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:	62
Patent Applications:	3,282
Formulation / Manufacturing:	see details
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
Regeneron Pharmaceuticals	Phase 2
Medical College of Wisconsin	Phase 2/Phase 3
BJC HealthCare	Phase 2/Phase 3

See all LOVENOX clinical trials

Pharmacology for LOVENOX

Drug Class

Low Molecular Weight Heparin

Anatomical Therapeutic Chemical (ATC) Classes for LOVENOX

B01AB	Heparin group
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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

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
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003

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
Spain	2036922	PROCEDIMIENTO DE OBTENCION DE MEZCLAS DE POLISACARIDOS DE BAJOS PESOS MOLECULARES.
Sweden	449753	MUKOPOLYSACKARIDKOMPOSITION MED REGLERANDE VERKAN PA KOAGULATION, LEKEMEDEL INNEHALLANDE DENSAMMA SAMT FORFARANDE FOR FRAMSTELLNING DERAV
U.S.S.R.	1658820	CПOCOБ ПOЛУЧEHИЯ MУKOПOЛИCAXAPИДOB (METHOD FOR PREPARING MUCOPOLYSACCHARIDES)