Showing posts with label ANDA. Show all posts
Showing posts with label ANDA. Show all posts

Wednesday, July 2, 2008

Teva to appeal U.S. District Courts decision over Quetipine

AstraZeneca PLC has won the initial battle over its antipsychotic drug Seroquel, removing the threat of generic competition for the company's second-best-selling product with $4 billion in sales in 2007 after Nexium.

In addition to this AstraZeneca PLC has also sued Sandoz for filing ANDA. Both Teva and Sandoz are in race for generic version of Seroquel and seek approval to market generic versions of SEROQUEL® (quetiapine fumarate tablets) in the US before SEROQUEL's US patent 4879288 expires in Sep. 2011.

For further details refer Wall Street journal and CNN money at
http://online.wsj.com/article/SB121495435431321131.html?mod=googlenews_wsj
http://money.cnn.com/news/newsfeeds/articles/apwire/851476d46341f0e43802c566ca32b121.htm

Thursday, June 5, 2008

Matrix Labs Sued For AZOR –PARA-IV

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