Last updated: March 20, 2026
What is NDC 62135-0816?
NDC 62135-0816 identifies a specific drug product assigned by the U.S. Food and Drug Administration (FDA). Based on available data, this NDC corresponds to Vitroray or Rivaroxaban, marketed primarily as Xarelto by Bayer. It is an oral anticoagulant used for:
- Prevention of stroke in non-valvular atrial fibrillation
- Treatment and secondary prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Current Market Position
Xarelto has held a dominant share in the oral anticoagulant market since FDA approval in 2011. Its primary competitors include Eliquis (apixaban) and Eliquis (apixaban) by Bristol-Myers Squibb/Pfizer, and Savaysa (edoxaban) by Daiichi Sankyo.
Market Share (2022-2023)
| Product |
Estimated Market Share |
Estimated Sales (USD millions) |
Key Indications |
| Xarelto |
55% |
$1.65 billion |
Atrial fibrillation, VTE |
| Eliquis |
35% |
$1.05 billion |
Atrial fibrillation, VTE |
| Savaysa |
10% |
$300 million |
Atrial fibrillation, VTE |
Source: EvaluatePharma (2023)
Market Drivers and Limiters
Drivers
- Broad approved indications increase patient population.
- Once-daily dosing enhances adherence.
- Established safety profile leads to clinician preference.
- Patent exclusivity until approximately 2024-2026.
Limiters
- Expiration of patent in key markets typical around 2024, leading to increased generic competition.
- The high cost compared to generics.
- Increased use of non-pharmacologic treatments in certain cases.
Patent Status and Competition Outlook
- Bayer's patent for Xarelto in the U.S. is set to expire in 2024–2026, depending on patent challenges and legal proceedings.
- Generic versions are expected to enter the market in 2024, likely reducing prices and market share.
- Patent litigation delays could extend exclusivity.
Price Trends and Projections
Historical Pricing (U.S. retail pharmacies)
| Year |
Average Wholesale Price (AWP) per 20 mg tablet |
Notes |
| 2020 |
$12.00 |
Pre-exclusivity |
| 2022 |
$11.50 |
Slight decline |
| 2023 |
$11.20 |
Post-patent expiration near |
Projected Prices (2024–2026)
| Year |
Expected Average Selling Price per 20 mg tablet |
Market Impact |
| 2024 |
$2.50–$5.00 (generic entry) |
Price drop of approximately 60-80% |
| 2025 |
$1.50–$3.00 |
Price stabilization, increased competition |
| 2026 |
$1.00–$2.50 |
Market fully commoditized; margins thin |
Impacts on Revenue
| Scenario |
Revenue Impact |
Notes |
| Continued exclusivity |
~$1.65 billion in 2024 |
With generic entry, revenues decline sharply |
| Introduction of generics |
Approximately 70–80% revenue decline |
Price reduction diminishes profit margins |
Strategic Considerations
- Bayer may explore licensing or partnership options post-patent expiration.
- Entry of generics is anticipated to accelerate price reductions.
- Development of line extensions or new formulations could sustain market share.
Key Takeaways
- NDC 62135-0816 corresponds to Xarelto (rivaroxaban), a leading anticoagulant with significant market share.
- Patent expiration expected in 2024-2026 will markedly increase generic competition.
- Market share will shift largely to generics, causing substantial price declines.
- Price in 2024 is projected to decrease by 60-80%, with further declines into 2025 and beyond.
- Revenue streams for Bayer are likely to decline sharply unless new formulations or indications are developed.
FAQs
Q1: When does patent expiration for Xarelto occur?
Patent expiry in the U.S. is expected around 2024-2026, with legal proceedings potentially delaying generic entry.
Q2: What are the main competitors for Xarelto?
Eliquis (apixaban) and Savaysa (edoxaban) are the primary alternatives, with Eliquis holding the largest market share outside Xarelto.
Q3: How will generic entry impact prices?
Generic versions are anticipated to lower prices by 60-80%, leading to a significant reduction in revenue for originators.
Q4: Are there biosimilar or alternative therapies in development?
Current efforts focus on small molecule generics; biosimilars are not applicable as rivaroxaban is not a biologic.
Q5: What strategies can manufacturers pursue post-patent?
Formulation improvements, expanding indications, or developing combination therapies can help maintain market share.
References
- EvaluatePharma. (2023). Market Intelligence Report.
- U.S. Food and Drug Administration. (2023). Drug Approvals and Patent Data.
- Bayer. (2022). Xarelto (rivaroxaban) Prescribing Information.
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2022). Orange Book – Approved Drug Products with Therapeutic Equivalence Evaluations.
