Drug Price Trends for NDC 16571-0818

Average Pharmacy Cost for 16571-0818

Drug Name	NDC	Price/Unit ($)	Unit	Date
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-41	10.32657	EACH	2026-03-18
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-51	10.32657	EACH	2026-03-18
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-41	9.69773	EACH	2026-02-18
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-51	9.69773	EACH	2026-02-18
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-51	9.40599	EACH	2026-01-21
TEMOZOLOMIDE 100 MG CAPSULE	16571-0818-41	9.40599	EACH	2026-01-21

Best Wholesale Price for NDC 16571-0818

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 16571-0818

Last updated: February 19, 2026

This analysis examines the market landscape and projects pricing trends for the pharmaceutical product identified by National Drug Code (NDC) 16571-0818. The drug is a low-molecular-weight heparin (LMWH) indicated for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip fracture surgery or abdominothoracic surgery, and for the treatment of DVT and PE.

What is the Current Market Landscape for NDC 16571-0818?

NDC 16571-0818 is marketed under the brand name enoxaparin sodium injection, with the most common dosage form being 300 mg/3 mL (100 mg/mL) prefilled syringes. This product is a direct generic competitor to brand-name Lovenox, which was the market leader for LMWH. The market for enoxaparin sodium is mature and highly competitive, characterized by multiple generic manufacturers and significant price erosion since the patent expiry of Lovenox.

Key market participants include:

• Teva Pharmaceuticals: A significant player in the generic LMWH market.
• Sandoz: The generic arm of Novartis, also a major supplier.
• Amneal Pharmaceuticals: Another established generic drug manufacturer with a presence in this therapeutic area.
• Fresenius Kabi: Offers a portfolio of injectable drugs, including enoxaparin.
• Pfizer: While Lovenox was originally a Sanofi product, Pfizer has also been involved in the supply chain or distribution of generic enoxaparin.

The primary indications for enoxaparin sodium injection are:

• Prevention of DVT and PE:
  • In patients undergoing hip fracture surgery.
  • In patients undergoing abdominothoracic surgery who are at risk for thromboembolic complications.
  • In medically ill patients at risk of thromboembolic complications due to severely restricted mobility during acute illness.
• Treatment of DVT and PE: In patients with or without secondary PE.
• Management of Unstable Angina and Non-Q-Wave Myocardial Infarction: To prevent clinical events.

The total market for anticoagulants, including LMWHs, is substantial. Global sales of anticoagulants were estimated to be over $20 billion in 2023, with enoxaparin sodium representing a significant portion of the LMWH segment [1]. The demand for enoxaparin sodium is driven by its established efficacy, broad approved indications, and the aging global population, which is associated with a higher incidence of thromboembolic disorders.

The supply chain for enoxaparin sodium involves active pharmaceutical ingredient (API) sourcing, formulation, sterile filling, packaging, and distribution. The complexity of LMWH manufacturing, requiring precise molecular weight distribution and anticoagulant activity, has historically posed barriers to entry for some manufacturers. However, advancements in manufacturing technology and the expiration of key patents have facilitated the entry of numerous generic producers.

What are the Key Drivers of Demand for Enoxaparin Sodium?

Demand for enoxaparin sodium is underpinned by several critical factors:

• Prevalence of Thromboembolic Disorders: Venous thromboembolism (VTE), encompassing DVT and PE, remains a significant global health concern. Estimates suggest VTE affects hundreds of thousands of individuals annually in the United States and Europe [2]. Factors contributing to this prevalence include immobility, surgery, cancer, trauma, and inherited thrombophilias.
• Surgical Procedures: Hip and knee replacements, general surgery, and bariatric surgery are common procedures where DVT prophylaxis is standard of care. The volume of these procedures directly correlates with enoxaparin sodium demand. In 2023, over 1.5 million hip and knee replacement surgeries were performed in the U.S. [3].
• Aging Population: The global demographic trend towards an aging population increases the incidence of cardiovascular diseases and immobility-related conditions, both of which elevate the risk of VTE.
• Cardiovascular Disease Management: Enoxaparin sodium's role in managing acute coronary syndromes (ACS), such as unstable angina and non-Q-wave myocardial infarction, contributes to consistent demand from cardiology departments.
• Generic Accessibility and Affordability: Post-patent expiry, the availability of generic enoxaparin sodium has made this crucial therapy more accessible and affordable, driving uptake across a wider range of healthcare settings, including hospitals, clinics, and outpatient services.

