Loratadine Patent Expiration

Loratadine was first introduced by Bayer Healthcare Llc in its drug Claritin on Nov 27, 2002. Other drugs containing Loratadine are Claritin Hives Relief, Loratadine, Children'S Claritin, Claritin Reditabs, Claritin Hives Relief Reditab, Alavert. 33 different companies have introduced drugs containing Loratadine.


Loratadine Patents

Given below is the list of patents protecting Loratadine, 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
Claritin US6132758 Stabilized antihistamine syrup Jun 01, 2018

(Expired)

Bayer Healthcare Llc



Loratadine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Loratadine:

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
Effects of Inhibiting Early Inflammation in Kidney Transplant Patients National Institute of Allergy and Infectious Diseases (NIAID) NA COMPLETED
(Sep 1, 2026)
PHASE2


Loratadine Generic API Manufacturers

Several generic applications have been filed for Loratadine. The first generic version for Loratadine was by Pld Acquisitions Llc and was approved on Jan 21, 2003. And the latest generic version is by Sun Pharmaceutical Industries Ltd and was approved on Apr 25, 2025.

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