LOVENOX (PRESERVATIVE FREE) Drug Patent Profile

When do Lovenox (preservative Free) patents expire, and when can generic versions of Lovenox (preservative Free) launch?

Lovenox (preservative Free) is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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

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

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

Summary for LOVENOX (PRESERVATIVE FREE)

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	25
DailyMed Link:	LOVENOX (PRESERVATIVE FREE) at DailyMed

Pharmacology for LOVENOX (PRESERVATIVE FREE)

Drug Class

Low Molecular Weight Heparin

Paragraph IV (Patent) Challenges for LOVENOX (PRESERVATIVE FREE)

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 LOVENOX (PRESERVATIVE FREE)

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	020164-001	Mar 29, 1993	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-007	Jun 2, 2000	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-008	Jun 2, 2000	AP	RX	Yes	No

Expired US Patents for LOVENOX (PRESERVATIVE FREE)

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	020164-003	Mar 27, 1998
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

EU/EMA Drug Approvals for LOVENOX (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/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

International Patents for LOVENOX (PRESERVATIVE FREE)

See the table below for patents covering LOVENOX (PRESERVATIVE FREE) around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	8110736	PROCESS FOR OBTAINING MUCOPOLYSACCHARIDES AS HEPARINE DERIVATIVES
Poland	230237
Germany	2944792
Japan	S56501320

Market Dynamics and Financial Trajectory for LOVENOX (Preservative-Free)

Last updated: July 30, 2025

Introduction

LOVENOX, a low-molecular-weight heparin (LMWH) marketed by Sanofi, remains a prominent player in anticoagulation therapy. Its preservative-free formulation addresses safety concerns related to preservative-induced adverse reactions, particularly for sensitive patient populations. Understanding the evolving market dynamics and financial pathway for LOVENOX (Preservative-Free) is imperative for stakeholders assessing growth opportunities, competitive positioning, and investment viability.

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Market Overview

The global anticoagulant market is projected to reach approximately USD 30 billion by 2027, driven by increasing prevalence of thrombotic disorders and expanding indications beyond traditional venous thromboembolism (VTE) management. LMWHs, including LOVENOX, constitute a significant segment because of their proven efficacy, predictable pharmacokinetics, and ease of use in outpatient settings.

Key drivers influencing LOVENOX’s market position include:

• Rising incidence of cardiovascular diseases, deep vein thrombosis, pulmonary embolism.
• Increased adoption in surgical prophylaxis and cancer-associated thrombosis.
• Shifts towards formulation innovations, notably preservative-free options to mitigate allergic and skin reactions.

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Market Dynamics

Therapeutic and Regulatory Drivers

The shift towards preservative-free formulations like LOVENOX is propelled by regulatory and clinical considerations. Historically, preservatives such as benzyl alcohol were linked to neurotoxicity and hypersensitivity, especially in neonates and vulnerable populations [1]. Regulatory agencies and guidelines now favor preservative-free injectable medications, bolstering demand.

On the regulatory front, LOVENOX’s preservative-free variant benefits from approval pathways in multiple jurisdictions. These include stringent assessments of safety, efficacy, and quality, establishing a competitive advantage. The European Medicines Agency (EMA) and FDA have increasingly promoted preservative-free formulations, aligning with patient safety priorities.

Competitive Landscape

LOVENOX faces competition from other LMWHs (e.g., enoxaparin biosimilars, dalteparin, tinzaparin), direct oral anticoagulants (DOACs), and emerging biosimilar products. Biosimilars are predicted to amplify price competition, pressuring margins. However, preservative-free formulations may command premium pricing owing to perceived safety benefits, especially in pediatric, obstetric, or outpatient settings.

Market Penetration and Adoption

Adoption rates for LOVENOX premiums such as preservative-free variants are influenced by:

• Physician familiarity and clinical confidence.
• Institutional protocols favoring safety profiles.
• Reimbursement policies and insurance coverage.

In high-income regions like North America and Europe, prescriber preferences lean favorably towards preservative-free options. Conversely, emerging markets may exhibit slower uptake due to cost sensitivities, although domestic regulatory approvals are increasing.

