Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

It could be Pfizer's legal strategy vs Elite

I do find it very bizarre that Troxyca has not launched yet.

There are a zillion possible reasons for a TRoxyca launch delay, but it could be legal strategy. Elite and Pfizer are going to battle it out in court. Pfizer will sue as soon as Elite files an application for either morphine or oxycodone with antagonist naltrexone. Both of Pfizer's NDA's are covered by the same patent (8,685,443). Their patent is for a "subunit" to sequester naltrexone while Elite's patents cover a separate naltrexone bead. In my opinion, Pfizer would rather fight Elite on the Embeda battleground than on Troxyca battleground, for several reasons.

First, Embeda has no remaining FDA exclusivity, while Troxyca has FDA exclusivity until Aug 19, 2019. Elite cannot market anything using Troxyca as RLD until at least then, but with application approval Elite could market generic Embeda immediately. Generic Troxyca is already tied up for 2&1/2 years by FDA, and Pfizer would be happy to tie up Embeda for a few years in court.

Not sure if any of that matters, but the other thing is that Troxyca has 1 listed patent with FDA while Embeda has 9 listed patents. Pfizer may feel more comfortable with that position. For whatever reason, it may be that Pfizer wants to force Elite's hand and will hold Troxyca until they see Elite's morphine ER application. Further, Nasrat may be doing a little head-fake. I'm not fully convinced there isn't going to be a surprise 505b2 NDA in our future instead of a string of ANDA's.

My 2 cents...






Embeda:
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022321&Appl_type=N

Troxyca:
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=207621&Appl_type=N