Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

4. Epic does NOT market a generic of Oxycontin

This is exactly right, but it is also true that Epic could be marketing generic OxyContin any day. Epic (now PuraCap) is one of four companies who have beaten Purdue in the highest courts. This should qualify these companies for a bypass around OxyContin's Pediatric Exclusivity, which is otherwise in effect until August 2018. If true, Epic could be one of a small handful of companies with true generic OxyContin. I wrote the post below in January 2017, shortly after Elite PR'ed the pivotal BE for OxyContin. I believed then and still believe that if and when the Epic ANDA for generic OxyContin receives full approval that Elite will be the manufacturer of the drug for PuraCap.


The Supreme Court decision against Purdue was November 2016, so now is about the right amount of time for a complete FDA review cycle to have gone by. Since then, Purdue has added several patents to the Orange Book, and they have used these late-listed patents to vigorously defend their product, apparently with good success. I'd be shocked if Elite's ANDA filing doesn't result in a patent suit citing the newer patents, with an automatic 30 month stay. But there are four companies who have already been through the process and have gotten closer than all others. On any day going forward, one or all of these companies, including Epic/PuraCap, could find themselves with full approval to market generic OxyContin. As of now, the Elite factory is updated for production capacity and is ready to pump out generic OxyContin immediately.






https://investorshub.advfn.com/boards/read_msg.aspx?message_id=128027166

WeeZuhl Friday, 01/20/17 08:56:19 PM
Re: Mazeppa post# 239819
Post # 239843

So just as you said, Maz, connect the dots; two birds, one stone. November 14 is when Epic (PuraCap) put the final nail in the Purdue patent litigation when the Supreme Court refused to hear the case. If there was a pre-existing agreement between Elite & PuraCap, it was November 14th when both parties would have known that things need to start moving forward. According to the PR, Elite had already done a pilot study (presumably with the Epic formula).

When they got word from PuraCap in November, they knocked out the pivotal study and here is where they killed 2 birds with one stone. They collected the data they need for their own ANDA application later this year, and they also proved to PuraCap that they are ready to start pumping out commercial batches of generic OxyContin as soon as the Epic ANDA gets Full Approval.