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Last Updated: January 27, 2023

Enoxaparin sodium - Generic Drug Details


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What are the generic sources for enoxaparin sodium and what is the scope of patent protection?

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, Apotex Inc, Sandoz, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for enoxaparin sodium. Fifteen suppliers are listed for this compound.

Drug Prices for enoxaparin sodium

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Recent Clinical Trials for enoxaparin sodium

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SponsorPhase
Loewenstein HospitalN/A
University Magna GraeciaN/A
Venus Remedies LimitedPhase 1

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Pharmacology for enoxaparin sodium
Medical Subject Heading (MeSH) Categories for enoxaparin sodium
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
Sandoz ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857-003 Jul 23, 2010 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076726-001 Jun 23, 2014 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 078990-001 Sep 28, 2018 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-003 Mar 27, 1998 AP RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nanjing King-friend ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 206834-006 Nov 29, 2019 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-008 Jun 2, 2000 AP RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for enoxaparin sodium

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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