ENOXAPARIN SODIUM - Generic Drug Details
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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 |
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 |
Pharmacology for ENOXAPARIN SODIUM
Drug Class | Low Molecular Weight Heparin |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Be Pharms | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 214646-003 | Jun 6, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Be Pharms | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 214646-005 | Jun 6, 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 | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-008 | Jun 2, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-001 | Mar 29, 1993 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-007 | Jun 2, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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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