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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Summary for ENOXAPARIN SODIUM
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 10 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 48 |
| Drug Prices: | Drug price information 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Shenzhen Techdow | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 205660-007 | Mar 15, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076726-005 | 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 |
