Antares Pharma, Inc. (ATRS)

[jbrhema]

Bio-Pete - and MTX market exclusivity.

Thanks for the answer, but it still does not seem to have answered my basic question - which is - is there any legal possibility of anyone else entering this market before April 2016?

My understanding of some of Td's posts about this issue is that anyone else will have FDA approval delayed for 30 months before they can enter the market.

That is - suppose someone has indeed already filed or soon plans to file an ANDA and we do not know. Is it not the case that the FDA needs to respond back within 10 months? So that the fact we have seen no such FDA PDUFA date announcement - and presumably we will not see an announcement prior to August 11, 2014 [10 months after ATRS approval on Oct. 11, 2013] - means conclusively that any such hypothetical ANDA will have been filed *after* ATRS got their approval? And so any such ANDA will receive at best a tentative approval and cannot market the product until April 2016 at the earliest?

Again - sorry for my ignorance about the details of FDA regulations in this arena - so can someone educate me how this works?

Reason for my question - if ATRS and Medac are the only players allowed in the sand box until April 2016, that has to my mind positive implications for the level of Otrexup sales by the end of 2015.