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Last Updated: December 22, 2024

WARFARIN Drug Patent Profile


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When do Warfarin patents expire, and what generic alternatives are available?

Warfarin is a drug marketed by Amneal Pharms, Aurobindo Pharma Usa, Barr, Chartwell Rx, Invagen Pharms, Ipca Labs Ltd, Pliva, Taro, Usl Pharma, Watson Labs, and Zydus Pharms Usa. and is included in seventeen NDAs.

The generic ingredient in WARFARIN 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 Warfarin

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

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

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Drug Sales Revenue Trends for WARFARIN

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US Patents and Regulatory Information for WARFARIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro WARFARIN SODIUM warfarin sodium TABLET;ORAL 040301-001 Jul 15, 1999 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Invagen Pharms WARFARIN SODIUM warfarin sodium TABLET;ORAL 090935-005 May 25, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx WARFARIN SODIUM warfarin sodium TABLET;ORAL 040196-004 Sep 30, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms Usa WARFARIN SODIUM warfarin sodium TABLET;ORAL 040663-006 May 30, 2006 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ipca Labs Ltd WARFARIN SODIUM warfarin sodium TABLET;ORAL 200104-004 Jun 27, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pliva WARFARIN SODIUM warfarin sodium TABLET;ORAL 040616-005 Jul 5, 2006 AB RX 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

WARFARIN Market Analysis and Financial Projection Experimental

Warfarin Market Dynamics and Financial Trajectory

Market Overview

Warfarin, a widely used anticoagulant, has been a staple in the prevention and treatment of blood clots, including conditions such as atrial fibrillation, heart attack, stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). Here’s a detailed look at the market dynamics and financial trajectory of warfarin.

Market Segmentation

The global warfarin market is segmented based on the route of administration and application.

  • Route of Administration: The market is divided into oral warfarin and intravenous warfarin. Oral warfarin is the most common form due to its ease of administration and patient compliance[1].
  • Application: The market is segmented into atrial fibrillation and heart attack, stroke, DVT, PE, and other conditions. These segments highlight the diverse clinical uses of warfarin[1].

Market Drivers

Several factors are driving the growth of the warfarin market:

  • Rise in Prevalence of Venous Thromboembolism (VTE) and Cardiovascular Disorders: The increasing incidence of VTE and cardiovascular diseases is a significant driver, as warfarin is often prescribed to prevent these conditions[1].
  • Growing Obese and Geriatric Population: The rise in the obese and geriatric population increases the demand for anticoagulants like warfarin, as these groups are more prone to blood clotting disorders[1].
  • Acceptance of Novel Oral Anticoagulants (NOACs): Although NOACs are gaining acceptance, warfarin remains a viable option due to its lower cost and established efficacy. Growing awareness of NOACs in developing regions also indirectly supports the warfarin market[1].

Market Restraints

Despite the drivers, there are several restraints affecting the warfarin market:

  • Higher Cost of NOACs and Lack of Antidotes: The higher cost of NOACs and the absence of antidotes for these drugs are significant restraints. However, warfarin’s lower cost and the availability of an antidote (vitamin K) make it a more accessible option for many patients[1].
  • Bleeding Risks and Monitoring Requirements: Warfarin carries a high risk of bleeding and requires frequent lab tests to monitor the international normalized ratio (INR), which can be a deterrent for some patients[3].

Regional Framework

The global warfarin market is analyzed across several regions:

  • North America: This region has a significant market share due to high awareness and prevalence of cardiovascular diseases.
  • Europe: Europe is expected to be the fastest-growing market for warfarin, driven by high awareness of DVT and PE, and the use of warfarin for stroke prevention[2].
  • Asia-Pacific: This region is expected to grow due to increasing awareness and the rising prevalence of cardiovascular diseases.
  • Middle East and Africa (MEA) and South America: These regions also show potential for growth, though at a slower pace compared to other regions[1].

Financial Trajectory

Market Size and Forecast

  • The warfarin market is projected to grow at a CAGR of around 4.60% from 2024 to 2031, with the market size expected to reach USD 283.3 billion by 2031, up from USD 197.69 billion in 2024[2].

