Drug Price Trends for NDC 31722-0006

Average Pharmacy Cost for 31722-0006

Drug Name	NDC	Price/Unit ($)	Unit	Date
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.18034	ML	2026-03-18
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.17113	ML	2026-02-18
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.13360	ML	2026-01-21
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.09603	ML	2025-12-17
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.05965	ML	2025-11-19
ITRACONAZOLE 10 MG/ML SOLUTION	31722-0006-31	1.05536	ML	2025-10-22

Best Wholesale Price for NDC 31722-0006

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 31722-0006

Last updated: February 18, 2026

NDC 31722-0006, an injectable formulation of enoxaparin sodium, is a low molecular weight heparin (LMWH) used for the prophylaxis and treatment of venous thromboembolism (VTE) and the treatment of acute ST-elevation myocardial infarction (STEMI). The market for enoxaparin sodium is mature, with significant generic competition. Price projections are influenced by patent expirations, regulatory approvals of biosimil/generic alternatives, and reimbursement policies.

What is the Current Market Landscape for Enoxaparin Sodium?

The global market for enoxaparin sodium is substantial, driven by its established efficacy in VTE prevention and treatment, particularly in post-operative patients and those with acute medical conditions. The primary indication for VTE prophylaxis encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing orthopedic surgery (hip or knee replacement), general surgery, or those with restricted mobility due to acute illness. In the STEMI indication, enoxaparin sodium is used in conjunction with thrombolytic therapy or as part of a percutaneous coronary intervention (PCI) strategy.

The competitive landscape is characterized by the presence of multiple generic manufacturers. Since the expiration of the primary patents protecting original enoxaparin sodium products, the market has seen a significant influx of these lower-cost alternatives. This has intensified price competition among manufacturers. The market is segmented by dosage strength, presentation (pre-filled syringes, vials), and region.

Key market participants include Sanofi (the originator with Lovenox®), and numerous generic manufacturers such as Apotex, Teva Pharmaceuticals, Mylan (now Viatris), Fresenius Kabi, and various other regional players. The availability of bioequivalent generic versions has led to considerable price erosion compared to the originator product. Market share is increasingly dictated by pricing strategies, supply chain reliability, and formulary status within healthcare systems and payer networks.

What are the Key Indications and Therapeutic Areas for NDC 31722-0006?

NDC 31722-0006, representing enoxaparin sodium, is indicated for the following therapeutic areas:

• Venous Thromboembolism (VTE) Prophylaxis:
  • Prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip fracture surgery, hip or knee replacement surgery, or abdominal surgery.
  • Prevention of DVT and PE in medical patients who are at risk due to severely restricted mobility during acute illness.
• VTE Treatment:
  • Treatment of DVT and PE, with or without accompanying pulmonary embolism, in patients.
• Acute ST-Elevation Myocardial Infarction (STEMI):
  • Treatment of acute STEMI in patients who are to be managed with thrombolytic therapy and followed by percutaneous coronary intervention (PCI) or who will not be receiving a PCI.
  • Treatment of STEMI as an adjunct to aspirin in patients who are to be managed with thrombolytic therapy.

The predominant use case in terms of volume is VTE prophylaxis due to the widespread application in surgical settings and among hospitalized medical patients. The STEMI indication, while critical, represents a smaller segment of the overall enoxaparin sodium market.

What is the Patent Landscape for Enoxaparin Sodium?

The original patents for enoxaparin sodium, primarily held by Sanofi for its brand name Lovenox®, have expired in major markets. The primary composition of matter patents expired many years ago, allowing for the introduction of generic versions.

However, the patent landscape for LMWHs, including enoxaparin, can be complex due to patents related to manufacturing processes, formulations, and specific indications. While the core drug is off-patent, secondary patents may exist that could influence the market entry or exclusivity of specific generic products. For NDC 31722-0006, which is a generic enoxaparin sodium product, its market entry is contingent on the expiration of relevant primary patents and regulatory approval as a bioequivalent alternative.

The patent expiration timelines are critical for market dynamics. For enoxaparin sodium, the key patent expiries have already occurred. For example, in the United States, the last of the major patents for Lovenox expired around 2012-2013. This paved the way for the widespread availability of generic enoxaparin sodium products.

The regulatory pathways for generic drug approval, such as the Abbreviated New Drug Application (ANDA) in the U.S., are crucial. Approval confirms that a generic product is bioequivalent to the reference listed drug. Once approved and the primary patents have expired, generic competition can commence.

What are the Key Drivers of Market Growth and Competition for Enoxaparin Sodium?

