ENOXAPARIN SODIUM (PRESERVATIVE FREE) Drug Patent Profile
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Which patents cover Enoxaparin Sodium (preservative Free), and what generic alternatives are available?
Enoxaparin Sodium (preservative Free) is a drug marketed by Amphastar Pharm, Be Pharms, Gland, Nanjing King-friend, Sandoz, Shenzhen Techdow, and Zydus Pharms. and is included in seven NDAs.
The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) 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 (preservative Free)
A generic version of ENOXAPARIN SODIUM (PRESERVATIVE FREE) was approved as enoxaparin sodium by SANDOZ INC on November 28th, 2011.
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Summary for ENOXAPARIN SODIUM (PRESERVATIVE FREE)
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 15 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| DailyMed Link: | ENOXAPARIN SODIUM (PRESERVATIVE FREE) at DailyMed |
-patent-expirations.png "ENOXAPARIN SODIUM (PRESERVATIVE FREE) drug patent expirations")
Pharmacology for ENOXAPARIN SODIUM (PRESERVATIVE FREE)
| Drug Class | Low Molecular Weight Heparin |
US Patents and Regulatory Information for ENOXAPARIN SODIUM (PRESERVATIVE FREE)
| 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 | 205660-006 | Mar 15, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 077857-005 | Jul 23, 2010 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076726-007 | Jun 23, 2014 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Pharms | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076726-003 | 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 (PRESERVATIVE FREE)
| 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 |
