Nice post big dog.
I think (on this occasion anyway) that I agree with Carter in that the Insys provisional application is a bit too similar to those held under granted Oromist patents. Their lawyers argument might be along the lines that the pH's are fundamentally different, Insys is 4.5 and SUD is <2.5, so that might be a bone of contention.
By the way there's nothing like a bit of drama and Insys were in the middle of it last year, fyi.
http://www.nbcnews.com/business/bus...ompany-putting-profits-above-patients-n457511
http://www.cnbc.com/2015/11/05/ceo-of-controversial-drug-company-insys-is-out.html
There are also some components of the Insys formulation that aren't in Oromist, permeation enhancers (lo and behold caprylic acid) and the like. The formulations in 4F and 4C in the chart below seem to be the most effective over the longer term anyway. The addition of Malic acid in 4C is an interesting inclusion instead of HCl.
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But here's the kicker.
SUD3.2 after 60 mins created levels of 160 mcg/ml in the receptor vessel of the Franz cell. The Insys formulation was (about) 10 mcg/ml. Interestingly SUD 3.1 also had about 10 mcg/ml after 60 mins.
![]()
If the unscientific representation (from SUD) is even half accurate then the Insys formulation shouldn't pose any threat.
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