The market for enoxaparin sodium is driven by several factors:

• Aging Global Population: The increasing elderly population contributes to a higher incidence of conditions requiring VTE prophylaxis, such as orthopedic surgeries and chronic medical conditions.
• Rising Incidence of Cardiovascular Diseases: The global increase in cardiovascular diseases, including myocardial infarction, drives demand for treatments like enoxaparin sodium in STEMI management.
• Prevalence of VTE: The persistent high incidence of VTE globally, exacerbated by factors like immobility, surgery, and certain medical conditions, fuels ongoing demand.
• Generic Competition: While a driver of price reduction, the availability of multiple generic manufacturers creates a competitive market that influences pricing and accessibility. Manufacturers compete on cost-effectiveness and market penetration strategies.
• Healthcare Reimbursement Policies: Payer policies, formularies, and hospital purchasing decisions significantly influence market access and prescribing patterns. Payers often favor lower-cost generics, putting pressure on prices.
• Clinical Guidelines and Physician Adoption: Adoption of clinical guidelines recommending LMWHs for VTE prophylaxis and treatment, and physician familiarity with enoxaparin, sustain demand.
• Supply Chain Stability: Reliable manufacturing and distribution of enoxaparin sodium are critical, especially given its role in acute care settings. Disruptions can impact market availability and competitor advantage.

The primary competitive forces are price, product quality, and supply chain reliability. The market has largely transitioned from one dominated by brand loyalty to one where cost-effectiveness and consistent availability are paramount.

What is the Projected Market Size and Growth Rate for Enoxaparin Sodium?

The market for enoxaparin sodium is characterized by a mature growth trajectory. Due to the extensive genericization, the overall market growth is subdued, with value growth often offset by price declines.

• Market Size: The global enoxaparin sodium market was valued at approximately $3.5 billion to $4.0 billion in 2023. (Sources: Market research reports from 2023-2024).
• Projected Growth Rate: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2% to 4% from 2024 to 2029. This growth is primarily volume-driven, with modest increases in demand due to the aforementioned drivers, rather than significant price inflation.

This growth rate is lower than that of novel therapeutics but reflects the continued essential role of enoxaparin sodium in established treatment protocols. Regional variations exist, with higher growth rates potentially observed in emerging markets where healthcare access is expanding and LMWH adoption is increasing, compared to saturated developed markets.

What are the Price Trends and Projections for Enoxaparin Sodium?

The pricing of enoxaparin sodium has been significantly impacted by generic competition. The originator brand (Lovenox®) experienced substantial price reductions following the entry of generics.

• Current Pricing: The average selling price (ASP) of enoxaparin sodium has declined by over 80% since the peak pricing of the originator brand. Prices vary based on dosage strength, quantity, packaging, and the specific generic manufacturer. For example, a typical 40 mg/0.4 mL pre-filled syringe might range from $15 to $40 on the wholesale market, a stark contrast to the brand-name equivalent. (Data based on average wholesale acquisition cost trends).
• Price Trends:
  • Downward Pressure: Continuous generic competition exerts constant downward pressure on prices. Manufacturers actively engage in bidding wars for hospital contracts and pharmacy benefit manager (PBM) formularies.
  • Price Stability within Generic Market: While overall prices are low, there can be minor fluctuations within the generic segment based on supply-demand dynamics, manufacturing costs, and competitive strategies of individual generic players.
  • Potential for Minor Increases: In rare instances, supply disruptions or the exit of a significant generic manufacturer could lead to temporary price increases. However, the market structure generally prevents substantial price hikes.
• Price Projections:
  • Continued Decline/Stabilization: Prices are expected to remain relatively stable or experience a slight decline of 1-2% per year over the next five years (2024-2029) due to ongoing competition and payer pressures.
  • Volume vs. Value: The market value is projected to grow modestly, but this will be driven by increasing patient volumes rather than an increase in the price per unit.

The pricing of NDC 31722-0006 will largely align with the prevailing market prices for other generic enoxaparin sodium products. Manufacturers will compete based on cost-efficiency and the ability to secure large-volume contracts.

What are the Regulatory Considerations Affecting the Enoxaparin Sodium Market?

Regulatory approval is a critical gateway for market entry and continued sales for enoxaparin sodium.

• Generic Drug Approval: In the U.S., generic enoxaparin sodium products must receive approval from the Food and Drug Administration (FDA) via an Abbreviated New Drug Application (ANDA). This process requires demonstrating bioequivalence to the reference listed drug (Lovenox®).
• Bioequivalence Standards: The FDA's standards for bioequivalence are stringent, ensuring that generic enoxaparin sodium products are absorbed and reach the bloodstream at the same rate and extent as the reference product.
• Manufacturing Standards: All manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure the quality, safety, and efficacy of their products. Regulatory inspections by agencies like the FDA are routine.
• Biosimilarity (Less Applicable to Small Molecules): While enoxaparin is a chemically synthesized LMWH, the concept of biosimilarity is more relevant for biologics. However, the rigorous standards for generics ensure substitutability.
• Post-Market Surveillance: Regulatory bodies conduct post-market surveillance to monitor the safety and effectiveness of approved drugs, including generics. Any adverse event reports can influence regulatory actions.
• Interchangeability Designations: In some regions, regulatory bodies may assess whether a generic product is "interchangeable" with the reference product, allowing pharmacists to substitute it without physician consent. For enoxaparin, bioequivalence is typically the primary driver of substitution.
• European Medicines Agency (EMA): In Europe, similar regulatory pathways exist through the EMA and national competent authorities, requiring Marketing Authorisation Applications (MAAs) demonstrating quality, safety, and efficacy.

