ENOXAPARIN SODIUM - Generic Drug Details

What are the generic drug sources for enoxaparin sodium and what is the scope of freedom to operate?

Enoxaparin sodium is the generic ingredient in four branded drugs marketed by Amphastar Pharms Inc, Nanjing King-friend, 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. Seventeen 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:	17
Clinical Trials:	48
Drug Prices:	Drug price trends for ENOXAPARIN SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
PT Bio Farma	Phase 4
Imperial College London	Phase 4
Loewenstein Hospital	N/A

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	076684-006	Sep 19, 2011	AP	RX	No	No
Shenzhen Techdow	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	205660-004	Mar 15, 2023	AP	RX	No	No
Shenzhen Techdow	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	205660-003	Mar 15, 2023	AP	RX	No	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-001	Mar 29, 1993	AP	RX	Yes	No
Amphastar Pharm	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076684-005	Sep 19, 2011	AP	RX	No	No
Zydus Pharms	ENOXAPARIN SODIUM (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	076726-002	Jun 23, 2014	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	020164-004	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	020164-003	Mar 27, 1998
Sanofi Aventis Us	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003
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	020164-006	Jun 2, 2000

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/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