Tamoxifen Citrate Patent Expiration

Tamoxifen Citrate was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Nolvadex on Approved Prior to Jan 1, 1982. Another drug containing Tamoxifen Citrate is Soltamox. 14 different companies have introduced drugs containing Tamoxifen Citrate.


Tamoxifen Citrate Patents

Given below is the list of patents protecting Tamoxifen Citrate, 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
Soltamox US6127425 Oral liquid medicine solution Jun 26, 2018

(Expired)

Mayne Pharma Commrcl



Tamoxifen Citrate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tamoxifen Citrate:

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
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2


Tamoxifen Citrate Generic API Manufacturers

Several generic applications have been filed for Tamoxifen Citrate. The first generic version for Tamoxifen Citrate was by Actavis Laboratories Fl Inc and was approved on Feb 20, 2003. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Aug 14, 2020.

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