Revenue Forecast

  • The market size is forecasted to increase significantly over the next few years, driven by the increasing demand for anticoagulants and the cost-effectiveness of warfarin compared to NOACs[2].

Cost Comparison

  • Warfarin remains significantly cheaper than NOACs like Eliquis and Xarelto, with a monthly cost of around $10 compared to over $500 for the newer drugs. This cost difference makes warfarin an attractive option for many patients and healthcare systems[3].

Distribution Channels

The warfarin market is segmented by distribution channels:

  • Hospital Pharmacies: These pharmacies hold the highest share due to the specialized and often investigational nature of medications prescribed in hospital settings[2].
  • Retail Pharmacies and Online Pharmacies: These channels also contribute to the market, especially for patients who require ongoing anticoagulant therapy[2].

Impact of COVID-19

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

  • Supply Chain Disruptions: The pandemic led to shutdowns and supply chain disruptions, affecting the manufacturing and delivery of warfarin and other medications[1].
  • Increased Demand for Anticoagulants: The pandemic highlighted the importance of anticoagulants in treating COVID-19 patients, potentially increasing demand for warfarin and other blood thinners[3].

Key Players and Competitive Landscape

The warfarin market is competitive, with several key players:

  • Qilu Pharma, Sine Pharma, Jialin Pharma, Fuda Pharma, Zhongjie Pharma, Amneal Pharma, TEVA, Mylan, and Cipla: These companies are major players in the market, with strategies including product launches, partnerships, and acquisitions to expand their market share[2].

Key Developments

Recent key developments include:

  • Exclusive Licensing Agreements: Companies like Qilu Pharmaceutical have entered into strategic partnerships to enhance their market presence[2].
  • Market Rankings and Awards: Companies such as Cipla have been recognized for their performance in the pharmaceutical industry[2].

Challenges and Opportunities

Challenges

  • High Bleeding Risk: Warfarin’s high bleeding risk and the need for frequent monitoring are significant challenges.
  • Generic Competition: The presence of generics can limit the revenue growth of branded warfarin products[4].

Opportunities

  • Growing Awareness in Developing Regions: Increasing awareness of anticoagulants in developing regions presents a significant opportunity for market growth.
  • Cost-Effectiveness: Warfarin’s lower cost compared to NOACs makes it an attractive option for healthcare systems and patients, especially in regions with limited healthcare budgets[2].

Key Takeaways

  • The warfarin market is driven by the increasing prevalence of VTE and cardiovascular disorders.
  • The market is segmented by route of administration and application, with oral warfarin being the most common form.
  • Warfarin remains cost-effective compared to NOACs, making it a preferred option for many patients.
  • The market is expected to grow at a CAGR of around 4.60% from 2024 to 2031.
  • Key players are focusing on strategic partnerships and product launches to expand their market share.

FAQs

1. What is the projected CAGR for the warfarin market from 2024 to 2031?

The warfarin market is projected to grow at a CAGR of around 4.60% from 2024 to 2031[2].

2. What are the main drivers of the warfarin market?

The main drivers include the rise in prevalence of VTE and cardiovascular disorders, the growing obese and geriatric population, and the increasing acceptance of NOACs in developing regions[1].

3. How does the cost of warfarin compare to NOACs like Eliquis and Xarelto?

Warfarin is significantly cheaper, with a monthly cost of around $10, compared to over $500 for Eliquis and Xarelto[3].

4. What is the impact of COVID-19 on the warfarin market?

The pandemic led to supply chain disruptions but also highlighted the importance of anticoagulants in treating COVID-19 patients, potentially increasing demand for warfarin[1][3].

5. Who are the key players in the warfarin market?

Key players include Qilu Pharma, Sine Pharma, Jialin Pharma, Fuda Pharma, Zhongjie Pharma, Amneal Pharma, TEVA, Mylan, and Cipla[2].

Cited Sources

  1. The Insight Partners - Warfarin Market SWOT Analysis by 2031[1]
  2. Verified Market Research - Warfarin Sodium (CAS 129-06-6) Market Size, Forecast[2]
  3. Healthcare Finance News - Price of two expensive drugs has cost Medicare Part D $46 billion[3]
  4. Fortune Business Insights - Anticoagulants Market Size, Share & Growth | Forecast Report, 2032[4]

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