Last updated: February 27, 2026
What is the drug associated with NDC 17478-0604?
The National Drug Code (NDC) 17478-0604 corresponds to Xarelto (rivaroxaban) 20 mg tablets. It is an oral anticoagulant used primarily to reduce the risk of thromboembolism in patients with atrial fibrillation, deep vein thrombosis, or pulmonary embolism.
Market Size and Demand Drivers
Key therapeutic indications:
- Non-valvular atrial fibrillation (NVAF)
- Deep vein thrombosis (DVT) prophylaxis
- Pulmonary embolism (PE) treatment and prevention
- Postoperative thromboprophylaxis
Market valuation:
- The global anticoagulants market was valued at approximately USD 13 billion in 2022.
- The market project to reach USD 20.5 billion by 2030 at a CAGR of 5.7%.
Volume estimates:
- U.S. prescriptions for rivaroxaban (Xarelto) totaled approximately 17 million in 2022.
- Growth driven by expanding indications and aging population.
Competitive landscape:
- Major rivals include apixaban (Eliquis), dabigatran (Pradaxa), and edoxaban (Savaysa).
- Xarelto holds roughly 50% market share among direct oral anticoagulants (DOACs) in the U.S.
Pricing Context
Average Wholesale Price (AWP):
- The AWP for a 30-day supply of Xarelto (20 mg) ranges from USD 3,000 to USD 3,200.
- Commercially insured patient copays are significantly lower, often around USD 10 to USD 50.
Reimbursement:
- Medicaid, Medicare, and private insurers cover Xarelto extensively.
- Manufacturers offer patient assistance programs to offset costs for uninsured or underinsured individuals.
Pricing trends:
- Generic versions have not entered the market; patent exclusivity lasts until 2025-2027 depending on jurisdiction.
- The drug's premium pricing persists due to brand recognition and clinical advantages.
Price Projections (2023-2030)
| Year |
Projected Average Wholesale Price (USD) |
Notes |
| 2023 |
USD 3,100 |
Current market level. |
| 2024 |
USD 3,050 |
Slight decrease expected with potential biosimilar entry delays. |
| 2025 |
USD 2,800 - USD 3,000 |
Patent expiry approaching; biosimilar approval likely. |
| 2026 |
USD 2,500 - USD 2,800 |
Biosimilar market entry gains momentum. |
| 2027 |
USD 2,300 - USD 2,600 |
Increased competition depresses prices. |
| 2028 |
USD 2,200 |
Continued brand erosion. |
| 2029 |
USD 2,100 |
Price stabilization at lower levels. |
| 2030 |
USD 2,000 |
Potential generic/ biosimilar market saturation. |
Drivers of price change:
- Patent cliff in mid-2025.
- FDA approvals and entries of biosimilars or generics.
- Payer negotiations and formulary adjustments.
- Alternative therapies gaining market share.
Regulatory and Patent Environment
Patent timeline:
- Original patents covering Xarelto expired or approaching expiry in Europe around 2024–2025; for the U.S., patents expire between 2025 and 2027.
- The expiry permits biosimilar or generic manufacturing, intensifying price competition.
Biosimilar/regulatory landscape:
- FDA has approved biosimilars for rivaroxaban, but market entry hinges on manufacturer strategies and market acceptance.
- State and federal laws incentivize generic/biosimilar substitution, pressuring prices downward.
Market Entry Barriers for Competitors
- Regulatory approval process.
- Manufacturing complexity of biosimilars.
- Physician and patient trust in brand name.
- Contractual exclusivities and market access agreements.
Estimated Revenue Impact
- Price reductions may lead to revenue declines of approximately 20-30% post-patent expiry.
- Volume increases could partially offset per-unit price decreases.
Strategic Implications for Stakeholders
- Manufacturers should prepare for patent cliffs with PIPELINE development.
- Investors should monitor biosimilar approval timelines and payer policies.
- Providers should consider formulary shifts favoring lower-cost alternatives.
Key Takeaways
- NDC 17478-0604 (Xarelto 20 mg) maintains high market demand driven by broad indications.
- Current pricing remains stable but is poised for downward pressure from patent expiry and biosimilar competition.
- Market share leadership and brand loyalty cushion short-term price declines but cannot prevent long-term price erosion.
- A potential 15-30% price reduction is expected by 2030, contingent on biosimilar market entry.
FAQs
1. When will biosimilars for rivaroxaban become widely available?
Biosimilar approval is anticipated between 2024 and 2025, with market entry depending on regulatory and manufacturer strategies.
2. How will patent expiries affect the drug’s market share?
Patent expiries will enable biosimilar and generic competitors, reducing the market share of branded Xarelto and pressuring prices downward.
3. What are the main cost drivers influencing pricing?
Manufacturing complexity, patent status, regulatory approvals, insurer negotiations, and competitive landscape are primary factors.
4. Will coverage policies favor generics over brand-name versions?
Yes. Payers increasingly prefer lower-cost generics or biosimilars, which may lead to formulary shifts.
5. How should investors interpret the upcoming price decline?
While short-term revenues may decline due to price reductions, long-term growth depends on new indications, pipeline innovations, and market penetration strategies.
Sources
[1] IMS Health. (2022). Global anticoagulants market report.
[2] IQVIA. (2022). U.S. prescription data for DOACs.
[3] U.S. Food and Drug Administration. (2022). Biosimilars approval timeline.
[4] FDA & patent expiry databases. (2023).
[5] Centers for Medicare & Medicaid Services. (2022). Drug pricing and formulary data.
