Last updated: February 27, 2026
What is NDC 00378-8688?
NDC 00378-8688 identifies a specific pharmaceutical product, which is the Eliquis (apixaban) 2.5 mg tablet. Eliquis is an anticoagulant indicated primarily for stroke prevention in non-valvular atrial fibrillation and treatment of thromboembolic events.
Market Overview
Market Size
Eliquis (apixaban) is a leading product in the direct oral anticoagulant (DOAC) market, which grew substantially over the past five years. The global anticoagulant market was valued at approximately USD 7.3 billion in 2021 and is projected to reach USD 10.7 billion by 2028, with a compound annual growth rate (CAGR) of around 5.5%.[1]
Competition Landscape
Eliquis faces competition from other DOACs:
- Xarelto (rivaroxaban) by Bayer/Janssen
- Pradaxa (dabigatran) by Boehringer Ingelheim
- Savaysa (edoxaban) by Daiichi Sankyo
Market share distributions in 2022 place Eliquis at roughly 30-35% of total anticoagulant prescriptions, making it the top-selling DOAC.[2]
Regulatory Approvals and Recent Developments
Eliquis holds approvals across major markets:
- United States (FDA)
- European Union (EMA)
- Japan
Recent approval extensions include:
- Additional indications in venous thromboembolism (VTE) treatment
- Use in pediatric populations (ongoing trials)
Price Dynamics
Current Pricing
Retail pricing varies by formulation and dispensing setting:
- Brand-name Eliquis (per tablet): Approx. USD 15-20
- Generic versions: Approximately 10-12 per tablet, following patent expiry in 2026
In the United States, the average wholesale price (AWP) for Eliquis 2.5 mg tablet is USD 16.50.[3]
Reimbursement and Formularies
Insurance coverage significantly impacts patient access:
- Major insurers list Eliquis at tier 2, with co-pays averaging USD 10-15
- Some hospitals and clinics prefer generics, affecting pricing power
Price Trends
- Pre-patent expiry: Eliquis maintained premium pricing (~USD 20), supported by patents and exclusivity.
- Post-patent expiry (expected 2026): Prices are predicted to drop by about 40-50%, aligning with historical generic entry patterns.
Factors Influencing Future Prices
- Entry of generics after patent expiration
- Negotiations with payers and pharmacy benefit managers (PBMs)
- Development of biosimilars and competing formulations
- Regulatory changes affecting drug importation and compounding
Cost and Revenue Projections
Market Penetration
In the U.S., Eliquis's prescription volume increased from approximately 5 million prescriptions in 2020 to over 7 million in 2022.[4] With patent expiry approaching, penetration is expected to plateau as generic competition enters the market.
Revenue Estimates (2023-2028)
| Year |
Estimated Sales (USD millions) |
Key Assumptions |
| 2023 |
8,500 |
High brand monologue with premium pricing |
| 2024 |
8,000 |
Slight decline as generics enter |
| 2025 |
7,000 |
Patent expiry imminent, generic launches |
| 2026 |
3,500 |
Generic market penetration begins |
| 2027 |
2,000 |
Further price reductions and volume shifts |
| 2028 |
1,500 |
Market stabilization at lower margins |
Price Adjustment Expectations
- Pre-patent expiry: Maintains premium pricing (~USD 16-20 per tablet)
- Post-patent expiry: Price reduction by approximately 45-50%, leading to generic pricing (~USD 8-10 per tablet)
Strategic Considerations
- Patent litigation: Any extension or challenge could delay generic entry.
- Market share shifts: Key players and payers will influence pricing consistency.
- Emerging therapies: New anticoagulants or alternative modalities may impact market growth and pricing power.
Key Takeaways
- NDC 00378-8688 (Eliquis 2.5 mg) is dominant in the anticoagulant market, with significant sales volume and high prevalence of use.
- Price per tablet is currently around USD 15-20 in the U.S., with potential declines following patent expiry in 2026.
- The total market size for anticoagulants is expanding, driven by aging populations and the increasing incidence of atrial fibrillation.
- Post-patent entry of generics is expected to reduce prices significantly, impacting revenue projections.
- Competitive dynamics and regulatory changes will influence market share and pricing strategies.
FAQs
1. When is Eliquis's patent set to expire?
Patent expiration is expected in 2026, followed by generic entry.
2. How will generic entry impact Eliquis's market share?
Generics could capture over 80% of prescriptions within 2 years of launch, leading to sharp price reductions.
3. Are there approved biosimilar versions of Eliquis?
No, as Eliquis is a small-molecule drug; biosimilar classifications do not apply.
4. What are the main drivers of growth in the anticoagulant market?
Aging populations, increased diagnosis of atrial fibrillation, and expanded approvals for new indications.
5. How do reimbursement policies influence drug prices?
Insurance and PBMs' formulary negotiations can restrict prices and determine co-insurance levels.
References
[1] Grand View Research. (2022). Global Anticoagulant Market Size, Share & Trends.
[2] IQVIA. (2022). Prescription Data for Anticoagulants.
[3] Red Book. (2023). Wholesale Price Reporting Service.
[4] Express Scripts. (2022). Medication Utilization Data.
Note: Data are estimates based on industry reports, regulatory filings, and market analyses as of early 2023.
