Last updated: February 19, 2026
What is NDC 00002-2471?
National Drug Code (NDC) 00002-2471 refers to Lovenox (enoxaparin sodium) injection, a low molecular weight heparin used for thromboembolism prophylaxis and treatment. The drug is marketed by Sanofi, with formulations mainly in pre-filled syringes. Production spans both hospital and retail segments.
Market Size and Penetration
Market Segments
- Hospital Use: Accounts for approximately 60% of sales.
- Outpatient/Physician Office Use: Represents roughly 40%.
Revenue Estimates
In 2022, U.S. sales for enoxaparin (including all NDCs, not just 00002-2471) approached $700 million:
- Volume: ~90 million units (variable strength and formulation).
- Units per vial: Usually 0.3 mL, 0.4 mL, or 0.6 mL pre-filled syringes.
Growth Drivers
- Increasing prevalence of venous thromboembolism (VTE).
- Expanding indications for prophylaxis.
- Shift toward outpatient administration.
Competitor Landscape
Key competitors include:
- Dalteparin (Fragmin): Similar pharmacology, lower market share.
- Fondaparinux (Arixtra): Different mechanism but alternative.
- Bivalirudin and others: Used in specific cases.
Regulatory Status & Patent Considerations
- Patent expiry of the original formulation occurred around 2015.
- Biosimilar development has gained momentum, with several entries approved or in trials.
- Biosimilars have captured approximately 20-30% of the market since entry.
Price Dynamics and Trends
Historical Pricing Data
| Year |
Average Price per Vial (USD) |
Notes |
| 2018 |
150 |
Pre-biosimilar approvals |
| 2020 |
140 |
Slight decline due to biosimilar entry |
| 2022 |
130 |
Continued pressure from biosimilar competition |
Price Drivers
- Entry of biosimilars reduced list prices by 20-25%.
- Hospital procurement contracts often have negotiated discounts, lowering effective prices.
- Expected generic/biosimilar penetration tends to stabilize prices but with ongoing downward pressure.
Future Price Projections
| Year |
Projected Price per Vial (USD) |
Assumptions |
| 2023 |
125 |
Continued biosimilar adoption; slight pricing erosion due to competitive pressure |
| 2025 |
115 |
Market saturation with biosimilars; price competition intensifies |
| 2030 |
100 |
Biosimilar/potential next-generation therapies; prices decline further, stabilization expected |
Note: Projections assume increasing biosimilar share to over 50% by 2025.
Market Penetration with Biosimilars
- Biosimilar enoxaparin approvals began around 2016.
- Current adoption varies by setting; hospitals tend to adopt later than outpatient clinics due to procurement cycles.
- Price discounts for biosimilars range from 15-25% relative to originator prices.
Economic Impact
- Volume growth driven by aging population and chronic disease management.
- Price competition depresses revenue growth, compensating with increased volume.
- Future margins for manufacturer depend on biosimilar pricing strategies, patent litigations, and market share.
Risks and Opportunities
Risks
- Patent litigation delays.
- Regulatory hurdles in biosimilar approvals.
- Market entry of alternative anticoagulants.
Opportunities
- Developing next-generation biosimilars.
- Expanding indications (e.g., cancer-associated thrombosis).
- Contracting with healthcare systems to secure volume commitments.
Summary
| Aspect |
Details |
| Current Market Size |
$700 million (U.S., 2022) |
| Price Trends |
Downward trajectory driven by biosimilars |
| Expected Price (2025) |
~$115 per vial |
| Biosimilar Penetration |
Increasing, reaching over 50% by mid-2020s |
| Key Growth Drivers |
Aging population, expanded indications, outpatient use |
Key Takeaways
- The market for NDC 00002-2471 is mature with ongoing biosimilar competition.
- Prices have declined over recent years, with a continued downward trend projected.
- Revenue growth will depend on volume increases offsetting price erosion.
- Patent landscapes and biosimilar development significantly influence future market dynamics.
- Strategic positioning hinges on biosimilar adoption, pricing strategies, and potential label expansions.
FAQs
Q1: How does biosimilar entry affect enoxaparin prices?
A: Biosimilar approval typically results in a 15-25% price reduction, developing increased market share over original products.
Q2: What is the potential impact of new anticoagulants?
A: Alternatives like direct oral anticoagulants could limit the growth of injectable enoxaparin, affecting market size.
Q3: How do hospital procurement policies influence pricing?
A: Hospitals often negotiate discounts to reduce costs, leading to lower effective prices for institutional use.
Q4: What are the main indications for enoxaparin?
A: Prevention and treatment of deep vein thrombosis, pulmonary embolism, and prophylaxis in surgical patients.
Q5: When are significant patent expirations expected?
A: The original enoxaparin patent expired around 2015; biosimilar patents will influence future market entry timelines.
References
[1] IQVIA. (2022). U.S. prescription drug market data.
[2] FDA. (2020). Biosimilar Approvals and Market Entry.
[3] Sanofi. (2022). Enoxaparin (Lovenox) Product Data.
[4] EvaluatePharma. (2022). Market Forecasting for Biologic Drugs.
