Levocarnitine Patent Expiration

Levocarnitine is Used for treating and preventing carnitine deficiency in end stage renal disease patients undergoing dialysis. It was first introduced by Leadiant Biosciences Inc in its drug Carnitor on Dec 27, 1985. Another drug containing Levocarnitine is Carnitor Sf. 7 different companies have introduced drugs containing Levocarnitine.


Levocarnitine Patents

Given below is the list of patents protecting Levocarnitine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Carnitor US6335369 Treating chronic uremic patients undergoing periodical dialysis Jan 18, 2021

(Expired)

Leadiant Biosci Inc
Carnitor US6429230 Treating chronic uremic patients undergoing periodical dialysis Jan 18, 2021

(Expired)

Leadiant Biosci Inc
Carnitor US6696493 Treating chronic uremic patients undergoing periodic dialysis Jan 18, 2021

(Expired)

Leadiant Biosci Inc



Levocarnitine's Family Patents

Family Patents

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Levocarnitine Generic API Manufacturers

Several generic applications have been filed for Levocarnitine. The first generic version for Levocarnitine was by Teva Pharmaceuticals Usa and was approved on Mar 29, 2001. And the latest generic version is by Novitium Pharma Llc and was approved on Dec 9, 2022.

Given below is the list of companies who have filed for Levocarnitine generic, along with the locations of their manufacturing plants worldwide.


1. AM REGENT

American Regent Inc has filed for 1 generic for Levocarnitine. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

injectable Prescription INJECTION AP Jun 22, 2001





2. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Levocarnitine. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

injectable Prescription INJECTION AP Mar 29, 2001
1GM/10ML

solution Discontinued ORAL N/A Oct 25, 2007


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





3. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 2 different strengths of generic version for Levocarnitine. Out of these 1gm/10ml version comes by the name LEVOCARNITINE SF. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/10ML

solution Prescription ORAL AA Aug 14, 2019
330MG

tablet Prescription ORAL AB Dec 9, 2022


Manufacturing Plant Locations
New

Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC





4. RISING

Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Levocarnitine. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/10ML

solution Prescription ORAL AA Aug 10, 2004
330MG

tablet Prescription ORAL AB Sep 20, 2004


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Rising Sun Rising Sun Veterinary Clinic
Fort Bragg Rising Tide Sea Vegetables
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Livingston Risingsun Iodine Products Corp.
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





5. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Levocarnitine. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM/10ML

solution Prescription ORAL AA Nov 10, 2021





6. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Levocarnitine. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/ML

injectable Discontinued INJECTION N/A Mar 29, 2001