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Last Updated: December 21, 2024

COUMADIN Drug Patent Profile


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When do Coumadin patents expire, and when can generic versions of Coumadin launch?

Coumadin is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in COUMADIN is warfarin sodium. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Coumadin

A generic version of COUMADIN was approved as warfarin sodium by TARO on July 15th, 1999.

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Summary for COUMADIN
Drug patent expirations by year for COUMADIN
Drug Prices for COUMADIN

See drug prices for COUMADIN

Drug Sales Revenue Trends for COUMADIN

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Recent Clinical Trials for COUMADIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Laval UniversityPhase 2
Helm Vision GroupPhase 1
Mirati Therapeutics Inc.Phase 1

See all COUMADIN clinical trials

US Patents and Regulatory Information for COUMADIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-024 Feb 7, 1995 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-025 Nov 18, 1996 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-022 Mar 1, 1990 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium TABLET;ORAL 009218-023 Aug 24, 1993 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-020 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb COUMADIN warfarin sodium INJECTABLE;INJECTION 009218-012 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

COUMADIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Coumadin (Warfarin)

Introduction to Coumadin (Warfarin)

Coumadin, commonly known as warfarin, is a widely used anticoagulant medication prescribed to prevent and treat blood clots. It has been a staple in cardiovascular care for decades, but its market dynamics and financial trajectory are influenced by several factors.

Market Segmentation

The global warfarin market is segmented based on several criteria:

  • Route of Administration: Warfarin is available in oral and intravenous forms, each catering to different patient needs and medical scenarios[1][3][4].
  • Application: The primary applications include prevention and treatment of conditions such as atrial fibrillation, heart attack, stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE)[1][3][4].

Market Drivers

Several factors drive the growth of the warfarin market:

  • Rise in Prevalence of Cardiovascular Disorders: The increasing incidence of venous thromboembolism (VTE) and other cardiovascular diseases contributes significantly to the demand for warfarin[1][3][4].
  • Growing Geriatric and Obese Population: The elderly and obese populations are more prone to cardiovascular issues, thereby increasing the demand for anticoagulants like warfarin[1].
  • Acceptance of Novel Oral Anticoagulants (NOACs): Although NOACs like Eliquis and Xarelto are gaining traction, warfarin remains a cost-effective and widely accepted alternative, especially in regions with limited access to newer drugs[1][2].

Market Restraints

Despite its widespread use, the warfarin market faces several restraints:

  • Higher Cost of NOACs: The lack of generic competitors for NOACs and their high prices make them less accessible, but they also create a competitive landscape where warfarin is often seen as a more affordable option[2].
  • Lack of Antidotes for NOACs: Unlike warfarin, which has an antidote (vitamin K), NOACs lack specific antidotes, making warfarin a safer choice in some clinical scenarios[1].
  • Frequent Lab Tests: Warfarin requires regular monitoring of International Normalized Ratio (INR) levels, which can be burdensome for patients but also ensures safer use[5].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the warfarin market:

  • Increased Demand: The pandemic led to increased use of anticoagulants, including warfarin, due to the higher risk of blood clots in COVID-19 patients. This surge in demand has contributed to the market's growth[2].
  • Supply Chain Disruptions: However, the pandemic also caused supply chain disruptions, affecting the manufacturing and delivery of warfarin, which temporarily hindered market growth[1].

Financial Trajectory

Market Size and Growth

The global warfarin market is projected to experience significant growth:

  • Current Market Size: The market size was valued at USD 197.69 billion in 2024[4].
  • Projected Growth: It is expected to reach USD 283.3 billion by 2031, growing at a CAGR of 4.60% from 2024 to 2031[4].

Cost Comparison

Warfarin remains a cost-effective option compared to newer anticoagulants:

  • Price: A month's supply of warfarin costs around $10, significantly lower than the $529 and $516 for Eliquis and Xarelto, respectively[2].
  • Medicare Spending: Despite the lower cost, the overall spending on anticoagulants by programs like Medicare Part D is substantial, with warfarin being a more affordable alternative for many patients[2].

Healthcare Costs

The use of warfarin impacts healthcare costs in various ways:

  • Bleeding Events: Warfarin use is associated with a risk of bleeding events, which can increase healthcare costs. However, studies have shown that the healthcare spending for warfarin-sensitive and insensitive individuals does not differ significantly[5].
  • Monitoring Costs: The need for frequent INR monitoring adds to the overall cost but ensures safer use of the medication[5].

Regional Market Dynamics

The warfarin market varies across different regions:

  • North America: This region is a significant market due to the high prevalence of cardiovascular diseases and the presence of major healthcare systems[1][4].
  • Europe: Europe also represents a substantial market, with countries like Germany, the UK, and France contributing to the demand for warfarin[4].
  • Asia-Pacific: The growing healthcare needs in countries like China, Japan, and India are driving the market growth in this region[4].

Competitive Landscape

The warfarin market is characterized by several key players:

  • Qilu Pharma: Known for its pharmaceutical products, including warfarin, Qilu Pharma is a major player in the market[4].
  • Sine Pharma: Another significant player, Sine Pharma, contributes to the global supply of warfarin[4].
  • Jialin Pharma and Fuda Pharma: These companies also play crucial roles in the production and distribution of warfarin[4].

Key Takeaways

  • The warfarin market is driven by the increasing prevalence of cardiovascular disorders and the growing geriatric and obese populations.
  • Despite the rise of NOACs, warfarin remains a cost-effective and widely accepted anticoagulant.
  • The COVID-19 pandemic has increased the demand for warfarin due to its role in preventing blood clots in COVID-19 patients.
  • The market is projected to grow at a CAGR of 4.60% from 2024 to 2031.
  • Regional dynamics vary, with North America, Europe, and Asia-Pacific being significant markets.

FAQs

What is the current market size of the warfarin market?

The current market size of the warfarin market was valued at USD 197.69 billion in 2024[4].

What is the projected growth rate of the warfarin market?

The warfarin market is expected to grow at a CAGR of 4.60% from 2024 to 2031[4].

Why is warfarin preferred over NOACs in some cases?

Warfarin is preferred due to its lower cost, the availability of an antidote (vitamin K), and the need for regular monitoring to ensure safer use[1][2].

How has the COVID-19 pandemic affected the warfarin market?

The pandemic has increased the demand for warfarin due to its use in preventing blood clots in COVID-19 patients, despite causing temporary supply chain disruptions[1][2].

Which regions are significant markets for warfarin?

North America, Europe, and the Asia-Pacific region are significant markets for warfarin due to the high prevalence of cardiovascular diseases and growing healthcare needs[1][4].

Sources

  1. The Insight Partners: Warfarin Market SWOT Analysis by 2031
  2. Healthcare Finance News: Price of two expensive drugs has cost Medicare Part D $46 billion
  3. Market Research Intellect: Warfarin Sales Market Size, Scope And Forecast Report
  4. Verified Market Research: Warfarin Sodium (CAS 129-06-6) Market Size, Forecast
  5. PLOS ONE: Using genomic data to individualize treatment (RIGHT) 10K warfarin

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