Last updated: March 28, 2026
What is NDC 00054-0245?
NDC 00054-0245 is a drug marketed under the proprietary name of Lovenox, with the generic name enoxaparin sodium. It is a low molecular weight heparin (LMWH) indicated for preventing and treating deep vein thrombosis (DVT), pulmonary embolism, and other conditions requiring anticoagulation. Manufactured primarily by Sanofi, Lovenox is widely prescribed in hospital and outpatient settings.
Market Overview
Market Size and Growth
The global enoxaparin market was valued at approximately $7.6 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 6% through 2027, driven by expanding indications and evolving anticoagulant therapies.
Key Drivers
- Expanding Indications: Approval for additional uses such as acute coronary syndromes (ACS) and prophylaxis in cancer-associated thrombosis broadens market potential.
- Growing Cardiovascular Disease Prevalence: An increase in venous thromboembolism (VTE) and arterial clotting cases sustains demand.
- Hospital Use: Routine prophylaxis in orthopedic surgeries and medical conditions sustains consistent consumption.
Competitive Landscape
Major competitors include biosimilar enoxaparin products from companies such as Sandoz and Momenta, which are seeking FDA approval. While biosimilars could reduce prices, current branded sales remain dominant due to prescriber familiarity and patent protections.
Regulatory Status and Patent Landscape
- The original patent for enoxaparin products expired in the U.S. in 2019.
- Congress passed the Biosimilar User Fee Act (BsUFA) in 2012, accelerating biosimilar approvals.
- Sanofi retains exclusivity through formulation patents until 2024, delaying biosimilar market entry.
Pricing Trends
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 10 mg prefilled syringe |
Remarks |
| 2018 |
$250 |
Pre-patent expiry |
| 2020 |
$240 |
Slight decline; brand maintained market dominance |
| 2022 |
$235 |
Biosame trend and increased discounting |
Current Price Range
The typical price for branded enoxaparin (NDC 00054-0245) in the retail sector stands at approximately $230–$250 per 10 mg prefilled syringe. Institutional and hospital discounts can lower consumer prices by 10–20%.
Biosimilar Price Expectations
Biosimilar products are projected to be priced 15–25% lower than the brand, contingent on approval timing and market penetration. Biosimilar entry is forecasted post-2024, aligning with patent expiry.
Price Projections (2023–2027)
| Year |
Estimated Price Range (per 10 mg syringe) |
Key Assumptions |
| 2023 |
$230–$250 |
Post-patent expiration, limited biosimilar presence |
| 2024 |
$215–$235 |
Biosimilar approvals, initial market penetration, patent expiry |
| 2025 |
$200–$220 |
Increased biosimilar competition, market stabilization |
| 2026 |
$190–$210 |
Biosimilars gain market share, price competition intensifies |
| 2027 |
$180–$200 |
Established biosimilar market, steady decline |
Market Challenges
- Biosimilar Competition Delays: Regulatory hurdles and manufacturing complexities slow biosimilar adoption.
- Pricing Pressure: Payer negotiations and formulary inclusion favor lower-cost alternatives.
- Clinical Preference: Clinician familiarity with branded enoxaparin sustains demand despite biosimilar availability.
Opportunities
- Global Expansion: Markets outside the U.S., particularly Europe and Asia, where biosimilar uptake is variable, present growth opportunities.
- New Indications: Adoption for additional uses could expand revenue streams.
- Formulation Innovation: Development of novel delivery forms or combination therapies may command premium pricing.
Risks
- Patent Litigation: Ongoing patent disputes could extend exclusivity.
- Regulatory Delays: Biosimilar approval processes remain unpredictable.
- Market Entry of Generics: Rapid generic penetration could further reduce prices.
Key Takeaways
- The current branded price for enoxaparin (NDC 00054-0245) remains stable, accessible around $230–$250 per syringe.
- Patent expiry in 2024 paves the way for biosimilar competition, expected to lower prices by roughly 15–25% within two years.
- Price decline will depend on biosimilar approval speed, market acceptance, and payer strategies.
- New indications and global markets could offset pricing pressures, creating additional revenue streams.
- Competition, regulatory, and patent risks endure, influencing long-term price and market share projections.
FAQs
-
When will biosimilars for enoxaparin be available in the U.S.?
Biosimilars are expected to receive FDA approval post-2024, following patent expiries.
-
How much could biosimilar enoxaparin reduce prices?
Biosimilars are projected to cost 15–25% less than the brand, translating into roughly $32–$50 savings per 10 mg syringe.
-
What is the main driver for enoxaparin market growth?
Increased use in VTE prophylaxis and treatment, along with expanding indications like ACS, sustain demand.
-
Are there notable regional variations in prices?
Yes. In Europe, prices tend to be lower due to different reimbursement policies; in Asia, growth is driven by expanding healthcare infrastructure.
-
What factors could delay biosimilar market entry?
Patent litigation, regulatory bottlenecks, and manufacturing challenges are primary obstacles.
References
[1] Grand View Research. (2022). Enoxaparin Market Size, Trends & Forecast.
[2] IQVIA. (2022). U.S. Pharmaceutical Pricing and Market Trends.
[3] U.S. Food and Drug Administration. (2022). BLA Approvals and Biosimilar Guidance.
[4] Congressional Research Service. (2021). Biosimilar Competition and Patent Settlements.
