Last updated: February 27, 2026
What is NDC 00574-4031?
NDC 00574-4031 corresponds to Xarelto (rivaroxaban) 20 mg tablets, an anticoagulant prescribed for preventing and treating thromboembolic events such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke prevention in atrial fibrillation.
Market Size and Dynamics
Current Market Valuation
- The global rivaroxaban market was valued at approximately $4.2 billion in 2022.
- The United States accounts for over 40% of this market, driven by high prevalence of atrial fibrillation, DVT, and PE, along with extensive adoption of oral anticoagulants.
Market Drivers
- Growing incidence of atrial fibrillation in adults, reaching an estimated 5 million in the U.S. (source: CDC).
- Increasing awareness and diagnosis of venous thromboembolism.
- Preference for oral anticoagulants over injectable therapies due to convenience.
- Patent exclusivity periods, with generic versions entering the market post-2024.
Competition Landscape
Primary competitors include:
| Drug |
Mechanism |
Market Share (2022) |
Approval Date |
| Xarelto (rivaroxaban) |
Factor Xa inhibitor |
50% |
2011 (U.S.) |
| Eliquis (apixaban) |
Factor Xa inhibitor |
36% |
2012 |
| Pradaxa (dabigatran) |
Direct thrombin inhibitor |
10% |
2010 |
| Savaysa (edoxaban) |
Factor Xa inhibitor |
4% |
2015 |
Regulatory Status and Patent Outlook
- Labeling approved indications until 2027.
- Patent expiration for core formulations anticipated in 2024-2026, opening the market to biosimilars and generics.
Price Analysis and Trends
Current Pricing
| Dosage and Pack Size |
Average Wholesale Price (AWP) |
Estimated Out-of-Pocket Price |
| 20 mg, 30 tablets |
$850 per pack |
$25-$35 (with insurance) |
| Generic rivaroxaban (post-2024) |
~$300 per pack (estimated) |
$10-$15 (with insurance) |
Note: Prices vary by pharmacy and insurance plan.
Price Evolution
- Name-brand Xarelto pricing has declined by approximately 20-25% since 2018.
- Introduction of generics is projected to reduce prices by 50-65% from current brand levels post-2024.
Projections
Short-Term (Next 1-2 Years)
- Brand pricing remains relatively stable, given current patent protections.
- Anticipated price drop of 5-10% as competitors prepare for generic entry in late 2023 to early 2024.
- Market share may thin as payers preferentially cover generics.
Mid-Term (3-5 Years)
- Post-patent expiry, prices are projected to fall to $150-$200 per pack for brand formulations, with generics priced at $50-$100.
- Market volume expected to increase modestly due to expanded indications and clinician familiarity.
Long-Term (Beyond 5 Years)
- With biosimilars and multiple generics entering, prices could normalize around $50 per pack.
- Market growth will depend on the adoption rate of biosimilars and healthcare policy changes.
Summary
| Aspect |
Data Point |
| Market Size (2022) |
~$4.2 billion globally |
| US Market Share |
40+% |
| Major Competitors |
Eliquis, Pradaxa, Savaysa |
| Patent Expiry |
2024-2026 |
| Price Post-Entry |
$50-$100 for generics, $150-$200 for brand |
Key Takeaways
- NDC 00574-4031 (Xarelto 20 mg) commands a significant market share within anticoagulants.
- The upcoming patent expiration in 2024 will lead to substantial price reductions driven by generic competition.
- Market volume is expected to grow slightly due to expanded indications and increasing prevalence of thrombotic conditions.
- Pricing strategies should account for a rapid decline in prices over the coming years, influencing profitability and market entry timing.
FAQs
1. When will generics for rivaroxaban become available?
In the U.S., patents are expected to expire between 2024 and 2026, enabling generic entry.
2. How will generic entry impact the market?
Prices are projected to decline by about 50-65%, increasing accessibility and market volume.
3. What is the primary competition for Xarelto?
Eliquis (apixaban) leads in market share, with Pradaxa and Savaysa also competing.
4. Are there regulatory or policy factors influencing pricing?
Yes. Policies promoting biosimilars and generic drug adoption can accelerate price reductions.
5. How should companies plan for the post-patent landscape?
Developing biosimilars, optimizing cost structures, and expanding indications can sustain market share and profitability.
References
- MarketResearch.com. (2023). Global Anticoagulant Market Forecast.
- CDC. (2022). Atrial Fibrillation Statistics.
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Patent and Trademark Office. (2023). Patent expiration timelines.
- GoodRx. (2023). Drug Pricing Data.
