LOVENOX Drug Patent Profile

When do Lovenox patents expire, and when can generic versions of Lovenox launch?

Lovenox is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in LOVENOX 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

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

Summary for LOVENOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	63
Patent Applications:	3,728
Drug Prices:	Drug price information for LOVENOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOVENOX
What excipients (inactive ingredients) are in LOVENOX?	LOVENOX excipients list
DailyMed Link:	LOVENOX at DailyMed

See drug prices for LOVENOX

See drug sales revenues for LOVENOX

Recent Clinical Trials for LOVENOX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fertility Center of Las Vegas	Phase 4
Regeneron Pharmaceuticals	Phase 2
Children's Healthcare of Atlanta	Phase 2/Phase 3

See all LOVENOX clinical trials

Pharmacology for LOVENOX

Drug Class

Low Molecular Weight Heparin

US Patents and Regulatory Information for LOVENOX

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	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	AB	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	AP	RX	Yes	Yes
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	020164-007	Jun 2, 2000	AP	RX	Yes	No
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	020164-002	Jan 30, 1998	AP	RX	Yes	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-006	Jun 2, 2000		DISCN	Yes	No

Expired US Patents for LOVENOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	4,692,435
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	RE38743
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	5,389,618

EU/EMA Drug Approvals for LOVENOX

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

See the table below for patents covering LOVENOX 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lovenox

Overview of Lovenox

Lovenox, also known as enoxaparin, is a low molecular weight heparin used primarily as an anticoagulant to prevent and treat thrombotic disorders associated with cardiovascular diseases. It is a key product in the portfolio of Sanofi, a major pharmaceutical company.

Market Size and Growth

The market for enoxaparin, including Lovenox, is anticipated to experience significant growth. By 2036, the enoxaparin API market is expected to reach USD 20 billion, growing at a CAGR of 8% during the forecast period of 2024-2036. This growth is driven by the increasing incidence of cardiovascular diseases globally, which has been identified as the leading cause of morbidity and mortality by the World Health Organization (WHO)[1].

Regional Market Performance

North America

North America dominates the enoxaparin market, driven by the high prevalence of cardiovascular diseases such as myocardial infarction and pulmonary embolism. The region also benefits from a strong presence of well-established market players and an increase in surgical procedures that require anticoagulant therapies[4].

Asia Pacific

The Asia Pacific region is expected to see significant growth in the enoxaparin market due to a large patient base with high unmet medical needs, improving healthcare infrastructure, and increasing awareness about cardiovascular health[4].

Financial Performance of Lovenox

Recent Trends

In the fourth quarter of 2023, Lovenox sales remained roughly stable, decreasing by only 0.3% to €263 million. However, this stability was achieved despite challenges from biosimilar competition and the impact of value-based procurement (VBP) in China, which were offset by growth in other countries[2].

Q1 2024 Performance

In the first quarter of 2024, Lovenox sales decreased more significantly by 13.9% to €262 million. This decline was attributed to the impact of volume-based procurement in China and increased biosimilar competition[5].

Impact of Biosimilar Competition

Biosimilar competition has been a significant factor affecting Lovenox sales. The entry of biosimilars into the market has led to increased competition, which has resulted in lower sales for Lovenox, particularly in regions like China and the U.S.[2][5].

Geographic Performance

China

In China, Lovenox sales have been impacted by volume-based procurement and biosimilar competition. Despite this, other Sanofi products like Toujeo have seen growth in China, with Toujeo's market share now exceeding that of Lantus[5].

Rest of the World

While Lovenox sales have been challenged in some regions, growth in other countries has helped mitigate these declines. The Rest of the World region has seen an increase in Lovenox sales, contributing to the overall stability of the product's revenue[2].

Competitive Landscape

The anticoagulant market is highly competitive, with several players offering both branded and generic versions of low molecular weight heparins. Sanofi faces competition from biosimilars, which are cheaper alternatives to branded drugs like Lovenox. This competition has forced Sanofi to focus on other strong-performing products in its portfolio, such as Dupixent and Beyfortus[2][5].

Strategic Initiatives by Sanofi

Sanofi has been focusing on transforming its portfolio to become more development-driven and tech-powered. This includes significant investments in late-stage pipeline projects and strategic acquisitions, such as the agreement with Inhibrx, Inc. These initiatives aim to offset the impact of biosimilar competition and ensure continued growth for the company[5].

Financial Metrics

Business Operating Income

In the fourth quarter of 2023, Sanofi's business operating income (BOI) decreased by 5.2% to €2,583 million, although it increased by 5.3% at constant exchange rates (CER). For the first quarter of 2024, BOI decreased by 14.7% to €2,843 million, with a decrease of 4.2% at CER[2][5].

Net Sales and EPS

Sanofi's net sales for the first quarter of 2024 were €10,464 million, representing a 6.7% increase at CER. However, the business EPS decreased by 17.6% to €1.78, reflecting various challenges including the impact of biosimilar competition and other market dynamics[5].

Key Takeaways

• The enoxaparin market, including Lovenox, is expected to grow significantly due to the increasing prevalence of cardiovascular diseases.
• Lovenox sales have been stable but face challenges from biosimilar competition and value-based procurement.
• Geographic performance varies, with growth in some regions offsetting declines in others.
• Sanofi is focusing on portfolio transformation and strategic initiatives to maintain growth.

FAQs

What is the expected market size for enoxaparin API by 2036?

The enoxaparin API market is anticipated to reach USD 20 billion by 2036, growing at a CAGR of 8% during the forecast period[1].

How has biosimilar competition affected Lovenox sales?

Biosimilar competition has significantly impacted Lovenox sales, particularly in regions like China and the U.S., leading to decreased sales despite overall market stability[2][5].

What are the key drivers of the enoxaparin market growth?

The key drivers include the escalating incidence of cardiovascular diseases worldwide, an increase in surgical procedures, and a strong presence of well-established market players in regions like North America[1][4].

How is Sanofi addressing the challenges faced by Lovenox?

Sanofi is focusing on transforming its portfolio, investing in late-stage pipeline projects, and making strategic acquisitions to offset the impact of biosimilar competition and ensure continued growth[5].

What is the current regional performance of Lovenox?

Lovenox sales have been impacted in China due to volume-based procurement and biosimilar competition, but growth in other countries has helped stabilize overall sales[2][5].

Sources

1. Research Nester: Enoxaparin API Market Size & Share, Growth Trends 2036
2. Sanofi: Press Release Q4 2023 English
3. Sanofi: Management guidance and previous commentary Business Q3 2022
4. Fortune Business Insights: Enoxaparin Market Size, Share, Trend, 2032
5. Sanofi: Press Release Sanofi Q1: robust 7% sales growth driven by...