Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Nope, not at all.

You're referring to Epic/Puracap's already approved generic Oxy (no ADT label), correct? You expect a good increase in revenues for Elite?

Think Elite will run HAL trials later in the year for the ADT Oxy BID generic they just referred to in the latest PR?

What I am saying is that Epic filed ANDA for generic OxyContin, which resulted in a patent infringement lawsuit from Purdue. Epic won the case. OxyContin, even if every one of their patents is ruled invalid, still has FDA exclusivity until August 2018. Every ANDA and NDA that uses OxyContin as RLD will be held up by the FDA until August 2018 because of the extra Pediatric indication that got tagged on to their label in August 2015. The ONLY EXCEPTIONS to Pediatric Exclusivity is either getting a waiver from Purdue or beating them in court in a patent suit. Hatch-Waxman specifically sets aside Pediatric Exclusivity if the ANDA applicant has successfully challenged the patents in court (successful Paragraph IV challenge).

So, like Collegium's Xtampza, the generic OxyContin ANDA that was filed by Epic IS NOT subject to the remaining 19 months of Purdue's FDA exclusivity. Epic/PuraCap could now receive a Full Approval for true generic OxyContin. It could happen any day and it would be a true generic, not Purdue-authorized. The only companies who are in a position for approval are the companies who challenged the patents in court. No one else can get through the iron-clad FDA exclusivity until August 2018, unless Purdue sues them and loses. This includes Teva, Amneal, Epic, and I think Mylan but not more than 5-6 will be eligible. Only a handful of companies will be FDA-approved to make true generic OxyContin for next 19 months!

Let's say PuraCap gets Full Approval of generic OxyContin next week. Nasrat has just demonstrated that starting the day of approval he can make commercial batches of generic OxyContin. He says he intends to file an ANDA application later this year, which I am sure is true. But what if the whole OxyContin bioequivalency exercise is to prepare for a manufacturing agreement with PuraCap for their generic OxyContin? If true, it could start producing AWESOME REVENUE within weeks of approval, which could be VERY, VERY SOON.