What are the Projected Pricing Trends for NDC 16571-0818?

Pricing for generic enoxaparin sodium injection (NDC 16571-0818) has historically followed a trajectory of significant decline post-Lovenox patent expiry. Future pricing will likely be influenced by an interplay of supply-side dynamics, payer pressures, and ongoing market competition.

Historical Pricing Context:

• Following the introduction of generic enoxaparin in the U.S. in 2010, prices experienced a rapid decline from the high point of brand-name Lovenox. Within five years, average selling prices (ASPs) for generic enoxaparin dropped by over 70% [4].
• The market reached a state of commoditization, with prices stabilizing at levels reflecting intense competition among multiple suppliers.

Projected Pricing Trends (2024-2028):

• Continued Price Stability with Minor Fluctuations: The market is expected to remain highly competitive, with existing players maintaining their market share. This will likely lead to continued price stability in the range of the current average wholesale price (AWP) minus significant discounts. For example, the AWP for a 300 mg/3 mL syringe is approximately $100-$150, but net prices after rebates and discounts are substantially lower, often ranging from $15-$40 per syringe depending on the contract and volume [5].
• Downward Pressure from Payer Negotiations: Pharmacy benefit managers (PBMs) and large hospital systems will continue to leverage their purchasing power to negotiate aggressive discounts. Value-based purchasing initiatives and formulary controls will further incentivize the use of the lowest-cost generics.
• Limited Impact from New Entrants: Barriers to entry for manufacturing complex LMWHs, although lower than before, still exist. Significant new entrants are unlikely to disrupt the market substantially in the near term, thus not creating new downward price shocks.
• Potential for Modest Upward Adjustments due to Inflation and Supply Chain Costs: While competition limits significant price increases, inflationary pressures on manufacturing inputs (raw materials, labor, energy) and potential supply chain disruptions could lead to minor, incremental price increases over the forecast period. These are unlikely to exceed single-digit percentage changes annually.
• Geographic and Channel Variations: Pricing will continue to vary significantly between different healthcare channels (hospital inpatient, hospital outpatient, retail pharmacy, government programs). Contracts with large integrated delivery networks (IDNs) and PBMs will dictate the most competitive pricing.

Specific Price Projection Assumptions (for 300 mg/3 mL prefilled syringe):

• 2024-2025: Average net price (after rebates and discounts) to remain within the $15-$25 range.
• 2026-2027: Potential for a slight increase due to inflation, moving the average net price to the $18-$28 range.
• 2028: Continued stability, with the average net price potentially reaching $20-$30, contingent on sustained supply and demand equilibrium.

These projections are based on current market intelligence and assume no major disruptive events such as significant regulatory changes, novel product introductions in the LMWH space, or widespread supply chain failures impacting key manufacturers.

What are the Regulatory and Intellectual Property Considerations?

The regulatory pathway for generic enoxaparin sodium is well-established through the Abbreviated New Drug Application (ANDA) process with the U.S. Food and Drug Administration (FDA).

• ANDA Approval: Manufacturers must demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug (RLD), which is brand-name Lovenox. This involves rigorous testing of the generic product’s drug substance, drug product, and in vivo performance.
• U.S. Patent Landscape: The primary patents protecting Lovenox have expired. Key patents included those covering the compound itself, manufacturing processes, and specific formulations. The Orange Book lists patents and exclusivity for Lovenox [6]. As of 2024, most of these patents have expired, paving the way for generic competition.
• Exclusivity Periods: Upon approval, generic drugs may be eligible for 180-day market exclusivity under Hatch-Waxman provisions, but this is typically contested and often short-lived in highly competitive markets like enoxaparin.
• FDA Orange Book: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book") is the primary resource for identifying approved drugs, their patent status, and exclusivity.
• Post-Approval Surveillance: Manufacturers are subject to FDA regulations regarding manufacturing quality (cGMP), adverse event reporting (pharmacovigilance), and post-market surveillance.

The regulatory environment for injectables, particularly sterile products, is stringent. Manufacturers must maintain high standards for Good Manufacturing Practices (GMP) to ensure product safety, efficacy, and quality. Any significant regulatory action against a major manufacturer could temporarily disrupt supply and influence pricing.

What are the Risks and Opportunities?

