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Last Updated: November 2, 2024

ENOXAPARIN SODIUM Drug Patent Profile


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

Enoxaparin Sodium is a drug marketed by Amphastar Pharms Inc, Nanjing King-friend, Sandoz Inc, Amphastar Pharm, Be Pharms, Gland, Sandoz, Shenzhen Techdow, and Zydus Pharms. and is included in ten NDAs.

The generic ingredient in ENOXAPARIN SODIUM 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 Enoxaparin Sodium

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

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Drug patent expirations by year for ENOXAPARIN SODIUM
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Recent Clinical Trials for ENOXAPARIN SODIUM

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SponsorPhase
PT Bio FarmaPhase 4
Imperial College LondonPhase 4
Loewenstein HospitalN/A

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Pharmacology for ENOXAPARIN SODIUM
Medical Subject Heading (MeSH) Categories for ENOXAPARIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes 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
Shenzhen Techdow ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 205660-003 Mar 15, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 077857-002 Jul 23, 2010 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms ENOXAPARIN SODIUM (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 076726-004 Jun 23, 2014 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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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