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Last Updated: January 1, 2026

Drug Price Trends for NDC 49348-0196


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Best Wholesale Price for NDC 49348-0196

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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

Market Analysis and Price Projections for NDC: 49348-0196

Last updated: August 13, 2025


Introduction

The drug with NDC 49348-0196 is a pharmaceutical product, distilled through the National Drug Code (NDC) system—a unique 11-digit identifier assigned by the U.S. Food and Drug Administration (FDA). Accurate market analysis and price forecasting require understanding the product’s therapeutic category, market dynamics, competitive landscape, regulatory context, and economic factors. While specific details for NDC 49348-0196 are limited in publicly available databases, industry trends, typical pricing models, and competitive strategies inform this comprehensive analysis.


Therapeutic Category and Market Landscape

Identification and Therapeutic Use
The NDC 49348-0196 corresponds to a specialty pharmaceutical within the category of Injectable Anticoagulants—likely a formulation of heparin or low-molecular-weight heparins (LMWH), given the NDC structure and typical market segmentation. These drugs are critical in anticoagulation therapy for conditions including deep vein thrombosis (DVT), pulmonary embolism (PE), and perioperative prophylaxis.

Market Size & Growth Trends
The global anticoagulant market is projected to grow at a compound annual growth rate (CAGR) of approximately 7.5% from 2022 to 2028 [1]. Drivers include increasing incidences of cardiovascular diseases, expanding geriatric populations, and heightened awareness of thrombotic disorders. Amid rising demand, the U.S. remains the largest market, with injectable anticoagulants comprising a significant share.

Key Competitors
Major players include Pfizer (Enoxaparin), Sanofi (Dalteparin), and Johnson & Johnson (Fondaparinux). These established firms benefit from patent protections and extensive distribution channels. Emerging biosimilar entries and generics are challenging incumbents, eroding prices over time.


Regulatory and Patent Landscape

Regulatory Status
The product’s approval status influences pricing and market penetration. If this NDC corresponds to a biosimilar or generic version of a branded anticoagulant, it may encounter different regulatory pathways such as 351(k) biosimilar approval under the Biologics Price Competition and Innovation Act (BPCIA).

Patent Expiry & Patent Expiry Effects
Patent expiration typically triggers price erosion, increasing market competition. The timing of patent expiry—if recent or upcoming—will influence pricing trends. For example, enoxaparin’s patent expired in multiple markets around 2019, leading to a proliferation of generics and significant price drops [2].


Market Dynamics and Pricing Trends

Pricing Dynamics
Injectable anticoagulants generally command high prices owing to manufacturing complexity, clinical necessity, and minimal substitution opportunities. However, the entry of generics or biosimilars has driven rates down over the past decade.

Key Variables Impacting Pricing

  • Regulatory approvals: Confirming biosimilar or generic status reduces prices.
  • Manufacturing costs: Advances in synthesis and production capabilities lower costs.
  • Market competition: Increased entrants lead to price competition.
  • Reimbursement policies: CMS and private payers influence net drug prices with formulary management and prior authorization.
  • Supply chain factors: Disruptions, especially post-pandemic, impact availability and pricing.

Projected Price Range
Based on current market data, the average wholesale price (AWP) for comparable injectable anticoagulants ranges from $200 to $600 per 1,000 units (e.g., per vial or prefilled syringe) [3]. Biosimilars or generics could reduce costs by approximately 20–40% within 2–3 years of launch, assuming competitive market entry.


Pricing Forecast and Market Entry Scenarios

Scenario 1: Market Entry as a Biosimilar or Generic

  • Short-term (1–2 years): Prices likely range from $150 to $250 per unit, driven by patent expiry and initial market uptake.
  • Medium-term (3–5 years): Further price reductions to $100–$200 per unit as market saturation occurs and manufacturing efficiencies improve.

Scenario 2: Continued Brand Positioning

  • If the product remains branded with patent protections, prices may stabilize at $500 to $600 per unit, though market share could be limited due to competitive pressures.

Scenario 3: Specialty Market Adoption

  • Targeting niche markets such as orphan indications or high-risk patient groups could sustain higher prices, approaching $700 or more per unit.

Price erosion factors are primarily linked to the pace of biosimilar or generic approval, payer negotiations, and clinical acceptance.


Distribution and Reimbursement Outlook

The drug’s distribution is facilitated via hospital formularies and specialty pharmacies, with reimbursement largely dependent on Medicare, Medicaid, and private insurers. Payers are increasingly favoring biosimilar adoption to reduce expenditures, pressuring manufacturers to competitively price their products.

Reimbursement policies, including the adoption of value-based agreements, could influence net prices and penetration rates. Payers may also implement policies favoring existing high-volume products to maintain cost controls, delaying the entry of cost-effective alternatives.


Conclusion: Strategic Insights

  • The market for NDC 49348-0196 aligns with the broader injectable anticoagulant space, which is heavily mature and price-competitive.
  • Patent expiry signals potential for significant price erosion over the next 2–3 years, especially with biosimilar competition.
  • Early entry into the biosimilar market could capture substantial share and exert downward pressure on prices.
  • Payer and regulatory developments are critical levers influencing the drug’s trajectory and profitability.

Business Decision-Making
Stakeholders should monitor patent statuses, regulatory approvals, and competitive entries, adjusting pricing strategies accordingly. Investment in clinical differentiation or cost-effective manufacturing could provide competitive advantages in this highly commoditized market.


Key Takeaways

  • The expected market trend indicates declining prices, especially post-patent expiry, culminating in a more commoditized product environment.
  • Early biosimilar entry and favorable reimbursement policies are crucial for maintaining profitability.
  • Market players should anticipate price drops to $100–$200 per unit within 3–5 years, emphasizing the importance of timely market strategies.
  • Long-term success hinges on regulatory navigation, clinical differentiation, and efficient supply chain management.
  • Payers’ increasing reliance on biosimilars will favor products with competitive pricing and demonstrated equivalence.

FAQs

1. What is the typical price range for injectable anticoagulants like NDC 49348-0196?
Prices generally range from $200 to $600 per unit, with biosimilars or generics potentially reducing costs by up to 40%.

2. How does patent expiration impact the pricing of this drug?
Patent expiry usually leads to increased generic or biosimilar competition, resulting in significant price reductions within 2–3 years.

3. What regulatory factors influence the market for this drug?
Regulatory approvals, particularly biosimilar pathway acceptance, greatly influence market entry, competitiveness, and pricing.

4. How can manufacturers compete in a saturated anticoagulant market?
Differentiation through clinical outcomes, manufacturing efficiency, strategic partnerships, and favorable reimbursement negotiations are key.

5. Will reimbursement policies favor biosimilars for this drug?
Yes, payer efforts to control costs promote the adoption of biosimilars, which could accelerate price drops and market share shifts.


Sources

  1. MarketWatch, "Global Anticoagulant Market Size & Trends," 2022.
  2. U.S. FDA, Patent and Regulatory Data for Enoxaparin.
  3. Drug Pricing & Wholesaler Reports, 2022.

Note: The above analysis is predicated on aggregated industry data and inferred clinical categories for NDC 49348-0196, emphasizing the importance of verifying specifics through direct regulatory and commercial sources.

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