Last updated: July 31, 2025
Introduction
The drug identified by NDC 00527-1407 is a pharmaceutical product cataloged in the national drug code system, which provides a structured designation for drugs marketed in the United States. Accurate market analysis and price projections for this product are essential for pharmaceutical stakeholders, including manufacturers, healthcare providers, insurers, and investors, to make informed decisions amid evolving industry dynamics.
Drug Profile and Therapeutic Class
The NDC 00527-1407 refers to Eliquis (apixaban) 2.5 mg tablets, an oral anticoagulant marketed by Bristol-Myers Squibb and Pfizer. Apixaban is classified as a direct Factor Xa inhibitor and is primarily prescribed for stroke prevention in atrial fibrillation, treatment, and secondary prevention of venous thromboembolism, and prophylaxis for patients undergoing hip or knee replacement surgeries.
This drug's profile aligns with the broader class of novel oral anticoagulants (NOACs), which have established a significant market share over traditional vitamin K antagonists like warfarin.
Market Landscape and Drivers
1. Growing Incidence of Target Conditions
The global burden of atrial fibrillation (AFib) and venous thromboembolism (VTE) continues to rise, driven by aging populations and lifestyle factors such as obesity and hypertension. The CDC estimates over 6 million Americans afflicted with AFib, with a significant portion on oral anticoagulants. This demographic shift sustains steady demand for apixaban and similar medications.
2. Market Share and Competitor Dynamics
Eliquis holds approximately 43% of the US oral anticoagulant market (as of 2022), trailing only behind Pradaxa (dabigatran) and Xarelto (rivaroxaban). The drug's favorable safety profile, reduced bleeding risks, and once-daily dosing regimen contribute to its strong market position. Competition remains fierce, but Eliquis maintains a dominant standing owing to clinical trial data (ARISTOTLE) and extensive clinical acceptance.
3. Healthcare Policy and Reimbursement Trends
Recent shifts towards value-based care and the emphasis on reducing healthcare costs bolster the adoption of newer anticoagulants like Eliquis. Managed care organizations (MCOs) tend to favor drugs with proven safety, efficacy, and reduced monitoring needs. Reimbursement strategies and formulary placements significantly influence product demand.
4. Patent Status and Generic Entry
Eliquis's primary patent expiration occurred in 2031; however, patent litigations and market exclusivities may influence pricing strategies beforehand. The anticipation of generic versions post-patent expiry will likely lead to price erosion, affecting near-term and long-term revenue projections.
Pricing Trends and Projections
Historical Pricing Context
In the past five years, the average wholesale price (AWP) for Eliquis 2.5 mg tablets has ranged between $4.50 and $6.50 per tablet. The retail prices have remained relatively stable due to its status as a preferred anticoagulant, coupled with patent protections and limited generic competition until the future.
Current Pricing Analysis
As of Q1 2023, the average patient out-of-pocket cost for Eliquis 2.5 mg, after insurance subsidies, is approximately $50 to $70 per prescription, reflecting guidelines, insurance coverage, and negotiated rebates. These prices are influenced heavily by formulary placements and regional differences.
Price Projections (Next 5 Years)
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Short-term (1-2 years):
The current pricing trajectory is expected to remain stable due to continued brand dominance, clinical preference, and limited immediate generic competition. Price increases are projected at 2-3% annually, aligning with inflation and healthcare cost trends.
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Medium-term (3-5 years):
As patent exclusivity nears expiration and biosimilar options become imminent, prices are forecasted to decline significantly—potentially by 25-40% upon generic entry. Pre-expiry, Pfizer and Bristol-Myers Squibb might employ strategies like value-based pricing and patient assistance programs to maintain profitability.
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Post-generic entry (post-2031):
Generic versions could trigger a price reduction of up to 70-80%, aligning with market behavior for similar drugs. Competition may also lead to increased market penetration, lower premiums, and broader accessibility.
Regulatory and Market Factors Impacting Price
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FDA Approvals: Any new indications or formulations for Eliquis could influence pricing by expanding or consolidating market segments.
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Reimbursement Policies: Changes in insurance coverage, especially regarding high-cost medications, will directly impact patient access and demand.
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Global Market Trends: International pricing and utilization patterns, especially in Canada and Europe, influence domestic pricing strategies, given global pharmaceutical market interconnectedness.
Stakeholder Implications
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Manufacturers: Need to balance between maximizing revenue during patent protection and preparing for inevitable patent cliffs via pipeline diversification and biosimilar development.
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Healthcare Providers: Should stay apprised of evolving pricing and formulary inclusions to optimize patient care cost-effectiveness.
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Insurers: Will benefit from anticipated price declines but must manage the transition to generics without compromising quality of care.
Conclusion
The market for NDC 00527-1407 (Eliquis 2.5 mg) remains robust, driven by demographic trends and clinical preference. Prices are expected to stabilize in the short term, with moderate increases aligned with inflation. The advent of patent expiration and generic competition around 2031 will be pivotal in shaping a substantial price decline, potentially transforming market dynamics.
Key Takeaways
- Market Leadership: Eliquis maintains a strong market position due to its efficacy, safety profile, and dosing convenience.
- Pricing Stability: Short-term prices will likely stay stable with minor annual increases; aggressive reductions are expected upon generic entry.
- Patent Expiry Impact: Anticipate a significant decline in drug prices post-2031, with potential for 70-80% reduction.
- Strategic Positioning: Manufacturers should invest in pipeline development and biosimilar strategies to mitigate revenue loss post-patent.
- Market Resilience: Despite upcoming competition, Eliquis’s clinical advantages will sustain its market for the foreseeable future.
FAQs
Q1: When is Eliquis 2.5 mg expected to face generic competition?
A1: Patent rights for Eliquis are expected to expire around 2031, opening the market to generic versions that are anticipated to substantially reduce prices.
Q2: How do insurance policies influence the retail price of Eliquis 2.5 mg?
A2: Insurance coverage, rebates, and formulary placement significantly affect out-of-pocket costs for patients, often reducing the effective retail price.
Q3: What factors might accelerate the entry of biosimilars or generics?
A3: Patent challenges, regulatory approvals, and legal disputes can expedite the introduction of biosimilars or generics, impacting prices earlier than expected.
Q4: How does Eliquis compare cost-wise to other NOACs like rivaroxaban or dabigatran?
A4: While prices vary regionally, Eliquis generally commands higher premiums than some competitors, owing to its clinical profile and extensive data supporting its use.
Q5: What strategic measures can stakeholders adopt in anticipation of patent expiry?
A5: Companies should diversify portfolios, invest in pipeline R&D, and develop biosimilar products to maintain profitability amidst impending generics.
Sources:
[1] IQVIA. (2022). Top-Selling Prescription Drugs.
[2] CDC. (2022). Atrial Fibrillation and Stroke Statistics.
[3] U.S. Food and Drug Administration. (2023). Eliquis (apixaban) Approval and Patent Data.
[4] MarketWatch. (2023). Pharmaceutical Industry Price Trends.
[5] EvaluatePharma. (2022). Forecasting Patent Expirations and Market Impact.