WARFARIN SODIUM - Generic Drug Details

What are the generic drug sources for warfarin sodium and what is the scope of patent protection?

Warfarin sodium is the generic ingredient in five branded drugs marketed by Bristol Myers Squibb, Pharm Res Assoc, Upsher Smith Labs, Abbott, 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 twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for warfarin sodium. Twenty-five suppliers are listed for this compound.

Summary for WARFARIN SODIUM

US Patents:	0
Tradenames:	5
Applicants:	15
NDAs:	21
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	38
Patent Applications:	6,575
Drug Prices:	Drug price trends for WARFARIN SODIUM
Drug Sales Revenues:	Drug sales revenues for WARFARIN SODIUM
What excipients (inactive ingredients) are in WARFARIN SODIUM?	WARFARIN SODIUM excipients list
DailyMed Link:	WARFARIN SODIUM at DailyMed

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See drug sales revenues for WARFARIN SODIUM

Recent Clinical Trials for WARFARIN SODIUM

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

Sponsor	Phase
Amgen	Early Phase 1
Boehringer Ingelheim	N/A
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1

See all WARFARIN SODIUM clinical trials

Pharmacology for WARFARIN SODIUM

Drug Class	Vitamin K Antagonist
Mechanism of Action	Vitamin K Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for WARFARIN SODIUM

B01AA	Vitamin K antagonists
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for WARFARIN SODIUM

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	TABLET;ORAL	009218-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Usl Pharma	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	088719-001	Jun 27, 1985		DISCN	No	No
Pliva	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040616-007	Jul 5, 2006	AB	RX	No	No
Invagen Pharms	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	090935-006	May 25, 2011	AB	RX	No	No
Chartwell Rx	WARFARIN SODIUM	warfarin sodium	TABLET;ORAL	040196-007	Sep 30, 1997		DISCN	No	No

WARFARIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Warfarin Sodium

Introduction to Warfarin Sodium

Warfarin sodium, known by its brand name Coumadin®, is a widely used anticoagulant that prevents blood clots. It has a rich history, dating back to its discovery in the 1930s by University of Wisconsin biochemists who isolated a chemical compound from spoiled hay that prevented blood clotting[2].

Market Size and Forecast

The global Warfarin Sodium (CAS 129-06-6) market is projected to grow significantly over the next few years. As of 2024, the market size was valued at USD 197.69 billion and is expected to reach USD 283.3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.60% from 2024 to 2031[1].

Key Drivers of Market Growth

Increasing Preference for Anticoagulants

The growing demand for anticoagulant therapies, driven by the rising incidence of cardiovascular diseases and clotting disorders, is a major driver of the Warfarin Sodium market. The aging global population, with older adults at higher risk of developing conditions that require anticoagulation therapy, further fuels this demand[4].

Technological Advancements in Drug Formulation

Advancements in drug formulation have improved the solubility, bioavailability, and stability of Warfarin Sodium. Novel formulations, such as Warfarin Sodium Clathrate, offer better control over dosage and more consistent therapeutic effects, reducing the risk of side effects. Extended-release formulations are also being developed to reduce the frequency of administration, improving patient adherence[4].

Generic Versions and Affordability

The introduction of generic versions of Warfarin has made the drug more accessible to a larger portion of the global population. Generic Warfarin Sodium Clathrate is particularly significant in emerging markets where healthcare systems face budget constraints and patients require affordable treatment options[4].

Market Segmentation

By Application

The Warfarin Sodium market is segmented into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies. Hospital pharmacies, which stock a larger variety of medications, including more specialized and investigational medications, are expected to boost demand due to the need for expert advice on drug interactions[1].

By Geography

Geographically, the market is classified into North America, Europe, Asia Pacific, and the Rest of the world. Europe is the fastest-growing market due to high awareness of deep vein thrombosis and pulmonary embolism, while the Asia-Pacific region is expected to grow due to increasing awareness and healthcare investments[1].

Competitive Landscape

The global Warfarin Sodium market is competitive, with key players such as Qilu Pharma, Sine Pharma, Jialin Pharma, Fuda Pharma, Zhongjie Pharma, Amneal Pharma, TEVA, Mylan, and Cipla. These companies are involved in various strategic partnerships and licensing agreements to enhance their market presence. For example, in 2021, Arbutus and Qilu Pharmaceutical entered into an exclusive licensing agreement and strategic partnership[1].

