Elite Pharmaceuticals Inc (ELTP)

[lasers]

The FDA Commissioner Gottlieb is obviously very aware now as to why Pfizer has not yet launched Troxyca, 18 months after the FDA approval in Aug 2016.

I’ve bucketed this focus of our attention into three areas. First, sometimes the lack of competition is a result of branded drug makers that game the system, usually in ways that block the ability of generic drug makers to run the studies needed to win FDA approval.

We’ve been focused, in particular, on tactics branded drug makers adopt to block generic drug makers from amassing the physical doses of the branded drug that the generic firms need in order to run the bioequivalence studies that FDA requires for approval.

https://www.fda.gov/NewsEvents/Speeches/ucm586643.htm




$ELTP latest CC Nov 11 2017

NH

Regarding anti-abuse extended release formulations, the most lucrative is Oxy ER. There is a tablet OxyCoton and capsule Pfizer’s product that have not been launched. We fight for the generic OxyCoton because we can. As for Pfizer’s product we cannot yet, because they have not launch, in addition they have freeze exclusivity and they are through one year of the street.
We can file the product while they have exclusivity, we cannot market it after that. However, we cannot file till they launch and they have not launched. We need Pfizer to launch in order for us to compare their profile to ours and conduct the BE study without that we cannot submit an application, we cannot create an application.