Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

The judge didn't sided with Pfizer, because the litigation was dismissed by both parties... in fact, if anything, it was in favour of Watson because the litigation was dismissed with 'prejudice', which means Pfizer cannot sue Watson again for this.

Okay, I think I'm getting it. So after "Judge Andrews adopted plaintiffs’ proposed construction" there was a settlement which favored the defendant. The settlement was so favorable to the defendant that they agreed not to do the thing that caused them to be sued, and six years later they still haven't.

Maybe if you read more about this deals you would realise how this works, because Watson/Actavis/Teva are the manufacturers of Embeda for Pfizer, they are and have been for the last 8 years, so the deal just brings money to Teva while they pursue their ANDA.

Again thanks so much for helping us to understand "how this works." I really think I'm starting to get it. The above-mentioned settlement, which occurred soon after the judge adopted the plaintiff's construction, was so favorable to the defendant that they were allowed to continue with the mutually beneficial contract manufacturing agreement that was previously negotiated and in place for two years before they were sued. I think I'm getting it...

If you haven't seen an approval yet it is because Embeda was discontinued in 2011 until 2015, then it got its AD label in 2015... so other things happen thru these years that delayed any Gx Embeda

I'm going to need some more of your awesome help to understand how this part works. Embeda's stability issues in 2011 and then its ADF label in 2015 is what caused FDA to delay approval of Watson's ANDA, which they otherwise would have approved by now, and even years later, in 2018, still have not approved. Maybe a link could be provided to support this idea, maybe even a link that does not go to corporate search engine results but rather to an actual statement of fact by somebody that supports this idea.

and as a note for all of those who wonder why there are no Gx ADFs yet, it is because FDA is waiting for the post-marketing studies from the current branded ADF to prove they work before they go and approve generics ;)

Yep, this makes perfect sense. Unsure of their effectiveness, the FDA has decided to give the brand name drugs de facto exclusivity against cheaper generic competition until the brand names decide to submit post-marketing data. I guess we can forget about all the public pronouncements by the FDA about their desire to see generic ADF's, and I'll just stop reading the 30+ page Guidance for Industry on generic ADF's that the FDA published just 3 months ago.



What I really wonder is this: does this stuff come out of the bull's ass in the fully-formed steaming piles that appear on this message board, or does it come out of the bull's ass in a more sloppy, splashy diarrheal admixture that must be cured and formed before posting?






https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586117.htm

One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.

In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids.

https://www.fda.gov/downloads/Drugs/.../Guidances/UCM492172.pdf

General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products

Guidance for Industry

November 2017