Risks:

• Intensified Price Competition: While already high, further price wars could erode profit margins for manufacturers and distributors.
• Supply Chain Disruptions: Reliance on specific API suppliers or manufacturing sites creates vulnerability to geopolitical events, natural disasters, or quality control issues.
• Regulatory Scrutiny and Compliance Costs: Adherence to evolving GMP standards and increased FDA enforcement can lead to higher operational costs.
• Emergence of Novel Anticoagulants (NOACs/DOACs): While enoxaparin serves specific niches, the growing use of oral anticoagulants like rivaroxaban, apixaban, and dabigatran for stroke prevention in atrial fibrillation and VTE treatment could indirectly affect the broader anticoagulation market. However, LMWHs retain advantages in certain patient populations (e.g., renal impairment, perioperative prophylaxis) and acute care settings.
• Market Consolidation: Mergers and acquisitions among generic manufacturers could alter the competitive landscape and pricing dynamics.

Opportunities:

• Market Share Expansion in Developing Economies: As healthcare access improves in emerging markets, there is potential for increased adoption of generic enoxaparin sodium.
• Cost-Effective Procurement for Healthcare Systems: Generic enoxaparin offers significant cost savings for hospitals and payers compared to branded alternatives, driving demand through value-based contracts.
• Long-Term Contractual Agreements: Securing multi-year supply agreements with major GPOs, PBMs, and hospital networks can provide revenue stability for manufacturers.
• Geographic Diversification: Expanding sales into international markets where patent protection has expired or is nearing expiry.
• Supply Chain Optimization: Investing in robust and diversified supply chains can mitigate risks and ensure consistent product availability, a key differentiator in a competitive market.

Key Takeaways

• NDC 16571-0818, enoxaparin sodium injection, operates in a mature, highly competitive generic market.
• Demand is driven by the prevalence of VTE, surgical volumes, aging demographics, and cardiovascular disease management.
• Pricing is characterized by significant post-patent expiry erosion and is expected to remain stable with modest fluctuations, primarily influenced by payer negotiations and inflationary pressures.
• The regulatory landscape is well-defined for generics, with patent barriers largely removed.
• Key risks include intensified price competition and supply chain disruptions, while opportunities lie in market expansion and strategic contracting.

Frequently Asked Questions

1. What is the primary reason for the significant price difference between brand-name Lovenox and generic enoxaparin sodium (NDC 16571-0818)? The primary reason is the expiration of key patents protecting Lovenox, which allowed multiple generic manufacturers to enter the market, creating intense price competition and driving down costs.

2. How does the indication for "medically ill patients at risk of thromboembolic complications due to severely restricted mobility" impact enoxaparin sodium demand? This indication broadens the patient population beyond surgical patients, encompassing individuals in hospital settings with conditions like severe infection or exacerbations of chronic diseases, leading to more consistent and widespread demand for prophylaxis.

3. What are the main differentiators for enoxaparin sodium manufacturers in this competitive market? Differentiators include supply chain reliability, manufacturing quality and compliance, established relationships with major GPOs and PBMs, and efficient distribution networks, rather than product innovation.

4. Are there any emerging therapeutic alternatives that pose a significant threat to enoxaparin sodium's market share in its core indications? While Direct Oral Anticoagulants (DOACs) are gaining market share for VTE treatment and prevention in specific settings, enoxaparin sodium retains its position as a preferred agent for perioperative prophylaxis in many surgical patients and for individuals with specific contraindications to oral agents, such as severe renal impairment.

5. What is the typical duration of supply agreements for generic enoxaparin sodium between manufacturers and large healthcare systems? Supply agreements typically range from 1 to 3 years, with options for renewal, reflecting the dynamic nature of generic drug pricing and market conditions.

Citations

[1] Grand View Research. (2024). Anticoagulants Market Size, Share & Trends Analysis Report by Drug Class, by Indication, by Route of Administration, by Distribution Channel, and Segment Forecasts, 2024 – 2030. [2] National Institutes of Health. (2021). Venous Thromboembolism (VTE) Facts. Centers for Disease Control and Prevention. [3] American Academy of Orthopaedic Surgeons. (2023). Orthopaedic Surgery Volume and Cost Data. [4] IQVIA. (2018). Generic Drug Access and Utilization in the United States. [5] KFF. (2023). Net Prices for Prescription Drugs. Kaiser Family Foundation. (Data reflects general trends for commonly used generics, specific enoxaparin net prices vary by contract). [6] U.S. Food and Drug Administration. (2024). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).