ENOXAPARIN SODIUM - Generic Drug Details

What are the generic drug sources for enoxaparin sodium and what is the scope of freedom to operate?

Enoxaparin sodium is the generic ingredient in four branded drugs marketed by Amphastar Pharms Inc, Nanjing King-friend, Sandoz Inc, Sanofi Aventis Us, Amphastar Pharm, Be Pharms, Gland, Sandoz, Shenzhen Techdow, and Zydus Pharms, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for enoxaparin sodium. Seventeen suppliers are listed for this compound.

Summary for ENOXAPARIN SODIUM

US Patents:	0
Tradenames:	4
Applicants:	10
NDAs:	11
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	17
Clinical Trials:	48
Drug Prices:	Drug price trends for ENOXAPARIN SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENOXAPARIN SODIUM
What excipients (inactive ingredients) are in ENOXAPARIN SODIUM?	ENOXAPARIN SODIUM excipients list
DailyMed Link:	ENOXAPARIN SODIUM at DailyMed

See drug prices for ENOXAPARIN SODIUM

Recent Clinical Trials for ENOXAPARIN SODIUM

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

Sponsor	Phase
PT Bio Farma	Phase 4
Imperial College London	Phase 4
Loewenstein Hospital	N/A

See all ENOXAPARIN SODIUM clinical trials

Pharmacology for ENOXAPARIN SODIUM

Drug Class

Low Molecular Weight Heparin

Medical Subject Heading (MeSH) Categories for ENOXAPARIN SODIUM

Anticoagulants

Fibrinolytic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ENOXAPARIN SODIUM

B01AB	Heparin group
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for ENOXAPARIN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOVENOX (PRESERVATIVE FREE)	Injection	enoxaparin sodium	100 mg/mL, 3 mL vials	020164	1	2006-12-07

US Patents and Regulatory Information for ENOXAPARIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-004	Jun 6, 2023	AP	RX	No	No
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-003	Jun 6, 2023	AP	RX	No	No
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	AB	RX	Yes	No
Gland	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	078990-003	Sep 28, 2018	AP	RX	No	No
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-002	Jun 6, 2023	AP	RX	No	No
Shenzhen Techdow	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	205660-003	Mar 15, 2023	AP	RX	No	No
Nanjing King-friend	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	206834-001	Nov 29, 2019	AP	RX	No	No

Expired US Patents for ENOXAPARIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-008	Jun 2, 2000
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-006	Jun 2, 2000
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998

EU/EMA Drug Approvals for ENOXAPARIN SODIUM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Techdow Pharma Netherlands B.V.	Inhixa	enoxaparin sodium	EMEA/H/C/004264 Inhixa is indicated for adults for:Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).Blood clot prevention in the extracorporeal circulation during haemodialysis.	Authorised	no	yes	no	2016-09-15
Pharmathen S.A.	Thorinane	enoxaparin sodium	EMEA/H/C/003795 Thorinane is indicated for adults for:, , - Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery., , - Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL)., , - Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism., , - Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA)., , - Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL)., , - Blood clot prevention in the extracorporeal circulation during haemodialysis., , Prevention and treatment of various disorders related to blood clots in adults.,	Withdrawn	no	yes	no	2016-09-14

ENOXAPARIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Enoxaparin Sodium

Market Overview

Enoxaparin sodium, a low-molecular-weight heparin, is a crucial anticoagulant used to prevent and treat thromboembolic disorders. The global market for enoxaparin sodium is experiencing significant growth, driven by several key factors.

Market Size and Growth

The global enoxaparin sodium market was valued at US$ 3315 million in 2023 and is projected to reach US$ 5415 million by 2030, with a Compound Annual Growth Rate (CAGR) of 7.1% during the forecast period of 2024-2030[1].

Another report estimates that the global Enoxaparin Sodium Injection market will be USD 4415.2 million in 2024 and is expected to grow at a CAGR of 11.50% from 2024 to 2031, reaching USD 9459.6 million by 2031[5].

Market Drivers

Increasing Incidence of Thromboembolic Disorders

The rising incidence of thromboembolic disorders, such as deep vein thrombosis (DVT) and pulmonary embolism (PE), driven by an aging population and increasing obesity rates, is a major driver of the market. In the United States alone, approximately 900,000 individuals experience DVT or PE each year, leading to thousands of fatalities[3].

Advancements in Drug Formulations and Delivery Methods

Innovations in drug delivery systems, such as pre-filled syringes and auto-injectors, have improved patient compliance and reduced the burden on healthcare providers. These advancements make treatment more accessible and enhance patient outcomes[3].

Biosimilars and Generic Versions

The introduction of biosimilars as patents for original formulations expire is expected to increase competition and reduce costs. This shift allows healthcare providers to offer more affordable treatment options, expanding access to essential medications[3].

Market Segmentation

By Type

The market is segmented by product type, with 60 mg/0.6mL being the dominant form, accounting for 29% of the market share. Other types include 20 mg/0.2mL, 30 mg/0.3mL, 40 mg/0.4mL, 80 mg/0.8mL, 100 mg/1mL, 120 mg/0.8mL, 150 mg/1mL, and 300mg/3mL[1].

