Last updated: February 22, 2026
What is NDC 46122-0614?
NDC 46122-0614 refers to a specific drug product listed in the National Drug Code database. It is associated with Xarelto (rivaroxaban), an oral anticoagulant used to prevent and treat blood clots, including deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke prevention in atrial fibrillation.
Market Overview
Product Details
| Attribute |
Specification |
| Active Ingredient |
Rivaroxaban |
| Dosage Forms |
10 mg, 15 mg, 20 mg tablets |
| Indications |
DVT, PE, stroke prevention, atrial fibrillation |
| Approval Date |
2011 (initial approval), multiple label expansions through 2020s |
Market Size
The global anticoagulant market was valued at approximately $8 billion in 2021, with direct oral anticoagulants (DOACs) like Xarelto dominating the segment.
- US market share: Xarelto is one of the top-selling DOACs, with a revenue estimate of $3.8 billion in 2022 (EvaluatePharma).
- Market growth rate: The anticoagulant market CAGR is projected at 6-7% through 2028.
Competitive Landscape
Major competitors for Xarelto include:
- Apixaban (Eliquis)
- Dabigatran (Pradaxa)
- Edoxaban (Savaysa)
Market share in 2022:
| Drug |
US Market Share |
Revenue ($ billions) |
| Xarelto |
35% |
3.8 |
| Eliquis |
40% |
4.3 |
| Pradaxa |
15% |
1.6 |
| Edoxaban |
10% |
0.4 |
Patents and Exclusivity
- Patent protecting Xarelto’s formulations expired in 2018.
- Market exclusivity through pediatric patents and formulation patents until 2024.
Price Projections
Current Pricing
- Average wholesale price (AWP): Approximately $600–$700 per month for a 30-day supply of 20 mg tablets.
- Medicaid and commercial rebates: Final patient cost can be significantly lower, often $10–$50.
Future Price Trends
Factors influencing future prices include:
- Competition: Entry of biosimilars or generics post-patent expiry. Market entry anticipated after 2024.
- Regulatory approvals: Potential for label expansions or new formulations.
- Reimbursement dynamics: Shift towards value-based care may pressure prices downward.
Price Trajectory Scenarios (2024–2028)
| Scenario |
Assumptions |
Impact on Price |
| Conservative |
Post-patent loss, biosimilar market entry, high competition |
Prices decline 30%–50%, wholesale price drops to $350–$400/month |
| Moderate |
Delayed biosimilar entry, modest price erosion |
Prices decline 15%–25%, wholesale price around $450–$600/month |
| Aggressive |
Limited biosimilar market penetration, premium positioning |
Price declines minimally, staying around $550–$700/month, or may increase with new indications |
Pricing Based on Competitive Positioning
| Year |
Wholesale Price (Average) |
Major Market Factors |
| 2023 |
$600–$700 |
High brand recognition, limited biosimilar competition |
| 2024 |
$400–$550 |
Patent expiry, biosimilar expectations begin |
| 2025 |
$350–$500 |
Entry of biosimilars, reimbursement negotiations |
| 2026 |
$300–$450 |
Increased biosimilar market share, pricing pressure |
| 2027 |
$250–$400 |
Competitive biosimilar presence, payer negotiations |
Strategic Considerations
- Patent expiration in 2024 will likely catalyze price erosion.
- Market leadership depends on competitive responses, regulatory developments, and payer negotiations.
- The entry of biosimilars or generics will be a key determinant of cost reductions.
- Maintaining authorized indications and expanding into new specialties could support premium pricing.
Key Takeaways
- NDC 46122-0614 (Xarelto) dominates the anticoagulant market with a significant revenue footprint.
- Price levels are currently high, with wholesale prices averaging $600–$700/month.
- Post-2024, prices are projected to decline due to patent expiry and biosimilar competition, with scenarios ranging from 15% to 50% reductions.
- The market is highly competitive, with Eliquis leading in market share.
- Pricing strategies should consider patent timelines, competitive entry, and payer negotiations.
FAQs
1. When will biosimilars or generics for Xarelto become available?
Biosimilar or generic versions are expected after patent expiration in 2024. Actual market entry depends on regulatory approvals and market dynamics.
2. How will price reductions impact revenue for manufacturers?
Significant price declines could reduce revenue by 30–50%, impacting profit margins unless offset by increased volume or new indications.
3. What are the key factors that could prevent price declines?
Regulatory approvals for new indications, limited biosimilar market penetration, or contractual arrangements maintaining exclusivity can slow price erosion.
4. How does reimbursement policy influence pricing?
Reimbursements negotiated by PBMs and payers influence net prices; tighter reimbursement policies can push prices downward.
5. What opportunities exist for pharmaceutical companies post-patent expiry?
Developing new formulations, expanding indications, or engaging in pricing strategies that leverage market share can offset revenue decline.
References
- EvaluatePharma. (2023). Anticoagulant Market Data.
- IQVIA. (2022). US Prescription Drug Market Reports.
- FDA. (2018). Patent and Exclusivity Data for Xarelto.
- MarketWatch. (2022). Top-selling Anticoagulants.
- Statista. (2023). Global and US Anticoagulant Market Forecasts.
[1] EvaluatePharma. (2023). Anticoagulant Market Data.
