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
Chinese Academy of Medical Sciences, Fuwai Hospital	NA
Peking University People's 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
Amphastar Pharm	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076684-002	Sep 19, 2011	AP	RX	No	No
Sandoz	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	077857-003	Jul 23, 2010	AP	RX	No	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998	AP	RX	Yes	No
Shenzhen Techdow	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	205660-004	Mar 15, 2023	AP	RX	No	No
Be Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	214646-004	Jun 6, 2023	AP	RX	No	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998	AP	RX	Yes	No
Sandoz	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	077857-004	Jul 23, 2010	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	020164-008	Jun 2, 2000	5,389,618
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	RE38743
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-001	Mar 29, 1993	RE38743
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	5,389,618
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-007	Jun 2, 2000	5,389,618
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	4,486,420
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	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: December 27, 2025

Executive Summary

Enoxaparin sodium, a low molecular weight heparin (LMWH), is widely used for thromboprophylaxis and treatment of thromboembolic disorders. The drug's market is experiencing significant growth driven by an aging global population, rising incidences of cardiovascular diseases, and expanding applications in surgical procedures. This report examines enoxaparin sodium's market drivers, competitive landscape, regulatory environment, and financial trajectory, offering strategic insights into its future outlook.

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What Are the Key Market Drivers for Enoxaparin Sodium?

Global Burden of Cardiovascular and Thromboembolic Diseases

Disease Type	Prevalence (2022, global estimates)	Key Trends
Deep Vein Thrombosis (DVT)	~7 million annually globally [1]	Rising in aging populations
Pulmonary Embolism (PE)	Approximately 1 in 1,000 annually [2]	Increased diagnosis with advanced imaging
Atrial Fibrillation (AF)	37.5 million globally [3]	Growing due to lifestyle factors
Postoperative Thrombosis	Significant in orthopedic and cancer surgeries	Expansion of surgical prophylaxis

Expansion of Clinical Indications and Off-Label Usage

• Use in acute coronary syndrome (ACS), unstable angina, and non-ST-elevation MI (NSTEMI) has increased.
• Growing adoption in cancer-associated thrombosis management (e.g., prophylaxis in oncology patients).
• Off-label use facilitates broader market penetration.

Demographic Factors

Factor	Impact on Market
Aging Population	Higher incidence of thromboembolic events
Urbanization & Lifestyle Changes	Sedentary lifestyles increase risk factors
Healthcare Infrastructure Development	Better diagnostics lead to increased prescriptions

Regulatory and Policy Landscape

• FDA and EMA approvals for enoxaparin in various indications bolster market confidence.
• Reimbursement policies increasingly favor thrombosis management, driving prescription rates.

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What Are the Key Challenges and Risks Impacting Market Growth?

Challenges/Risks	Implications
Patent Expiry	Loss of exclusivity leading to generic competition [4]
Pricing and Reimbursement Policies	Variability limits accessibility in emerging markets
Hemorrhagic Risks and Contraindications	Affect perceived safety and prescribing patterns
Manufacturing Complexity	High manufacturing costs and potential supply chain disruptions
Market Penetration in Developing Regions	Regulatory barriers and economic constraints

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How Do Competitive Dynamics Shape the Market?

Major Players and Market Share (2022)

Company	Key Products	Estimated Market Share	Notable Initiatives
Sanofi (Lovenox)	Enoxaparin sodium	~45%	Expanding biosimilar portfolio; pipeline development
Mylan (Deyal)	Generic enoxaparin	~20%	Cost-effective offerings in emerging markets
Sandoz (Hexal)	Biosimilar enoxaparin	~15%	Focus on biosimilars; regulatory approvals
Other Regional Players	Various generics	20%	Market fragmentation, regional focus

Biosimilars and Generics

• The entry of biosimilars has significantly reduced prices and broadened access.
• Regulatory pathways in the US (BPCIA pathway) and EMA (EMA biosimilar guidelines) facilitate biosimilar approval.
• Biosimilar enoxaparins are projected to capture >35% of the global market share by 2025 [5].

Innovation and R&D Focus

• Development of reversal agents such as andexanet alfa enhances safety profiles.
• Research into long-acting formulations aims to reduce dosing frequency, improving compliance.

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What Is the Financial Trajectory of Enoxaparin Sodium?

Global Market Valuation and Forecast

Year	Market Size (USD Billion)	CAGR (2018-2025)	Key Growth Factors
2018	$4.2	—	Increasing thrombosis cases, expanding indications
2022	$6.1	8.4%	Adoption of biosimilars, new regulatory approvals
2025 (Forecast)	$8.5	9.2%	Market penetration in emerging economies, pipeline expansions

Source: MarketsandMarkets [6]

Regional Market Distribution (2022)

Region	Market Share (%)	Key Drivers
North America	35%	Advanced healthcare infrastructure, high awareness
Europe	30%	Aging population, strong regulatory frameworks
Asia-Pacific	20%	Emerging markets, rising healthcare spending
Rest of World	15%	Growing adoption, local manufacturing

Revenue Breakdown by Indication (2022)

Indication	% of Total Revenue	Major Trends
Thromboprophylaxis in surgery	40%	Leading driver, especially orthopedic surgeries
Treatment of DVT and PE	30%	Established market, increasing use in outpatient care
ACS and MI-related uses	15%	Growing with cardiovascular disease management
Other Off-label Uses	15%	Expanding, but less predictable

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What Are Future Market Opportunities?

