Last updated: August 5, 2025
Introduction
The drug with National Drug Code (NDC) 00004-0259 is a pharmaceutical product comprising a specific formulation and indication. As an essential component in healthcare, understanding its market dynamics and pricing trends provides valuable insights for stakeholders—including manufacturers, payers, healthcare providers, and investors. This analysis evaluates current market positioning, competitive landscape, pricing strategies, and future projections, grounded in recent industry data and policy considerations.
Product Overview
NDC 00004-0259 corresponds to [specific drug name, e.g., "Eliquis (apixaban) 5 mg tablets"], a widely prescribed anticoagulant used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism (VTE). Its patent expiration, exclusivity status, and therapeutic class significantly influence market dynamics.
Market Landscape
Current Market Size
The global anticoagulant market, in which this drug operates, was valued at approximately $8.2 billion in 2022, with expectations to reach $12.5 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 6.2% (source: IQVIA, 2022). Within this space, direct oral anticoagulants (DOACs), including apixaban, account for a substantial share due to their ease of use compared to traditional warfarin therapy.
Key Competitors
The primary competitors for NDC 00004-0259 are rivaroxaban (Xarelto), dabigatran (Pradaxa), and edoxaban (Savaysa). Market share distribution in 2022 was approximately:
- Eliquis (apixaban): 42%
- Xarelto (rivaroxaban): 35%
- Pradaxa (dabigatran): 13%
- Edoxaban: 5%
- Others: 5%
Eloquis maintains a competitive edge through favorable efficacy and safety profiles, reinforced by consistent clinical data.
Regulatory and Patent Status
The patent for Eliquis expired in 2026, allowing for generic entry consequently. Patent expirations generally lead to price reductions and increased market penetration by generics.
Price Analysis
Brand Name Pricing Trends
As of Q1 2023, the average wholesale price (AWP) for Eliquis 5 mg tablets varies by purchase volume and payer type, with reported figures:
- Brand AWP: ~$500 per month supply (30 tablets of 5 mg, taken twice daily).
- Reimbursement Price: Around $300–$400 per month after negotiated discounts and rebates.
Generic Entry and Price Erosion
Post-patent expiry (anticipated in 2026), generic versions are projected to substantially lower per-unit costs:
- Generic Price: Estimated to be in the range of $15–$25 per 30-day supply, representing a decrease of 85–95% relative to brand-name prices.
Analogs from similar drug classes indicate that generic availability often reduces overall drug expenditure substantially, fostering broader accessibility.
Reimbursement and Insurance Dynamics
Payers negotiate significant discounts, particularly Medicaid and Medicare plans, which leverage their purchasing power. Pharmacy Benefit Managers (PBMs) further influence final prices through formulary management and rebate strategies, often securing rebates exceeding 20% of list prices.
Market Projections
Short-Term Outlook (2023–2025)
- Pricing Stability: Brand-name prices are expected to plateau as market approaches patent expiration.
- Market Share Dynamics: Prescriber preferences are likely to shift towards generics upon availability, with 60–70% of prescriptions expected to be filled generically within the first year.
- Volume Growth: Due to the increasing prevalence of atrial fibrillation and VTE, prescription volumes are expected to grow approximately 4–6% annually.
Medium to Long-Term Outlook (2026 and beyond)
- Price Decline: Generic competition will lower prices, making the drug more cost-effective.
- Market Penetration: Expected to capture a larger share among payers and healthcare systems due to affordability.
- Potential Biosimilar or Novel Formulations: Future innovations could influence pricing trajectories further.
Impact of Policy and Market Forces
Regulatory policies that promote biosimilar and generic adoption, such as the FDA’s generics approval pathway, will accelerate price erosion. Additionally, healthcare reforms emphasizing cost containment will pressure manufacturers to adjust pricing strategies.
Conclusion
NDC 00004-0259 occupies a significant position in the anticoagulant market, with current brand pricing influenced by market dominance and patent protections. The imminent entry of generics, beginning around 2026, is projected to result in profound price reductions, aligning costs with industry standards for similar drugs. Stakeholders should prepare for a transition toward more cost-effective therapies, balancing innovation, pricing strategies, and regulatory developments.
Key Takeaways
- Market Position: Eliquis remains a market leader in anticoagulants, driven by clinical efficacy and safety.
- Pricing Trajectory: Brand prices are stable currently but will decline sharply post-patent expiry.
- Generics Impact: Entry of generics in 2026 will reduce prices by approximately 85–95%.
- Future Trends: Increased adoption of generics and biosimilars will facilitate broader access and cost savings.
- Strategic Planning: Companies should prepare for market shifts via research, pipeline development, and pricing optimization.
FAQs
Q1: When will generic versions of NDC 00004-0259 become available?
A: Generic versions are anticipated to enter the market around 2026, following patent expiration.
Q2: How will the entry of generics affect drug prices?
A: Generics typically reduce prices by 85–95%, making therapy more affordable for payers and patients.
Q3: What factors influence the pricing of brand-name anticoagulants like NDC 00004-0259?
A: Factors include patent status, clinical efficacy, market demand, reimbursement negotiations, and competitor pricing.
Q4: Are there upcoming innovations that may influence the market for this drug?
A: Biosimilars, novel formulations, or new delivery methods could alter the competitive landscape post-2026.
Q5: How do regulatory policies impact drug pricing and market access?
A: Policies promoting biosimilar approval and generic substitution typically drive prices downward and expand access.
References
- IQVIA, 2022. Anticoagulant Market Analysis.
- U.S. Food & Drug Administration, 2023. Generic Drug Approvals.
- Medicare Payment Advisory Commission, 2023. Drug Price Trends and Policy Impacts.
- Pharmaceutical Research and Manufacturers of America (PhRMA), 2022. Innovation and Market Dynamics.
(Note: Specific details such as drug names and data points are for illustration. Actual analysis should incorporate current, detailed market intelligence for precision.)
