Last updated: February 24, 2026
What is the drug represented by NDC 00054-3532?
NDC 00054-3532 corresponds to Xarelto (rivaroxaban), 20 mg, a direct oral anticoagulant (DOAC) licensed for prevention and treatment of thromboembolic events, including deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke prevention in atrial fibrillation (AFib).
Current Market Landscape
Market Size and Segmentation
- Global anticoagulant market was valued at ~$6.1 billion in 2022.
- Xarelto's market share is estimated at approximately 30% among DOACs, making it a leading product.
- US market share accounted for approximately 40% of global sales in 2022.
Key Competitors
| Drug |
Company |
Indications |
2022 US Sales |
Price per Dose (Approximate) |
| Apixaban (Eliquis) |
Bristol-Myers Squibb/Pfizer |
Stroke prevention in AFib, DVT/PE treatment |
$7.4B |
$5.20 (20 mg) |
| Dabigatran (Pradaxa) |
Boehringer Ingelheim |
DVT/PE treatment, AFib stroke prevention |
$1.4B |
$4.90 (150 mg) |
| Edoxaban (Savaysa) |
Daiichi Sankyo |
DVT/PE, AFib |
Limited |
$3.80 |
| Rivaroxaban (Xarelto) |
Bayer |
DVT/PE, AFib, post-ortho VTE |
$8.2B |
$5.30 (20 mg) |
Market Drivers
- Elevated prevalence of atrial fibrillation, DVT, and PE.
- Physician preference for convenience of oral administration.
- Extensive clinical trial data demonstrating efficacy.
Regulatory Status
- Approved in over 130 countries.
- US FDA approval since 2011.
- Patent exclusivity until 2024/2025; generic entries expected thereafter.
Price Trends and Projections
Historical Price Data
- Average wholesale price (AWP) for 20 mg rivaroxaban was around $6.50 per dose in 2019.
- In 2022, the average retail price increased to approximately $5.30 per dose, driven by brand rationalization and increased demand.
Near-term Price Projections (2023-2025)
- Patent expiry projected for 2024, which suggests a significant price decline upon generic entry.
- Generic entrance price estimated at 50-70% of current brand price, i.e., $2.50 - $3.50 per dose.
- Brand price可能 stabilize or slightly decline pre-expiry due to increased competition and market saturation.
| Year |
Estimated Brand Price per Dose |
Estimated Generic Price per Dose |
| 2023 |
$4.80 – $5.20 |
$2.80 – $3.50 |
| 2024 |
$4.50 – $5.00 |
$2.50 – $3.00 |
| 2025 |
$4.20 – $4.80 |
$2.00 – $2.50 |
Impact of Generics and Biosimilars
- Introduction of generics could lead to a 50-60% price reduction.
- Insurance coverage, drug formulary preferences, and hospital procurement strategies may influence actual market prices.
Market Expansion Opportunities
- Long-term care and outpatient settings remain primary markets.
- New indications pending approval, including extended thromboprophylaxis, could expand revenue streams.
- Biosimilars and potential me-too drugs pose competitive threats.
Key Takeaways
- Xarelto remains a dominant anticoagulant with approximately 30% global market share.
- The current US retail price is roughly $5.30 per dose for 20 mg tablets.
- Patent expiration around 2024 expects to catalyze significant price reductions with generic entry.
- Total US sales for rivaroxaban were roughly $8.2 billion in 2022, with continued growth driven by expanding indications and aging populations.
- Competitive landscape includes established alternatives with similar efficacy but varying costs and dosing regimens.
FAQs
1. When will generic rivaroxaban enter the market?
Patent exclusivity is expected to expire around 2024, enabling generic manufacturers to seek approval and commercialization.
2. How much will the price decline after generic entry?
Prices are projected to decrease by approximately 50% to 60%, aligning with historical trends observed in similar drugs.
3. What factors could influence pricing beyond patent expiry?
Insurance formulary policies, physician prescribing patterns, and regulatory decisions on biosimilars or alternative therapies.
4. How does Xarelto compare to competitors in terms of market share?
It holds about a 30% share globally, with Apixaban (Eliquis) leading at roughly 35%. Pricing and clinical preferences influence this landscape.
5. Are there ongoing clinical trials that might expand Xarelto’s indications?
Yes, multiple trials explore extended thromboprophylaxis and stroke prevention in additional patient populations, potentially increasing usage.
References
[1] IQVIA. (2022). Pharmaceutical Market Data & Insights.
[2] Bayer. (2022). Xarelto (rivaroxaban) US Prescribing Information.
[3] EvaluatePharma. (2022). World Preview 2027: Market Forecasts.
[4] U.S. FDA. (2011). Approval of Xarelto for Multiple Indications.
[5] MarketScreener. (2022). Anticoagulants Market Trends and Competitive Dynamics.
