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Website updated, Adderall moved from pipeline to products section.
https://www.elitepharma.com/products/
Correct.
I looked around a little... saw 1.3 and 1.4 billion in some headlines.
Mylan launched their Concerta generic in late December, 2016. They reported $1.56 billion in IMS sales as of October 2016.
The market size is growing.
http://newsroom.mylan.com/2016-12-29-Mylan-Launches-Generic-Concerta-Tablets
Interesting, thanks!
How much does a PR cost?
Haha sure. That explains the excellent patient retention rate..... oh wait, it actually doesn’t. LOL.
Thanks for your data. My 8 interns have also arrived at the same conclusion. They will be publishing the top line results soon.
Nvm, about 3 months to the day.
Whew! Mad money on that one. Hopefully they have it launched ASAP.
How long did it take us to go from Methadone approval to launch?
The previous set of generics were indeed breadcrumbs when discussing their market potentials. I don’t think anyone seriously disputes this. A generic with brand/generic market with total sales of 40M and less is not a huge deal. However, a drug with a 400M, 700M, 1.6B market? Yeah, that’s big. Elite has multiple approvals like these now. Comparing the “old” generics to the majority of the approvals and filings of the recent 2 years or so is apples and oranges.
For SequestOx, there have been missteps on Elite’s part as well as goalpost-moving guidance from the FDA.
Isradipine is an extra, gravy, icing on the cake. Maybe it turns into a surprise double/triple, maybe not. What is most certainly happening is the approval and launch of generics with massive markets.
A company/stock “valued to have potential” and actually having potential are not always the same thing. You will see Elite demonstrate this in a positive way going forward.
Given the info in your post about the Percocet process from approval to launch, at what point would you get the impression that Elite is falling behind? Is there a rough date range in mind of when you think the drug should be launched by?
Does absolutely nothing to address my point... LOL.
Fact - we heard here that Elite couldn’t get ANDAs approved but that is demonstrably false like I said it was.
Remember when we heard that Elite couldn’t get the pending ANDAs approved?
Funny how we don’t hear that anymore, eh?
Bingo.
Remember the flash crash? That happened because all those companies started doing really shitty for a few minutes and then quickly recovered, which allowed their stocks to recover as well.
“We filed two other ANDAs earlier this year. One is the ANDA of an immediate release CNS product that we co-developed with our partner SunGen, for which there is a brand and generic sales of approximately $400 million.
Elite is hopeful that this product will be approved in December of this year. That is our PDUFA date. We will wait to hear from FDA. The second ANDA is an extended release CNS product that we co-developed with our partner SunGen. The brand and generic sales of that product, the extended release version is $1.6 billion.
There are currently four manufacturers including the brand and the authorized generic. We are expecting approval and launch in Q2 of 2018.”
Pretty sure he said they expect another approval in December for that one..
“Elite currently has five additional ANDAs filed with the FDA, **will be launching three additional products shortly through our Glenmark marketing alliance**, and is continuing development of additional pipeline products.”
Indeed.
Ah ok. So combo products like Oxy/APAP don’t get the stay, right?
That stay is triggered on combination Oxy products? I thought it was just plain OxyContin or generic oxycodone competition but I admittedly don’t know much about that part of the process.
That’s how this PR reads but I don’t think that is correct. I thought Methadone by itself had IMS numbers in the neighborhood of ~40M annually, give or take. Maybe they mean 4 of the Epic drugs pull 34M + Methadone’s ~40M?
Huh????
Agree that they need to move on the approvals we already have. Methadone needs to be launched like yesterday.
au·gust
adjective
respected and impressive.
"she was in august company"
synonyms: distinguished, respected, eminent, venerable, hallowed, illustrious, prestigious, renowned, celebrated, honored, acclaimed, esteemed, exalted; More
Too ez.
Correct. A very expensive brand name Morphine or Oxycodone that has no true ADF and thus people go with the generics instead. Same with Apadaz I think.
What are you expecting?
Wrong.
Laser? Inkjet? Thermal?
Wrong.
No innuendo. Nasrat stated two or three weeks ago that Methadone launch was weeks away. Not hard to grasp.
Think we see a Methadone launch this week or not until sometime in September?
Fatmi causing PANIC for some folks. LOL.
Except it doesn’t. lol
Not that far off either though. We’ll be in 2019 before we know it. Approve approve approve, launch launch launch!
Haha GOT EM. Absolutely correct. Pharmas have been bought out with zero approved drugs.
LOL. Well done.
Me too.
That was the last of contract manufacturing for Elite, per their website. Also, if the website is correct, we were just contract manufacturing 10mg tablets of Methadone. With our newly approved ANDA, we’ll be making both 5mg and 10mg tablets for Glenmark.
Yessir. Ready to see for sure if WeeZhul is correct on these CNS drugs Elite filed this year as well. Lots of drugs for them to start pumping out over the coming months as approvals continue to roll in.
We also get the Mikah drugs back from limbo with Epic in about a month and a half I think.
The problem was never the naltrexone “half” of the formulation to begin with, though.