negotiations, formulary inclusion, and rebates significantly impact net prices. Favorable coverage and formulary placement increase utilization, indirectly supporting stable pricing.
4. What factors could lead to a substantial price reduction for Eliquis?
Entry of biosimilar or generic competitors, patent expirations, or shifts toward value-based pricing models could induce significant declines in list prices.
5. Will emerging markets sustain or reduce Eliquis prices?
Market expansion in emerging economies often involves price negotiations and lower reimbursement rates, which could pressure Eliquis prices downward in those regions.
References
[1] Grand View Research. Anticoagulants Market Size, Share & Trends Analysis Report, 2021.
[2] Camm AJ, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2020.
[3] White RH, et al. Trends in Venous Thromboembolism Incidence, 2000–2014. JAMA. 2017.
This analysis aims to inform stakeholders on the current market positioning and future price trajectories for NDC 00054-3185 (Eliquis). Stakeholders should consider regional variances, clinical developments, and policy changes when making strategic decisions.
