Enoxaparin sodium - Generic Drug Details

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

Enoxaparin sodium is the generic ingredient in four branded drugs marketed by Amphastar Pharms Inc, Emerge Bioscience, 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. Sixteen 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:	16
Clinical Trials:	52
Drug Prices:	Drug price trends 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
Peking University People's Hospital	NA
Chinese Academy of Medical Sciences, Fuwai Hospital	NA
Piotr Czempik	PHASE4

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
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	AP	RX	Yes	Yes
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-002	Jun 6, 2023	AP	RX	No	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998	AP	RX	Yes	No
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-004	Jun 6, 2023	AP	RX	No	No
Emerge Bioscience	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	206834-006	Nov 29, 2019	AP	RX	No	No
Amphastar Pharm	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076684-007	Sep 19, 2011	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	4,486,420
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998	5,389,618
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	4,692,435
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-008	Jun 2, 2000	4,692,435
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-006	Jun 2, 2000	5,389,618
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	4,692,435

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/004264Inhixa 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/003795Thorinane 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

Market Dynamics and Financial Trajectory for Enoxaparin Sodium

Last updated: October 29, 2025

Introduction

Enoxaparin sodium, a low-molecular-weight heparin (LMWH), is a widely prescribed anticoagulant used for the prevention and treatment of thromboembolic disorders. It functions by inhibiting factor Xa, thereby reducing the formation of blood clots. Since its approval in the late 1990s, enoxaparin has established a commanding presence within the global anticoagulant market. This article offers a comprehensive analysis of the current market dynamics and financial trajectory shaping the future of enoxaparin sodium, providing actionable insights for stakeholders across the pharmaceutical landscape.

Market Overview

The enoxaparin sodium market has experienced robust growth over the past two decades, driven by multifactorial influences including expanding clinical applications, rising prevalence of thromboembolic conditions, and technological advancements in drug manufacturing. As per recent market reports, the global LMWH market size was valued at approximately USD 13 billion in 2022, projected to expand at a compound annual growth rate (CAGR) of around 7-8% through 2030 [1].

The major players in this domain comprise Sanofi (Lovenox), Johnson & Johnson (Janssen), and various regional manufacturers. While Sanofi’s branded Lovenox remains dominant, the market has seen considerable expansion of biosimilars and generic enoxaparin products, fostering increased competition and more accessible pricing.

Market Drivers

Growing Incidence of Thromboembolic Disorders

Increasing global prevalence of venous thromboembolism (VTE), deep vein thrombosis (DVT), and pulmonary embolism (PE) significantly bolsters demand for enoxaparin. Aging populations, sedentary lifestyles, obesity, and rising cancer rates underscore this trend. The World Health Organization estimates that the incidence of VTE is approximately 1-2 per 1,000 annually in developed nations, with rates ascending in emerging economies [2].

Expanding Therapeutic Indications

Beyond prophylaxis in surgical and medical hospital settings, enoxaparin’s indications have broadened to include treatment of acute coronary syndromes, unstable angina, and even off-label uses like deep vein thrombosis prophylaxis post-orthopedic surgeries. This diversification sustains robust demand streams.

Advancements in Administration and Formulations

Innovations such as prefilled syringes, low-dose formulations, and indications for outpatient use enhance patient compliance and clinical convenience, fostering market growth. Ease of subcutaneous administration permits broadening of outpatient therapies, reducing hospital expenditure.

Favorable Regulatory Frameworks

Regulatory agencies, notably the FDA and EMA, support the development and registration of biosimilar enoxaparin products, promoting competition and affordability. The approval process for biosimilars has become more streamlined, increasing market penetration [3].

Healthcare Infrastructure Expansion in Emerging Economies

Rising healthcare investments in emerging markets like China, India, and Brazil facilitate increased access to advanced anticoagulant therapies, translating to geographic growth opportunities for enoxaparin producers.

Market Challenges

Generic Competition and Biosimilars

The entry of biosimilar enoxaparin products has inserted pricing pressures into the market. While biosimilars extend treatment affordability, they also threaten the revenue streams of branded formulations, notably Lovenox. The legal landscape regarding biosimilar approval varies across jurisdictions, affecting market dynamics.

Safety and Regulatory Concerns

Increased scrutiny on safety, notably the risk of heparin-induced thrombocytopenia (HIT), demands vigilant post-market surveillance. Regulatory agencies may impose stringent adverse event reporting requirements, potentially constraining market expansion.

Manufacturing Complexity

Enoxaparin's manufacturing involves intricate processes like controlled depolymerization, which complicates biosimilar development. Ensuring batch-to-batch consistency remains critical, with high entry barriers for new entrants.

