LOVENOX (PRESERVATIVE FREE) Drug Patent Profile
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Which patents cover Lovenox (preservative Free), and when can generic versions of Lovenox (preservative Free) launch?
Lovenox (preservative Free) is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in LOVENOX (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 Lovenox (preservative Free)
A generic version of LOVENOX (PRESERVATIVE FREE) was approved as enoxaparin sodium by SANDOZ INC on November 28th, 2011.
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Summary for LOVENOX (PRESERVATIVE FREE)
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| DailyMed Link: | LOVENOX (PRESERVATIVE FREE) at DailyMed |
-patent-expirations.png "LOVENOX (PRESERVATIVE FREE) drug patent expirations")
Pharmacology for LOVENOX (PRESERVATIVE FREE)
| Drug Class | Low Molecular Weight Heparin |
Paragraph IV (Patent) Challenges for LOVENOX (PRESERVATIVE FREE)
| 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 LOVENOX (PRESERVATIVE FREE)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-001 | Mar 29, 1993 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-007 | Jun 2, 2000 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-004 | Mar 27, 1998 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-008 | Jun 2, 2000 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-002 | Jan 30, 1998 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-003 | Mar 27, 1998 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-005 | Mar 27, 1998 | AP | RX | Yes | Yes | ⤷ 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 LOVENOX (PRESERVATIVE FREE)
EU/EMA Drug Approvals for LOVENOX (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 |
International Patents for LOVENOX (PRESERVATIVE FREE)
See the table below for patents covering LOVENOX (PRESERVATIVE FREE) around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| France | 2663639 | MELANGES DE POLYSACCHARIDES DE BAS POIDS MOLECULAIRES PROCEDE DE PREPARATION ET UTILISATION. | ⤷ Sign Up |
| Czechoslovakia | 222245 | METHOD OF GAINING THE MUCOPOLYSACCHARIDES HAVING PARTICULARLY ANTICOAGULATION PROPERTIES | ⤷ Sign Up |
| Italy | MI911757 | ⤷ Sign Up | |
| Norway | 912485 | ⤷ Sign Up | |
| South Korea | 0185586 | ⤷ Sign Up | |
| Canada | 2045433 | MELANGES DE POLYSACCHARIDES DE BAS POIDS MOLECULAIRES; PROCEDE DE PREPARATION ET UTILISATION (LOW MOLECULAR WEIGHT POLYSACCHARIDE MIXES; PROCESS FOR THEIRPREPARATION AND USE) | ⤷ Sign Up |
| Israel | 62424 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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