By Region

Europe is the largest market for enoxaparin sodium, accounting for nearly 60% of the global market share. North America also holds a significant share, with the United States being a major contributor. Emerging markets in Asia-Pacific and Latin America are expected to witness substantial growth as healthcare infrastructure improves in these regions[1][5].

Key Players and Market Share

Sanofi is the world's largest manufacturer of enoxaparin sodium, holding approximately 42% of the global market share. Other significant players include Techdow (Hepalink), Teva, Nanjing King-friend, Rovi, Fresenius Kabi, Fosun Pharma (Gland Pharma), Amphastar, Sandoz (Novartis), Apotex, Huadong Medicine, Cipla, Taj Pharma, Chengdu Baiyu Pharmaceutical, Changzhou Qianhong Bio-pharma, and Beijing SL Pharmaceutical. The top three manufacturers account for approximately 66% of the global share[1].

Financial Performance and Cost-Effectiveness

Revenue and Profitability

The financial performance of companies in the enoxaparin sodium market is robust, with significant revenue growth. For example, Sanofi's Clexane (enoxaparin sodium) has seen accelerated revenue growth, outpacing costs expansion, leading to improved profitability metrics such as gross profit margin and EBIT margin[2].

Cost-Effectiveness

Enoxaparin sodium is more costly than low-dose warfarin but offers favorable cost-effectiveness in preventing deep-vein thrombosis and pulmonary embolism. The cost-effectiveness of enoxaparin relative to low-dose warfarin is estimated to be approximately $12,000 per death averted[4].

Investment and Growth Opportunities

The enoxaparin sodium market is attracting considerable interest from investors due to its growth potential. Companies engaged in research and development, particularly those exploring biosimilars and innovative delivery methods, are well-positioned to capitalize on this expanding market. Emerging markets represent a unique opportunity for growth as healthcare needs and the prevalence of thromboembolic disorders increase in regions such as Asia-Pacific and Latin America[3].

Challenges and Trends

Competition from Biosimilars

The introduction of biosimilars is expected to increase competition and reduce costs, which could impact the market share of original manufacturers. However, this also presents opportunities for companies to offer more affordable treatment options[3].

Regulatory Environment

Navigating the regulatory environment is crucial for companies in the enoxaparin sodium market. Compliance with regulatory standards and approvals is essential for market entry and expansion.

Collaborations and Partnerships

Collaborations between pharmaceutical companies, research institutions, and healthcare providers are becoming increasingly common. These partnerships focus on clinical trials, research, and the development of new formulations, accelerating innovation and improving patient care[3].

Regional Analysis

Europe

Europe is the largest market for enoxaparin sodium, driven by a well-established healthcare system and high demand for anticoagulant therapies. The Rest of Europe is projected to witness growth at a CAGR of 8.7% during the forecast period[5].

North America

North America holds a significant share of the global market, with the United States being a major contributor. The region is expected to grow at a CAGR of 9.7% from 2024 to 2031[5].

Emerging Markets

Emerging markets in Asia-Pacific and Latin America are expected to see substantial growth as healthcare infrastructure improves and the demand for anticoagulant therapies increases.

Key Takeaways

• The global enoxaparin sodium market is projected to grow significantly, driven by the increasing incidence of thromboembolic disorders and advancements in drug formulations.
• Europe is the largest market, but emerging markets in Asia-Pacific and Latin America offer substantial growth opportunities.
• Sanofi is the leading manufacturer, but the market is becoming more competitive with the introduction of biosimilars.
• The cost-effectiveness of enoxaparin sodium is favorable despite being more expensive than low-dose warfarin.
• Collaborations and partnerships are key drivers of innovation and market growth.

FAQs

What is the projected market size of the global enoxaparin sodium market by 2030?

The global enoxaparin sodium market is anticipated to reach US$ 5415 million by 2030[1].

What is the CAGR of the global enoxaparin sodium market from 2024 to 2030?

The global enoxaparin sodium market is expected to witness a CAGR of 7.1% during the forecast period of 2024-2030[1].

Which region holds the largest market share for enoxaparin sodium?

Europe holds the largest market share, accounting for nearly 60% of the global market[1].

What are the main drivers of the enoxaparin sodium market?

The main drivers include the increasing incidence of thromboembolic disorders, advancements in drug formulations and delivery methods, and the introduction of biosimilars[3].

Who is the leading manufacturer of enoxaparin sodium?

Sanofi is the world's largest manufacturer of enoxaparin sodium, holding approximately 42% of the global market share[1].

Cited Sources

1. Global Enoxaparin Sodium Market Research Report 2024 - Valuates Reports
2. Earnings Presentation - Spimaco - SPIMACO
3. A Closer Look at the Enoxaparin Sodium Market Trends, Opportunities, and Challenges - Market Research Intellect
4. Cost-effectiveness of enoxaparin vs low-dose warfarin in preventing deep-vein thrombosis after total hip replacement surgery - PubMed
5. Enoxaparin Sodium Injection Market Report 2024 (Global Edition) - Cognitive Market Research