Daiichi Sankyo the innovator for AZOR has filed a lawsuit in the U.S. District Court for the District of New Jersey alleging infringement of the sole patent U.S. Patent No. 5,616,599 relating to Azor® listed in the "Orange Book". The said patent is set to expire by Apr 25, 2016.
Mylan has confirmed the said news and believes to have a FTF (first to file) Para-IV status. As per the FDA record the said ANDA was filed on 11th Feb, 2008. This if true would make Mylan eligible for 180 days of exclusivity in case Mylan prevails and Daichi fails to defend its IP.
Sources:
http://www.news-medical.net/?id=38944
http://www.financialexpress.com/news/Daiichi-Sankyo-sues-Matrix-Lab/318888/
http://www.fda.gov/cder/ogd/ppiv.htm
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