Last updated: February 15, 2026
What is the drug identified by NDC 00093-5246?
The National Drug Code (NDC) 00093-5246 corresponds to Arixtra (fondaparinux sodium), an anticoagulant indicated for deep vein thrombosis (DVT) and pulmonary embolism (PE) prevention in adult surgical and medical patients, as well as for treatment of DVT and PE [1].
Market Overview
Market size: The global anticoagulants market was valued at approximately $16 billion in 2021 and projected to reach $25 billion by 2027, growing at a compound annual growth rate (CAGR) of around 7.5% [2].
Key players: In addition to GSK’s Arixtra, main competitors include:
- Enoxaparin (Lovenox, Sanofi)
- Dalteparin (Fragmin, Pfizer)
- Rivaroxaban (Xarelto, Janssen)
- Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer)
- Edoxaban (Savaysa, Daiichi Sankyo)
Market dynamics: Arixtra holds a niche in high-risk, hospital-based anticoagulation. Its usage is declining relative to direct oral anticoagulants (DOACs), which offer oral administration, convenience, and similar efficacy.
Pricing Trends and Historical Data
Pricing as of latest data:
- The average wholesale price (AWP) for a 2.5 mg/0.5 mL vial (standard dose for prophylaxis) is approximately $90-$110 per unit.
- Treatment courses typically involve multiple doses, with inpatient protocols costing between $500 and $1,200 depending on duration.
Pricing trends:
- Since 2010, prices have remained relatively stable but face pressure due to patent expiry and emergence of generics.
- No generic version of fondaparinux sodium reached the market as of 2022, limiting downward price pressures.
Market Trends and Future Price Projections
Factors influencing future prices:
- Patent status: The original patent expired in 2010. However, regulatory data exclusivity effectively delayed generic entry until approximately 2020.
- Generics: No generic fondaparinux has been approved; once approved, price reductions are expected, typically ranging from 30–50%.
- Competitive landscape: Increasing adoption of DOACs exerts downward pricing pressures.
- Reimbursement policies: Payers favor oral anticoagulants; inpatient injectables face reimbursement challenges.
Projected trajectory:
- Over the next 3 years, prices for branded Arixtra may decline by 10–15% due to market saturation and competitive pressures [3].
- If a generic version enters the market, prices could fall by 40–50% within 2 years.
- The average price per treatment course (assuming 5 doses) may drop to below $100, approaching $60–70 with generic competition.
Potential Impact of Regulatory and Market Factors
- Regulatory approvals: Approval of biosimilars or generics would prompt rapid price declines.
- Market share shifts: The increasing use of DOACs may limit growth prospects for injectable agents like fondaparinux.
- Hospital economics: Cost-containment measures may favor lower-cost alternatives, impacting sales of branded Arixtra.
Summary of Price Projections (Next 3 Years)
| Scenario |
Price Change |
Estimated Price per Course |
Notes |
| Status quo (no generic entry) |
-10 to -15% |
$80–$100 |
Slight decline due to market saturation |
| With generic entry |
-40 to -50% |
$40–$60 |
Rapid erosion of premium pricing |
Key Takeaways
- The Arixtra market is mature, with no generic versions currently available.
- Prices are stable but face downward pressure if generics or biosimilars gain approval.
- Adoption of oral anticoagulants lessens the growth of injectable drugs like fondaparinux.
- Inpatient usage drives revenue but is constrained by reimbursement shifts toward oral agents.
- Price declines of 10–50% are anticipated depending on market dynamics and regulatory changes.
FAQs
1. What factors could accelerate the entry of generics for fondaparinux?
Regulatory hurdles and complex manufacturing processes have historically delayed generics; if these are overcome, entry could occur within 1-2 years, significantly lowering prices.
2. How does the price of Arixtra compare to other anticoagulants?
Arixtra costs approximately $90-$110 per dose, similar to low-dose enoxaparin but significantly more expensive than many DOACs, which can cost $3-$10 per dose.
3. Is Arixtra likely to maintain market share?
Market share will decline unless positioned for niche uses. Preferred agents are moving toward oral DOACs for convenience and cost reasons.
4. How do reimbursement trends affect the future pricing of Arixtra?
Payers prefer oral anticoagulants; reimbursement policies favor lower-cost alternatives, compressing profit margins for injectable agents.
5. What does the future hold for Arixtra in the hospital setting?
Usage will remain in high-risk or specific clinical scenarios but will diminish with broader adoption of DOACs and potential generic versions.
References
[1] GSK. Arixtra (fondaparinux sodium) prescribing information. 2022.
[2] MarketsandMarkets. Anticoagulants Market by Type, Application, and Region. 2022.
[3] IQVIA. U.S. Pharmaceutical Market Data. 2022.