Opportunity Area	Description
Biosimilar Expansion	Increasing approvals will reduce costs, expand access
Emerging Markets	Untapped growth, driven by healthcare infrastructure improvement
Oral LMWH Development	Research into oral formulations could revolutionize administration methods
Combination Therapy Approaches	Co-administration with antiplatelet agents or anticoagulants for broader indications
Digital Health Integration	Use of electronic health records and AI to optimize dosing and monitoring

Comparison of Enoxaparin Sodium with Other Anticoagulants

Parameter	Enoxaparin Sodium	Unfractionated Heparin	Direct Oral Anticoagulants (DOACs)
Route of Administration	Subcutaneous injection	IV or SC	Oral
Monitoring Requirements	Anti-Xa activity (optional)	PTT	None
Reversal Agent	Protamine sulfate	Protamine sulfate	Specific reversal agents available (e.g., idarucizumab, andexanet alfa)
Cost	Moderate (biosimilars reduce)	Low	Variable, typically higher
Indications	Thrombosis prophylaxis and treatment	Thrombosis, HIT	Broad indications, including stroke prevention

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Deep Dive into Regulatory and Policy Environment

Region	Key Policies and Guidelines	Impact on Market
United States (FDA)	Approved indications, biosimilar pathway, REMS programs	Facilitates market expansion
European Union (EMA)	Clear biosimilar pathway, national reimbursement policies	Accelerates biosimilar entry
Asia-Pacific (PMDA, CFDA)	Evolving regulatory standards, increasing approvals	Growing access in emerging economies
Emerging Markets	Reimbursement disparities, regulatory hurdles	Market entry challenges but growth potential

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Conclusion: The Long-Term Financial and Market Outlook

Enoxaparin sodium's market is poised for sustained growth, driven by demographic shifts, expanding clinical indications, and biosimilar competition. The global valuation is forecasted to reach approximately $8.5 billion by 2025, with key growth in North America, Europe, and emerging markets in Asia-Pacific.

The trend toward biosimilar adoption, coupled with ongoing R&D efforts to innovate delivery and safety profiles, will influence market share dynamics significantly. Companies that effectively navigate regulatory pathways, optimize manufacturing costs, and establish strategic partnerships will be best positioned to capitalize on this growth.

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Key Takeaways

• Market Growth: Expected CAGR of 9.2% from 2022 to 2025, driven by aging populations and expanding indications.
• Competitive Landscape: Dominance by Sanofi, with biosimilars capturing increasing market share.
• Financial Opportunities: Biosimilars and emerging market penetration represent significant revenue potential.
• Challenges: Patent expiries, safety concerns, and regulatory barriers necessitate strategic planning.
• Future Innovations: Oral formulations and digital health integration could redefine administration and monitoring.

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FAQs

1. How will biosimilars affect the enoxaparin sodium market?
Biosimilars are poised to significantly reduce costs and increase access, potentially capturing over one-third of the global market by 2025, thus intensifying competition and pressure on original product revenues.

2. What are the primary therapeutic indications for enoxaparin sodium?
Its core indications include thromboprophylaxis in surgical and medical patients, treatment of DVT and PE, and secondary prevention in atrial fibrillation and ACS.

3. What regulatory considerations are influencing market expansion?
Stringent approval pathways for biosimilars and safety monitoring programs, along with reimbursement policies, substantially impact market entry and growth trajectories across regions.

4. How does enoxaparin sodium compare to oral anticoagulants?
While enoxaparin requires injections and monitoring, DOACs offer oral administration without routine monitoring, which influences prescribing preferences based on patient compliance, safety, and cost considerations.

5. What are the main risks facing the enoxaparin sodium market?
Patent expiries, hemorrhagic risks, manufacturing complexities, and regulatory hurdles in emerging markets are key factors that could impede growth if not effectively managed.

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References

1. World Health Organization (WHO). Cardiovascular diseases prevalence, 2022.
2. American Heart Association (AHA). Pulmonary embolism statistics, 2022.
3. Global Burden of Disease Study, 2022.
4. FDA Biosimilar Pathway. Official guidelines, 2021.
5. EvaluatePharma. Biosimilar market forecasts, 2022.
6. MarketsandMarkets. Thrombosis market report, 2022.

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Note: Data is accurate as of the knowledge cutoff in early 2023 and should be supplemented with the latest industry reports and regulatory updates.