The pharma major, Sun Pharmaceutical Industries Ltd has recently announced the launching of its generic version of the Amifostine Injection 500 mg in the US market. The officials of the company have stated that he generic Amifostine is having therapeutic equivalence to the Ethyol of MedImmune. The Ethyol is actually a medicine that is generally used as an adjunct to the cancer therapy, for protection against the side-effects of chemotherapy and radiation treatment.
The officials of the company have stated that this launch in the US has been announced, in spite of the Sun Pharma remaining locked in a patent-infringement suit with the MedImmune, for more than three years now. According to an official statement released by the Sun Pharma, the Ethyol is covered under three patents that are the 471 up to July 31, 2012, 731 up to July 31, 2012, and 409 till December 08, 2017. The company said, this has abbreviated that the new drug application (ANDA) was filed with para IV certification, that involved a patent challenge against all the patents MedImmune filed and the case is still under litigation in a US Court.
The statement added that the Sun Pharmas product is being sold in the US market through its marketing partner Caraco Pharmaceutical Laboratories. The statement further informed that the company did get the regulatory US Food and Drug Administration (USFDA) approval for this product in the month of March. The industry sources have stated that the annual sales of Ethyol is about $80 million in the US and as the Sun Pharma is the first-to-file an ANDA for generic Ethyol with a para IV certification, it is having a 180-day marketing exclusivity when it sales the drug in the US market. During this period, no other generic drug company will have the permission to launch its version of generic Amifostine from the date that Sun Pharma had launched its version of the same drug in the US.
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| Posted : 4/2/2008 |
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