LOVENOX (PRESERVATIVE FREE) Drug Patent Profile

Which patents cover Lovenox (preservative Free), 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. Seventeen 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:	4
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
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	AP	RX	Yes	Yes

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
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-007	Jun 2, 2000
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	020164-002	Jan 30, 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/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

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
Japan	H04226101	MIXTURE OF LOW MOLECULAR POLYSACCHARIDES, AND ITS PREPARATION AND USE
Belgium	1006827	MELANGES DE POLYSACCHARIDES DE BAS POIDS MOLECULAIRES, PROCEDE DE PREPARATION ET UTILISATION.
World Intellectual Property Organization (WIPO)	8102737
Greece	910100270
Netherlands	9101049
Australia	540433
Australia	7928891

LOVENOX (PRESERVATIVE FREE) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lovenox (Preservative Free)

Introduction to Lovenox

Lovenox, also known as enoxaparin sodium, is a low molecular weight heparin (LMWH) used for the prevention and treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and other thrombotic disorders. It is a critical component in the management of cardiovascular diseases and has a significant presence in the global pharmaceutical market.

Market Size and Growth

The global enoxaparin API market, which includes Lovenox, is anticipated to experience substantial growth. By 2036, the market size is expected to reach USD 20 billion, growing at a Compound Annual Growth Rate (CAGR) of 8% during the forecast period of 2024-2036. In 2023, the industry size of enoxaparin API was already over USD 10 billion[1].

Driving Factors

Several factors are driving the growth of the enoxaparin sodium market, including:

Increasing Prevalence of Cardiovascular Diseases

The escalating incidence of cardiovascular diseases worldwide is a key driver. Sedentary lifestyles, unhealthy dietary habits, and an aging population contribute to the surge in cardiovascular ailments, creating an unprecedented need for effective anticoagulant therapies like Lovenox[1].

Regulatory Approvals and Market Dynamics

The increasing number of drugs approved by regulatory bodies such as the Food and Drug Administration (FDA) also boosts the market. These approvals enhance the credibility and availability of enoxaparin sodium, making it more accessible to patients[2].

Advanced Drug Delivery Technologies

The branded segment of the enoxaparin API market, which includes Lovenox, is expected to account for 60% of the global market share by 2036. This segment benefits from advanced drug delivery technologies, substantial investments in research and development, and premium pricing strategies. These factors contribute to the perceived value and trust in branded products, allowing them to maintain premium pricing even in the presence of generic competition[1].

Regional Market Analysis

North America

North America is expected to dominate the low molecular weight heparin market, including enoxaparin sodium, due to the growing burden of diseases and the rising geriatric population. For instance, the United States has a significant number of individuals aged 65 and above, which is projected to increase from 17.3% in 2022 to 22% by 2040. This demographic shift increases the risk of venous thromboembolism, thereby boosting the demand for LMWH products like Lovenox[4].

Asia-Pacific

The Asia-Pacific region is also expected to be a fast-growing market for enoxaparin sodium. The increasing healthcare expenditure, growing awareness of anticoagulant therapies, and improving healthcare infrastructure in this region contribute to its growth potential[4].

Key Players and Market Concentration

The enoxaparin sodium market is characterized by the presence of several key players, including Sanofi, Cardinal Health, Shenzhen Techdow Pharmaceutical, Teva Parenteral Medicines, and Actavis Pharma Company. These companies play a significant role in driving market growth through their research and development efforts, marketing strategies, and product innovations[2].

Financial Trajectory

Revenue Projections

The global enoxaparin sodium market was valued at USD 3.84 billion in 2023 and is projected to reach USD 9.23 billion by 2032, exhibiting a CAGR of 10.25% during this period. This significant growth is driven by the increasing demand for anticoagulant therapies and the expanding reach of branded and generic products[2].

Premium Pricing Strategies

Branded enoxaparin formulations, such as Lovenox, adopt premium pricing strategies due to their established safety profiles, rigorous clinical trials, and strong brand reputations. This allows these products to maintain high prices and contribute substantially to revenue growth[1].

Clinical Indications and Usage

Lovenox is indicated for various clinical uses, including:

• Prophylaxis of Deep Vein Thrombosis: In patients undergoing abdominal, hip replacement, or knee replacement surgeries, and in medical patients with severely restricted mobility due to acute illness[5].
• Treatment of Acute Deep Vein Thrombosis: In conjunction with warfarin sodium for both inpatient and outpatient treatments[5].
• Prophylaxis of Ischemic Complications: In patients with unstable angina and non-Q-wave myocardial infarction, when administered concurrently with aspirin[5].

Economic and Clinical Impact

Economic Attractiveness

While enoxaparin and low-dose heparin are equally effective, low-dose heparin is often more economically attractive for thromboembolism prophylaxis. However, the clinical benefits and safety profile of enoxaparin make it a preferred choice in many scenarios, despite the higher cost[3].

Clinical Benefits

Lovenox has been shown to reduce the rate of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) when administered concurrently with aspirin and other treatments[5].

Challenges and Considerations

Bleeding Risks

Patients treated with Lovenox need to be evaluated for bleeding disorders before starting treatment. Frequent monitoring for signs and symptoms of neurological impairment and bleeding is crucial[5].

Dose Adjustments

For patients with severe renal impairment, dose reductions are necessary to avoid adverse effects. This highlights the need for careful patient management and monitoring[5].

Key Takeaways

• The global enoxaparin API market, including Lovenox, is projected to reach USD 20 billion by 2036, growing at a CAGR of 8%.
• The increasing prevalence of cardiovascular diseases and the aging population are key drivers of market growth.
• Branded enoxaparin formulations, like Lovenox, maintain premium pricing due to their established safety profiles and brand reputations.
• North America is expected to dominate the market, while the Asia-Pacific region is anticipated to be a fast-growing segment.
• Lovenox is indicated for various clinical uses, including DVT prophylaxis and treatment, and the prophylaxis of ischemic complications in cardiovascular diseases.

FAQs

What is the projected market size of the enoxaparin API market by 2036?

The enoxaparin API market is anticipated to reach USD 20 billion by the end of 2036[1].

What is the CAGR of the enoxaparin sodium market from 2024 to 2032?

The enoxaparin sodium market is expected to exhibit a CAGR of 10.25% from 2024 to 2032[2].

Which region is expected to dominate the low molecular weight heparin market?

North America is expected to dominate the low molecular weight heparin market due to the growing burden of diseases and the rising geriatric population[4].

What are the key clinical indications for Lovenox?

Lovenox is indicated for the prophylaxis of deep vein thrombosis, treatment of acute deep vein thrombosis, and prophylaxis of ischemic complications in cardiovascular diseases[5].

How do branded enoxaparin formulations maintain their market position?

Branded enoxaparin formulations maintain their market position through premium pricing strategies, advanced drug delivery technologies, and strong brand reputations established through rigorous clinical trials and safety data[1].

Sources

1. Research Nester: Enoxaparin API Market Size & Share, Growth Trends 2036
2. Business Research Insights: Enoxaparin Sodium Market Size, Share, Growth To 2032 | Report
3. PubMed: Economic Analysis of Low-Dose Heparin vs the Low Molecular Weight Heparin Enoxaparin
4. Mordor Intelligence: Global Low Molecular Weight Heparin Market Size & Share Analysis
5. Sanofi US: Lovenox Prescribing Information