Last updated: February 25, 2026
What is NDC 65862-0215?
NDC 65862-0215 refers to a specific pharmaceutical product, identified by the National Drug Code (NDC) number. This code designates a drug manufactured by a particular company, with details such as dosage form, strength, and packaging specific to the product.
Based on publicly available data, NDC 65862-0215 is associated with Xarelto (rivaroxaban) 20 mg tablets in a blister pack, produced by Janssen Pharmaceuticals. This medication is an oral anticoagulant indicated for conditions including deep vein thrombosis, pulmonary embolism, atrial fibrillation, and postoperative thromboprophylaxis.
Market Size and Trends
Global and U.S. Market Dynamics
| Aspect |
Data |
Source |
| U.S. market value for rivaroxaban (2019-2022) |
$2.5 billion in 2022, compound annual growth rate (CAGR) of 7.2% |
IQVIA, 2023[1] |
| Global market forecast (2023-2028) |
$6.5 billion by 2028, CAGR 8.0% |
Grand View Research, 2023[2] |
| Major competitors |
Eliquis (apixaban), Pradaxa (dabigatran), Warfarin |
EvaluatePharma, 2023[3] |
Key Drivers
-
Increasing prevalence of atrial fibrillation and venous thromboembolism.
-
Rapid adoption of direct oral anticoagulants (DOACs) over warfarin due to improved safety profile.
-
Expanded indications supported by recent clinical trials and label updates.
Market Challenges
-
Patent expiration risks looming around 2025, which could impact pricing and market share.
-
Competitive pricing from biosimilars and generic formulations.
-
Regulatory scrutiny on safety concerns related to bleeding risks.
Price Analysis
Current Price Point
As of Q1 2023, average wholesale price (AWP) for Xarelto 20 mg tablets in the U.S. is approximately $10.50 per tablet. The typical prescribed regimen involves one tablet daily, resulting in approximately $315/month per patient.
The Medicaid outpatient drug rebate program significantly lowers net prices, which are estimated at roughly 45-55% of AWP.
Price Trends and Projections
| Year |
Estimated Wholesale Price per Tablet |
Notes |
| 2023 |
$10.50 |
Current pricing based on major PBM and pharmacy pricing surveys |
| 2024 |
$10.40 |
Slight decline expected due to competitive pressures |
| 2025 |
$9.80 |
Potential dip with patent expiry and increased generic availability |
| 2026-2030 |
$8.50 - $9.00 |
Continued decline with increase in generic market share |
Factors Influencing Pricing
-
Patent expiry scheduled for 2025 could lead to generic rivaroxaban entering the market, lowering prices.
-
Contract negotiations with pharmacy benefit managers (PBMs) typically drive discounts.
-
New labeling indications or safety data can impact pricing dynamics.
Competitive Landscape & Pricing Impact
| Competitor |
Indications |
Current Price (Approx.) |
Market Share |
Patent Status |
| Eliquis (apixaban) |
Atrial fibrillation, VTE |
$10.75/tablet |
50% of DOAC market |
Patent until 2030 |
| Pradaxa (dabigatran) |
Similar indications |
$9.75/tablet |
12% |
Patent expired, generic available in 2015 |
The entry of generics is projected to reduce rivaroxaban prices by 25-40% within two years of patent expiration[4].
Revenue Projections Post-Patent Expiry
| Year |
Estimated Market Share |
Estimated Revenue (USD Billions) |
Assumptions |
| 2023 |
45% |
$2.2 billion |
Based on current market share and pricing |
| 2024 |
40% |
$1.8 billion |
Slight decline due to competitive pressure |
| 2025 |
30% |
$1.2 billion |
Patent expiry triggers generic entry |
| 2026 |
20-25% |
$0.8-$1.0 billion |
Post-generic market stabilization |
Regulatory and Policy Impact
-
The FDA approved the first generic rivaroxaban in 2020, with multiple manufacturers now active.
-
Price caps or negotiation policies under the Inflation Reduction Act could influence net pricing in subsequent years.
Summary
NDC 65862-0215 (Xarelto 20 mg) is positioned within a highly competitive anticoagulant market experiencing steady growth fueled by increasing indications. Current U.S. wholesale prices hover around $10.50 per tablet, with expectations of a gradual decline driven by patent expiration and entry of generics by 2025.
Post-patent expiration, mixture of pricing pressures and increased availability of generics are expected to decrease prices by 25-40%. Revenue projections reflect market share declines following generic entry but maintain significant commercial value through volume-based sales.
Key Takeaways
-
The anticoagulant market is projected to reach over $6.5 billion globally by 2028.
-
Price reductions of 25-40% are anticipated with generic competition starting after 2025.
-
Market share shifts from branded to generic rivaroxaban exert downward pressure on prices.
-
The ongoing safety profile and labeling updates influence market dynamics and pricing.
-
Payers and providers seek sustainable pricing models amid increasing competition.
FAQs
Q1: When will generic versions of rivaroxaban become available?
A1: Patent expiry in 2025 typically permits generic entry, with market availability expected shortly thereafter.
Q2: How much can prices decrease after patent expiration?
A2: Prices may decline by 25-40% due to increased generic competition.
Q3: What is the main competitor to NDC 65862-0215 in the U.S.?
A3: Eliquis (apixaban) is the leading competitor with approximately 50% of the DOAC market share.
Q4: How do rebates and discounts affect the actual price paid by payers?
A4: Rebates reduce net prices by approximately 45-55% from the AWP for Medicaid and commercial payers.
Q5: Are there regulatory risks impacting this drug?
A5: Safety concerns related to bleeding risks exist, but current FDA labeling supports continued use. Future safety data or regulatory actions could influence demand and pricing.
References
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] Grand View Research. (2023). Global Anticoagulant Market Size & Trends.
[3] EvaluatePharma. (2023). Top Market Share and Competitive Analysis.
[4] IMS Institute for Healthcare Informatics. (2017). The Impact of Generic Entry on Drug Prices.
