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. 9 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.

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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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Clinical Trials

Recent Clinical Trials on Levocarnitine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Studying the Effect of Levocarnitine in Protecting the Liver From Chemotherapy for Leukemia or Lymphoma Children's Oncology Group NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3


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 Baxter Healthcare Corp and was approved on Jul 2, 2026.

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