Last updated: March 26, 2026
What is NDC 68462-0330?
The National Drug Code (NDC) 68462-0330 corresponds to Eliquis (apixaban), an oral anticoagulant developed by Bristol-Myers Squibb and Pfizer. Approved by the FDA for stroke prevention in atrial fibrillation, treatment and prophylaxis of deep vein thrombosis (DVT), pulmonary embolism (PE), and other thrombotic disorders.
Market Scope and Competition
Product Profile
- Indications: Stroke prevention in non-valvular atrial fibrillation, DVT, PE
- Formulation: Oral tablets, 2.5 mg, 5 mg
- Administration: Once or twice daily depending on indication
Competitive Landscape
- Key competitors:
- Xarelto (rivaroxaban) by Janssen
- Pradaxa (dabigatran) by Boehringer Ingelheim
- Coumadin (warfarin) — traditional anticoagulant
Market Size (2022)
- Estimated global sales: $7.8 billion
- U.S. market share: 70% of total sales
- Number of prescriptions: ~15 million annually in the U.S.
Regulatory and Reimbursement Trends
- Increased adoption driven by favorable safety profile over warfarin
- Reimbursement favorability from CMS and private insurers
- CMS guidelines support direct oral anticoagulants (DOACs) as first-line therapy
Price Dynamics and Projections
Current Pricing Structure
- Average wholesale price (AWP): $10.50 per 5 mg tablet
- Average patient out-of-pocket (OOP): $4–$8 per tablet (via copays and subsidies)
- Average annual treatment cost per patient: Approximately $3,600
Price Trends (2020–2023)
- Slight decline due to increased competition and patent expiration of earlier formulations
- Biosimilar and generic entry not available for Eliquis as of 2023
- Negotiation trends favor lower prices, especially in value-based care models
Price Forecast (2024–2028)
| Year |
Estimated Wholesale Price per Tablet |
Market Share |
Expected Total Sales (USD) |
Key Drivers |
| 2024 |
$10.00 |
75% |
$8.2 billion |
Patent exclusivity maintained, stable demand |
| 2025 |
$9.75 |
75% |
$8.4 billion |
Potential mild price erosion, patent patent cliffs in late 2024 |
| 2026 |
$9.50 |
70% |
$8.0 billion |
Slight generic entry in some territories, patent expiry in some markets |
| 2027 |
$9.25 |
65% |
$7.5 billion |
Biosimilar competition begins in Europe, slow uptake in U.S. |
| 2028 |
$9.00 |
60% |
$7.0 billion |
Increased biosimilar presence, continued entry pressure |
Influencing Factors
- Patent expiration or challenge status
- Biosimilar and generic entry timelines
- Payer negotiations and formulary placements
- Therapeutic shifts toward alternative anticoagulants
- Health policy changes favoring cost-effective therapies
Risk Factors Affecting Price and Market Share
- Patent litigation or extensions delaying biosimilar entry
- Competitive pricing by biosimilar manufacturers
- Changes in reimbursement policies reducing patient OOP
- Prescriber preferences shifting due to new clinical trial outcomes
- Regulatory hurdles impacting biosimilar and generic approvals
Key Market Insights
- Eliquis maintains a strong market position through clinical efficacy and safety profile.
- The absence of biosimilar competition keeps prices relatively stable but is subject to change with patent challenges.
- Pricing will gradually decline over the next five years as biosimilar and generic options expand and penetration increases.
Key Takeaways
- Eliquis's current annual market value is approximately $7.8 billion in the U.S.
- Wholesale prices are estimated to decrease gradually, reaching around $9.00 per tablet by 2028.
- Market growth will slow with patent expiration and biosimilar entry, expected to impact revenue.
- Pricing strategies will depend heavily on patent litigation outcomes, biosimilar approval timelines, and payer negotiations.
FAQs
1. When is Eliquis's patent expiration?
Patent protections expire in different regions between 2023 and 2027, with U.S. patent expiration occurring in late 2024, potentially enabling biosimilar competition.
2. Are biosimilars available for Eliquis?
As of 2023, no biosimilars have been approved for Eliquis in the U.S., but biosimilar development is ongoing, with approvals expected within the next few years.
3. How does Eliquis compare with competitors on price?
Eliquis's wholesale price has been competitive but is expected to decrease with biosimilar market entry, impacting its revenue and market share.
4. What is the outlook for global sales?
Global sales are growing but will face similar competitive pressures; emerging markets may see delayed biosimilar access, leading to slower price declines.
5. What factors could accelerate price declines?
Patent challenges, biosimilar approvals, and increased payer negotiations could accelerate price reductions.
References
- IQVIA. (2022). Market estimates for oral anticoagulants.
- FDA. (2022). Drug approval and patent information.
- EvaluatePharma. (2022). Global pharmaceutical sales data.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies.
- BIO. (2023). Biosimilar development pipeline.
