ENOXAPARIN SODIUM (PRESERVATIVE FREE) Drug Patent Profile

Which patents cover Enoxaparin Sodium (preservative Free), and what generic alternatives are available?

Enoxaparin Sodium (preservative Free) is a drug marketed by Amphastar Pharm, Be Pharms, Gland, Nanjing King-friend, Sandoz, Shenzhen Techdow, and Zydus Pharms. and is included in seven NDAs.

The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Enoxaparin Sodium (preservative Free)

A generic version of ENOXAPARIN SODIUM (PRESERVATIVE FREE) was approved as enoxaparin sodium by SANDOZ INC on November 28^th, 2011.

Summary for ENOXAPARIN SODIUM (PRESERVATIVE FREE)

US Patents:	0
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	25
DailyMed Link:	ENOXAPARIN SODIUM (PRESERVATIVE FREE) at DailyMed

Pharmacology for ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Drug Class

Low Molecular Weight Heparin

US Patents and Regulatory Information for ENOXAPARIN SODIUM (PRESERVATIVE FREE)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shenzhen Techdow	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	205660-006	Mar 15, 2023	AP	RX	No	No
Sandoz	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	077857-005	Jul 23, 2010	AP	RX	No	No
Zydus Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076726-007	Jun 23, 2014	AP	RX	No	No
Zydus Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076726-003	Jun 23, 2014	AP	RX	No	No
Nanjing King-friend	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	206834-007	Nov 29, 2019	AP	RX	No	No
Sandoz	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	077857-001	Jul 23, 2010	AP	RX	No	No
Sandoz	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	077857-002	Jul 23, 2010	AP	RX	No	No

EU/EMA Drug Approvals for ENOXAPARIN SODIUM (PRESERVATIVE FREE)

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 (PRESERVATIVE FREE) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Enoxaparin Sodium (Preservative Free)

Market Overview

Enoxaparin sodium, a low molecular weight heparin, is a crucial anticoagulant used to prevent and treat various thrombotic disorders. The global market for enoxaparin sodium is experiencing significant growth, driven by increasing demand for preventive healthcare measures and the expanding geriatric population.

Market Size and Growth

The global enoxaparin sodium market was valued at approximately $3,315 million in 2023 and is projected to reach $5,415 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.1% during the forecast period from 2024 to 2030[1].

Another report indicates that the global enoxaparin sodium injection market will be valued at $4,415.2 million in 2024 and is expected to grow at a CAGR of 11.50% from 2024 to 2031, reaching $9,459.6 million by 2031[4].

Regional Market Analysis

Europe

Europe is the largest market for enoxaparin sodium, accounting for nearly 60% of the global market share. This region's dominance is due to the high prevalence of cardiovascular diseases and the well-established healthcare infrastructure[1].

North America

North America holds a significant share of the global market, with the United States being a major contributor. The region's market size was estimated at $1,766.08 million in 2024 and is expected to grow at a CAGR of 9.7% from 2024 to 2031[4].

Asia Pacific

The Asia Pacific region is also witnessing substantial growth, driven by increasing healthcare expenditure and a growing awareness of preventive healthcare measures. This region's market size was estimated at $1,015.50 million in 2024 and is expected to grow at a CAGR of 13.5% from 2024 to 2031[4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa regions, though smaller, are also experiencing growth. Latin America held a market share of around 5% with a market size of $220.76 million in 2024, growing at a CAGR of 10.9%. The Middle East and Africa held around 2% of the global revenue with a market size of $88.30 million in 2024, growing at a CAGR of 11.2% from 2024 to 2031[4].

Market Segmentation

By Product Type

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

By Sales Channel

The market is also segmented by sales channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are the primary distribution channel due to the drug's prescription nature and the need for medical supervision.

Key Players

The global enoxaparin sodium market is highly competitive, with several key players dominating the market. Sanofi is the largest manufacturer, 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, and several others[1].

Financial Performance

Revenue Growth

The financial performance of companies in the enoxaparin sodium market is robust, with many experiencing significant revenue growth. For instance, Sanofi's revenue from Clexane (their brand of enoxaparin sodium) has shown consistent growth, supported by accelerated revenue growth outpacing cost expansion[2].

Profitability

Companies like SPIMACO have reported improved profitability, with net profit increasing by 85% in the first quarter of 2023 compared to the same period in 2022. This improvement is attributed to a gradual increase in gross margin and cost optimization[2].

Market Share

The top three manufacturers in the enoxaparin sodium market account for approximately 66% of the global share, indicating a concentrated market with significant competition among the leading players[1].

Market Drivers

Increasing Demand for Preventive Healthcare

The growing awareness of preventive healthcare measures is a major driver for the enoxaparin sodium market. As more people seek to prevent thrombotic disorders, the demand for anticoagulants like enoxaparin sodium increases[4].

Expanding Geriatric Population

The global geriatric population is increasing, and this demographic is more prone to cardiovascular diseases. This trend is expected to drive the demand for enoxaparin sodium in the coming years[4].

Advances in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in emerging markets, are facilitating better access to anticoagulant therapies, further boosting the market[4].

Market Restraints

Regulatory Challenges

Stringent regulatory requirements and the need for rigorous clinical trials can act as restraints for new entrants in the market. Existing players must also comply with evolving regulatory standards, which can be costly and time-consuming[5].

Competition

The market is highly competitive, with several established players. This competition can make it challenging for new companies to gain significant market share[1].

Cost and Accessibility

The high cost of enoxaparin sodium and issues related to accessibility in some regions can limit market growth. Efforts to reduce costs and improve distribution channels are essential to overcome these challenges[5].

Market Trends

Generic and Biosimilar Entries

The entry of generic and biosimilar versions of enoxaparin sodium is expected to increase competition and potentially reduce prices, making the drug more accessible to a broader population[5].

Technological Advancements

Advancements in drug delivery systems and the development of more efficient manufacturing processes are trends that could enhance the market dynamics of enoxaparin sodium[5].

Strategic Collaborations

Companies are engaging in strategic collaborations and mergers and acquisitions to expand their product portfolios and strengthen their market positions. This trend is likely to continue, driving market growth and innovation[2].

Key Takeaways

• The global enoxaparin sodium market is projected to grow significantly, driven by increasing demand for preventive healthcare and an expanding geriatric population.
• Europe is the largest market, followed by North America and the Asia Pacific.
• Sanofi is the leading manufacturer, holding a substantial market share.
• The market is highly competitive, with several key players.
• Regulatory challenges, competition, and cost issues are significant restraints.
• Generic and biosimilar entries, technological advancements, and strategic collaborations are key trends shaping the market.

FAQs

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

The global enoxaparin sodium market is expected to reach $5,415 million by 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 is the CAGR of the global enoxaparin sodium injection market from 2024 to 2031?

The global enoxaparin sodium injection market is expected to grow at a CAGR of 11.50% from 2024 to 2031[4].

Who is the leading manufacturer of enoxaparin sodium?

Sanofi is the leading manufacturer, holding approximately 42% of the global market share[1].

What are the main drivers of the enoxaparin sodium market?

The main drivers include increasing demand for preventive healthcare, an expanding geriatric population, and advances in healthcare infrastructure[4].

Sources

1. Global Enoxaparin Sodium Market Research Report 2024 - Valuates Reports
2. Earnings Presentation - Spimaco - SPIMACO
3. Enoxaparin Sodium Market Report 2024 (Global Edition) - Cognitive Market Research
4. Enoxaparin Sodium Injection Market Report 2024 (Global Edition) - Cognitive Market Research
5. Global Enoxaparin Sodium Injection Market Size, Trends and ... - Market Research Intellect