Antares Pharma, Inc. (ATRS)

[jbrhema]

SQ MTX market exclusivity – I have another question related to FDA regulation in the SQ MTX market:

• Is it a fact that no one else can enter the SQ MTX market in the U.S. for at least the next 30 months – or is it 30 months from ATRS approval of Oct. 2013 – i.e. is April 2016 the nearest window for a third competitor to enter?

My understanding is that:

• since there are now two approved FDA SQ MTX products, and
• any other SQ MTX product would likewise have to get FDA approval, and
• there is presumably no possibility of anyone else having a secret NDA or ANDA submitted prior to Oct. 2013 that would allow them to get unrestricted FDA approval such as Medac did,
• Is it true legally that anybody else trying to join this party will be required by the FDA to defer entering the U.S. market for 30 months minimum?

I just want to know if Medac and ATRS are the only ones allowed to play in the SQ MTX market for the next 30 months minimum. Thanks!