Amifostine Patent Expiration

Amifostine is Used for administering the drug product. It was first introduced by Legacy Pharma Inc Sezc in its drug Ethyol on Dec 8, 1995. 3 different companies have introduced drugs containing Amifostine.


Amifostine Patents

Given below is the list of patents protecting Amifostine, 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
Ethyol US5994409 Methods for treatment of neuro--and nephro--disorders and therapeutic toxicities using aminothiol compounds Dec 08, 2017

(Expired)

Legacy
Ethyol US5424471 Crystalline amifostine compositions and methods of the preparation and use of same Jul 31, 2012

(Expired)

Legacy
Ethyol US5591731 Crystalline amifostine compositions Jul 31, 2012

(Expired)

Legacy



Amifostine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Amifostine:

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.



Amifostine Generic API Manufacturers

Several generic applications have been filed for Amifostine. The first generic version for Amifostine was by Sun Pharmaceutical Industries Ltd and was approved on Mar 14, 2008. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Jul 17, 2017.

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