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Financial Trajectory

Revenue Streams and Growth Potential

LOVENOX’s revenues have historically grown in line with the expanding anticoagulant market. The preservative-free variant forecasts an upward trajectory fueled by safety-driven prescribing:

• Market acceptance is expected to grow as clinical guidelines explicitly advocate for preservative-free anticoagulants in certain populations.
• Pricing strategies can leverage the premium safety profile, especially in hospital and outpatient settings.
• Geographic expansion into Asia-Pacific, Latin America, and Africa offers additional growth avenues, contingent upon regulatory approvals and healthcare infrastructure development.

Cost Dynamics and Profitability

Product costs for LOVENOX encompass manufacturing, quality control, regulatory compliance, and distribution. The preservative-free formulation involves complex manufacturing processes, potentially increasing costs. However, economies of scale and process optimization could mitigate this expense.

Profitability hinges on balancing pricing premiums against volume growth. With biosimilar competition intensifying, margins may face pressures, emphasizing the need for efficient supply chains and differentiated value propositions.

Impact of Biosimilar Competition

The entrance of biosimilars, such as MoojSurvey’s enoxaparin variants in key markets, will likely compress LOVENOX’s therapeutic pricing. Nonetheless, the preservative-free aspect, alongside established safety data and brand recognition, could sustain a premium segment for LOVENOX.

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Future Outlook and Strategic Considerations

Innovation and pipeline development remain critical. Sanofi’s efforts to extend LOVENOX’s indications into COVID-19-associated thrombosis or prophylaxis could expand revenue streams.

Regulatory agility is essential to maintain market share amid increasing biosimilar entries and generic options. Capitalizing on safety data and patient-centric formulations positions LOVENOX favorably.

Partnerships and alliances with healthcare systems and payers can expand access and reimbursement, bolstering market penetration. Education campaigns emphasizing the safety benefits of preservative-free formulations can accelerate clinician adoption.

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Risks and Challenges

• Price erosion driven by biosimilar competition.
• Regulatory hurdles restricting approval or reimbursement in new markets.
• Local healthcare policies influencing prescribing behaviors.
• Clinical evidence requirements for expanded indications.

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Key Takeaways

• LOVENOX’s preservative-free variant addresses critical safety concerns, positioning it favorably in a growing anticoagulant market.
• Adoption hinges on regulatory approvals, clinical acceptance, and healthcare policies favoring safety enhancements.
• Competition from biosimilars and DOACs presents pricing and market share challenges, necessitating continuous innovation.
• Revenue growth is expected from geographic expansion, expanded indications, and increased demand for safety-assured formulations.
• Strategic focus on cost control, regulatory navigation, and stakeholder engagement is essential to maximize financial trajectory.

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FAQs

1. How does LOVENOX’s preservative-free formulation provide a competitive advantage?
It mitigates risks of hypersensitivity and neurotoxicity associated with preservatives, making it preferable for sensitive populations and aligning with regulatory trends emphasizing patient safety.

2. What markets show the greatest potential for LOVENOX’s growth?
Developed markets such as North America and Europe lead adoption due to established safety profiles, with emerging markets promising expansion as regulatory approvals and healthcare infrastructure improve.

3. How will biosimilar competition influence LOVENOX’s pricing strategy?
Biosimilars will exert downward pressure on prices; however, LOVENOX can offset this through its safety differentiation and established brand trust, possibly maintaining a premium segment.

4. What regulatory hurdles does LOVENOX face in expanding its indications?
Approval depends on robust clinical trial data demonstrating safety and efficacy for new uses. Regulatory authorities may require extensive evidence, particularly in vulnerable patient groups.

5. What strategic actions should Sanofi undertake to sustain LOVENOX’s market position?
Prioritize pipeline development, enhance clinician and payer education on safety benefits, pursue pipeline approvals in emerging markets, and foster partnerships for better market access.

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Sources:

[1] PubMed Central. “Preservative Toxicity in Parenteral Drugs: Safety Considerations,” 2021.