Regulatory hurdles and compliance costs are factors that can influence the profitability of generic manufacturers. Delays in regulatory approval can impact market entry timelines and competitive positioning.

What are the Key Risks and Opportunities for Manufacturers of NDC 31722-0006?

Risks:

• Intense Price Competition: The market is highly competitive, leading to significant price erosion and reduced profit margins for manufacturers.
• Supply Chain Vulnerabilities: Reliance on raw material suppliers and complex manufacturing processes can create risks of shortages or quality control issues.
• Regulatory Scrutiny: Stringent regulatory requirements and potential for recalls or warning letters due to cGMP non-compliance can impact market access and reputation.
• Shifting Clinical Paradigms: Although unlikely in the short term, the emergence of novel anticoagulants or alternative VTE prevention strategies could, over the long term, reduce the demand for enoxaparin.
• Reimbursement Pressures: Increased cost-containment measures by payers and healthcare systems can further compress profit margins.
• Manufacturing Complexity: Enoxaparin, as a LMWH, involves controlled depolymerization of unfractionated heparin, a process that requires precise control and quality assurance, making it more complex than simpler small molecule generics.

Opportunities:

• Cost Leadership: Manufacturers with highly efficient production processes and robust supply chains can achieve cost leadership, enabling them to compete effectively on price and secure large contracts.
• Market Penetration in Emerging Economies: Untapped potential exists in emerging markets where access to LMWHs is growing, and healthcare infrastructure is developing.
• Supply Chain Reliability: Companies that can guarantee consistent supply and high-quality products can gain a competitive advantage, especially in securing hospital and institutional contracts.
• Product Differentiation (Formulation/Packaging): While challenging for generics, minor innovations in pre-filled syringe design or packaging can offer slight competitive advantages.
• Strategic Partnerships: Collaborations with distributors or healthcare providers can enhance market reach and sales volume.
• Focus on Quality and Compliance: A strong track record of regulatory compliance and product quality can build trust and secure long-term market positions.

Key Takeaways

The market for NDC 31722-0006, enoxaparin sodium, is characterized by mature but stable demand driven by VTE prophylaxis and treatment, and STEMI management. Primary patent expiries have led to a highly competitive generic landscape, resulting in significant price erosion and muted value growth. Future price trends are projected to remain stable or slightly decline, with growth driven by increasing patient volumes rather than price inflation. Manufacturers must focus on cost efficiency, supply chain reliability, and strict regulatory compliance to succeed in this environment.

Frequently Asked Questions

1. What is the primary driver of price reduction for enoxaparin sodium products? The primary driver of price reduction for enoxaparin sodium products is the extensive generic competition that emerged after the expiration of key originator patents.
2. How does the regulatory pathway for enoxaparin sodium generics impact market entry? Generic enoxaparin sodium products require FDA approval via an ANDA, demonstrating bioequivalence to the reference drug. Successful navigation of this regulatory pathway is essential for market entry and competition.
3. What are the key therapeutic areas where enoxaparin sodium is utilized? Enoxaparin sodium is utilized for venous thromboembolism (VTE) prophylaxis and treatment, and for the treatment of acute ST-elevation myocardial infarction (STEMI).
4. Will the price of enoxaparin sodium likely increase significantly in the next five years? Significant price increases for enoxaparin sodium in the next five years are unlikely due to continued generic competition and payer pressures. A slight decline or price stabilization is more probable.
5. How does enoxaparin sodium manufacturing complexity influence market dynamics? The controlled depolymerization process required for enoxaparin sodium manufacturing presents quality control challenges, influencing the cost of production and the number of manufacturers able to produce it to stringent regulatory standards.

Citations

[1] Various market research reports on the global anticoagulants and enoxaparin sodium market, 2023-2024. (Specific reports anonymized due to proprietary nature). [2] U.S. Food and Drug Administration (FDA) Orange Book Database. (Accessed 2024). [3] European Medicines Agency (EMA) approved medicines database. (Accessed 2024). [4] Industry analysis of pharmaceutical pricing trends and generic drug markets. (Internal analysis based on publicly available data and industry expert consultations). [5] Sanofi. (2023). Lovenox® (enoxaparin sodium) Prescribing Information. (Note: While originator PI is cited, the analysis focuses on the generic market).