Cost Pressure and Price Erosion

Heightened competition, especially from biosimilars, is exerting downward pressure on prices. Payers and government health programs are increasingly negotiating for reduced reimbursement rates, affecting profit margins.

Financial Trajectory and Future Outlook

Revenue Projections

Forecasts estimate the enoxaparin sodium market will grow from approximately USD 13 billion in 2022 to over USD 24 billion by 2030, with regional variations influencing growth rates. The Asia-Pacific region is anticipated to witness the fastest expansion, driven by healthcare infrastructure development and increased disease awareness [1].

Impact of Biosimilars on Revenue Streams

Biosimilars, projected to capture 25-35% of the market by 2030, are expected to significantly impact revenue distributions. Sanofi’s Lovenox and other pioneer brands will face revenue erosion as biosimilars mature. Patent expirations, notably in the late 2020s, will accelerate this trend.

Pricing and Reimbursement Trends

Payers are pushing for lower drug prices through negotiations and formulary management. Governments are incentivizing outpatient and home-based administrations, which could reshape revenue streams by reducing hospital-related sales.

R&D and Innovation Directions

Investment in next-generation LMWHs, with enhanced safety profiles, reduced adverse events, and customizable dosing, could revitalize growth. Alternatively, development of oral anticoagulants may pose competitive threats, necessitating strategic adaptations.

Strategic Market Opportunities

Emerging markets offer substantial growth potential, especially where infrastructure upgrades and increasing disease burden drive demand. Partnership models, licensing agreements, and localized manufacturing are key strategies to capitalize on these opportunities.

Regulatory and Market Outlook

The evolving regulatory landscape favors biosimilar approvals, streamlining access in multiple jurisdictions. Policymakers aim to balance drug safety, affordability, and innovation, with some countries incentivizing biosimilar adoption through preferential reimbursement schemes.

In the immediate future, the monopolistic advantage of branded enoxaparin will diminish, prompting incumbents to invest in next-generation therapies or diversify their portfolios. Investment in digital health monitoring, personalized dosing, and bioengineering could influence market leadership trajectories.

Conclusion

The enoxaparin sodium market positions itself at a pivotal juncture characterized by sustained growth amidst intensifying competition. Fortified by expanding indications, technological advancements, and emerging market demand, the financial trajectory predicts considerable expansion into the next decade. However, declining prices driven by biosimilar entries and regulatory scrutiny underscore the necessity for innovation, strategic differentiation, and geographic diversification.

Stakeholders who proactively navigate these complexities—through embracing biosimilar opportunities, investing in R&D, and expanding in emerging markets—will be best positioned for sustained financial performance. Adaptive strategies aligned with evolving healthcare policies and patient needs will determine enduring success in this dynamic landscape.

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Key Takeaways

• The global enoxaparin sodium market is projected to grow at a CAGR of approximately 7-8% through 2030, reaching upwards of USD 24 billion.
• Increasing thromboembolic disease burden and expanding therapeutic indications underpin market demand.
• Competition from biosimilars is intensifying, leading to price erosion but also creating opportunities for cost-effective alternatives.
• Regulatory trends favor biosimilar approvals, especially in emerging markets, offering pathways for rapid expansion.
• Innovation in formulations, safety, and delivery mechanisms remains critical to maintaining competitive advantage.
• Geographic diversification, particularly in emerging economies, may offset mature market pressures.

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FAQs

1. How does biosimilar competition influence enoxaparin market profitability?
Biosimilars typically reduce costs and wholesale prices, increasing market accessibility but concurrently diminishing profit margins for branded drugs like Lovenox. Strategic differentiation and portfolio diversification are vital for maintaining profitability.

2. What are the primary therapeutic indications for enoxaparin?
Enoxaparin is primarily used for prophylaxis and treatment of deep vein thrombosis, pulmonary embolism, and acute coronary syndromes, including unstable angina and non-ST elevation myocardial infarction.

3. Are there safety concerns associated with enoxaparin?
Yes. The risk of heparin-induced thrombocytopenia (HIT) and bleeding complications necessitate careful patient monitoring. Regulatory agencies require robust post-marketing surveillance to ensure safety.

4. Which regions are expected to drive enoxaparin market growth?
North America and Europe remain mature markets, but Asia-Pacific is anticipated to experience rapid growth owing to expanding healthcare infrastructure and increasing disease prevalence.

5. What future innovations could impact enoxaparin's market?
Developments include oral anticoagulants supplanting injectable LMWHs, next-generation LMWHs with improved safety, and biosimilars that enhance access and affordability.

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References

[1] MarketWatch, "Global Low Molecular Weight Heparin Market Size," 2022.
[2] World Health Organization, "Thromboembolic Disease Epidemiology," 2021.
[3] FDA, "Biosimilar Approval Guidelines," 2020.