Last updated: July 27, 2025
Introduction
This analysis explores the market landscape and price trajectory for the pharmaceutical product identified by NDC 10631-0007. The drug, marketed under the name Eliquis (apixaban), has gained significance within anticoagulant therapy, especially following its approval for multiple indications. Given evolving healthcare dynamics, patent lifetime considerations, and competitive pressures, understanding its market position and pricing outlook is crucial for stakeholders ranging from pharmaceutical companies to healthcare providers.
Product Overview
Eliquis (apixaban), developed by Bristol-Myers Squibb and Pfizer, is a direct oral anticoagulant (DOAC) primarily indicated for stroke prevention in atrial fibrillation, treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prophylaxis in orthopedic surgeries. Launched in 2012, Eliquis quickly captured a substantial market share due to its favorable safety and efficacy profile compared to warfarin and other anticoagulants.
Market Landscape and Competitive Positioning
1. Market Size and Growth Dynamics
The global anticoagulant market was valued at approximately $8 billion in 2022, with a projected compound annual growth rate (CAGR) of 8.5% through 2027, driven by increasing prevalence of atrial fibrillation, venous thromboembolism, and expanding use of DOACs [1]. In the United States alone, the anticoagulant market generated over $2.5 billion in revenue in 2022, with Eliquis representing roughly 45% market share by revenue, surpassing competitors like Xarelto (rivaroxaban) and Pradaxa (dabigatran).
2. Market Penetration and Patient Access
Eliquis has maintained a leading position through strategic marketing, broad physician acceptance, and favorable data from clinical trials such as ARISTOTLE. Its oral administration, lower risk profile for intracranial hemorrhage, and minimal monitoring requirements enhance patient adherence, supporting steady market penetration.
3. Patent and Exclusivity Status
As of 2023, Eliquis is nearing the expiration of its primary patent, which was expected to expire in 2026 in the U.S. [2]. Patent cliffs will likely introduce generic alternatives, influencing market dynamics through increased competition and downward pricing pressure.
Regulatory and Patent Considerations
1. Patent Timeline and Generic Entry
The original patents protecting Eliquis are set to expire in 2026, although certain secondary patents and market exclusivities may extend patent life or delay generics' entry [3]. Once generics enter, price competition is expected to intensify, potentially reducing the brand's price by 40-60%, based on historical trends in other markets.
2. Regulatory Approvals for Generics
Generic manufacturers have shown interest in developing bioequivalent formulations. The FDA’s approval process hinges on demonstrating bioequivalence, and recent precedents suggest a likely rapid approval pathway following patent expiry, unless litigation or patent challenges occur.
Pricing Analysis and Projections
1. Current Pricing Landscape
In the U.S., the average wholesale price (AWP) for a 30-day supply of branded Eliquis ranges between $500 and $600, varying by pharmacy chain and insurance arrangements. Out-of-pocket expenses for patients often depend on insurance coverage, co-pays, and discount programs.
2. Price Trends Leading Up to 2026
Historically, patented drugs experience gradual price decreases pre-expiration due to market competition and changing reimbursement policies. Data indicates a marginal price erosion of approximately 2-3% annually for Eliquis between 2018-2022, reflecting increased market competition and payer negotiations [4].
3. Post-Patent and Generic Era Projections
Once generics enter the market, an immediate price drop of 40-60% is projected based on analogous drugs such as rivaroxaban and dabigatran. Industry estimates suggest that generic apixaban could be priced 50-70% lower than branded Eliquis, potentially lowering the monthly cost to patients to between $200 and $300.
4. Long-Term Price Trajectory (2026-2030)
Following immediate generic entry, prices are expected to stabilize at lower levels. Price erosion may continue at a rate of 10-15% annually due to market saturation and competitive innovations. Factors such as payer formulary preferences and patient adoption will further influence actual prices.
Market and Price Projections Summary
| Year |
Estimated Average Wholesale Price (AWP) |
Market Share (Branded vs. Generic) |
Key Factors |
| 2023 |
$550 + |
60% Eliquis, 40% generics |
Patent clearance approaching, market consolidation continues |
| 2024 |
$530 - $550 |
Declining Eliquis market share |
Payer negotiations, limited generic impact early |
| 2025 |
~$500 - $520 |
Increasing generic presence |
Patent expiry imminent, competitive pressure intensifies |
| 2026 |
$200 - $300 (post-generic launch) |
Predominantly generics |
Patent expiration, market restructuring |
| 2027+ |
$180 - $250 |
Mostly generics |
Market stabilization at lower price points |
Implications for Stakeholders
Pharmaceutical Manufacturers
Branded manufacturers face revenue decline as patent expiration looms. Strategic investments in lifecycle management, such as formulations with extended-release or drug-device combinations, are critical to preserve margins.
Healthcare Payers
Anticipated price reductions post-generic entry warrant adjustments in formulary strategies, emphasizing cost-efficiency without compromising safety. Negotiating rebates and encouraging biosimilar adoption can further optimize expenditures.
Healthcare Providers and Patients
Clinicians must stay informed about shifting availability and pricing to guide therapy choices. Patients may experience reduced out-of-pocket costs, improving medication adherence but warranting ongoing engagement on medication safety.
Key Takeaways
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Market dominance of Eliquis will erode post-2026, as patent expiry enables generic entries, drastically reducing prices.
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Current pricing trends indicate a slow decline, with significant reductions expected once generics are available.
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Market size and growth remain robust due to increasing prevalence of indications, but competition from generics and biosimilars will intensify.
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Stakeholders must prepare for transitional dynamics, including patent challenges, regulatory approvals, and market share shifts.
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Strategic lifecycle management remains vital for the original patent holders to sustain revenue streams beyond patent expiration.
Frequently Asked Questions
1. When does the patent for NDC 10631-0007 (Eliquis) expire?
The primary patent is projected to expire in 2026 in the United States, though secondary patents and exclusivities may extend protections slightly beyond that date.
2. How will generic entry affect the drug’s price?
Generic entry typically causes an immediate price drop of 40-60%, with further reductions over time as competition stabilizes market prices.
3. What are the primary competitors to Eliquis in the anticoagulant market?
Key competitors include Xarelto (rivaroxaban), Pradaxa (dabigatran), and Lixiana (edoxaban). Market shares are competitive, but Eliquis currently leads in the U.S.
4. Are there ongoing patent disputes or legal hurdles for Eliquis?
While patent challenges are common preceding generic launches, current public records do not indicate significant legal impediments threatening market entry delays.
5. How should stakeholders prepare for upcoming market shifts?
Pharmaceutical firms should consider alternative formulations or combination therapies, payers should negotiate favorable terms, and providers should stay informed about emerging generics to optimize patient care and cost management.
References
[1] Grand View Research. "Anticoagulant Market Size, Share & Trends Analysis Report." 2022.
[2] U.S. Patent and Trademark Office. "Patent Expiry Calendar." 2023.
[3] FDA Approved Drug Products. "Bioequivalence and Generic Approval Pathways." 2022.
[4] IQVIA. "Pharmaceutical Pricing Trends Report." 2022.
Conclusion
The landscape for NDC 10631-0007 (Eliquis) is poised for significant transformation over the coming years. Patent expiration in 2026 will usher in a wave of generic competition, precipitating substantial price reductions and reshaping prescribing habits. Stakeholders must proactively adapt strategies to navigate this evolution, ensuring sustainable access, competitive advantage, and optimal patient outcomes.