Financial Performance and Key Developments

The financial performance of key players is closely tied to the overall market growth. Companies like Qilu Pharma have secured multiple patents and licensing agreements, which have contributed significantly to their financial stability. For instance, Qilu ranked top 10 in the Chinese Pharmaceutical Industry for four consecutive times, and Cipla was awarded Company of the Year 2021 by the Business Standard[1].

Challenges and Restraints

Despite the growth drivers, the Warfarin Sodium market faces several challenges. The drug has several side effects, such as red or brown urine, black or bloody stool, severe headache or stomach pain, joint pain, vomiting, and coughing up blood. Overdose can lead to severe bleeding or heavier than normal menstrual bleeding, which restricts market growth. Additionally, the development of novel oral anticoagulants (NOACs) like Pradaxa®, Xarelto®, Eliquis®, and Savaysa® has reduced prescription rates for Warfarin, although it remains widely used due to its cost-effectiveness and established efficacy[1][2].

Cost-Effectiveness and Economic Impact

Warfarin sodium is cost-effective, especially for older patients with nonvalvular atrial fibrillation (NVAF). However, the cost-effectiveness varies based on age and additional stroke risk factors. For 65-year-old patients with NVAF alone, warfarin costs about $370,000 per quality-adjusted life-year saved compared to aspirin therapy[5].

Regulatory Approvals and Healthcare Investments

Regulatory approvals for new formulations of Warfarin Sodium Clathrate have contributed to the market's growth. Approvals from agencies like the U.S. FDA and the European Medicines Agency (EMA) have increased the availability of these formulations globally. Additionally, investments in healthcare infrastructure, particularly in emerging markets like India, China, and Latin America, have expanded access to essential treatments, including anticoagulants[4].

Future Outlook

The Warfarin Sodium market is expected to continue growing due to the increasing demand for anticoagulants, technological innovations in drug formulations, and the rising geriatric population. The market will also benefit from increased healthcare investments in emerging economies and the rising demand for affordable generics. Strategic partnerships and licensing agreements among pharmaceutical companies will further drive market growth[4].

Key Takeaways

• The global Warfarin Sodium market is projected to reach USD 283.3 billion by 2031, growing at a CAGR of 4.60% from 2024 to 2031.
• Technological advancements in drug formulation and the availability of generic versions are key growth drivers.
• The market is segmented by application and geography, with Europe being the fastest-growing region.
• Key players are involved in strategic partnerships and licensing agreements to enhance their market presence.
• Despite challenges like side effects and competition from NOACs, Warfarin Sodium remains a widely used and cost-effective anticoagulant.

FAQs

What is the projected market size of Warfarin Sodium by 2031?

The global Warfarin Sodium market is projected to reach USD 283.3 billion by 2031[1].

What are the main drivers of the Warfarin Sodium market?

The main drivers include increasing demand for anticoagulants, technological advancements in drug formulation, and the rising geriatric population[4].

Which regions are expected to see significant growth in the Warfarin Sodium market?

Europe is the fastest-growing market, while the Asia-Pacific region is also expected to grow significantly due to increasing awareness and healthcare investments[1].

What are the side effects of Warfarin Sodium?

Side effects include red or brown urine, black or bloody stool, severe headache or stomach pain, joint pain, vomiting, and coughing up blood. Overdose can lead to severe bleeding or heavier than normal menstrual bleeding[1].

How does Warfarin Sodium compare to newer anticoagulants?

Warfarin Sodium remains a widely used and cost-effective solution, although newer anticoagulants like Pradaxa®, Xarelto®, Eliquis®, and Savaysa® offer fewer dietary restrictions and less invasive medical testing but are more expensive[2].

Cited Sources:

1. Verified Market Research. Warfarin Sodium (CAS 129-06-6) Market Size, Forecast.
2. American Chemical Society. The Invention of Warfarin.
3. Stats and Data. Global Warfarin Sodium Market Investment Landscape 2024-2031.
4. Market Research Intellect. Warfarin Sodium Clathrate Market: Key Trends and Growth Drivers in the Pharma Industry.
5. PubMed. Cost-effectiveness of warfarin and aspirin for prophylaxis of stroke in patients with nonvalvular atrial fibrillation.