The role of genius is not to complicate the simple, but to simplify the complicated.
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"Who is making this presumption?"
That would be the FDA then everyone falls in line because of their presumption.
"I swear if a man's whisky or beer was even 10% diluted for a lesser price even, or reduced in volume, there would be rioting outside every bar and capital building across the nation, but dilute and substitute a man's Vascepa and no one gives a damn.
HK"
No one asked me, but if we were to take the 3rd party payers out of the system, forcing the consumer to always foot the entire purchase cost, it would be the same as your "whisky or beer" analogy.
Which goes back to my earlier point, vascepa is only less expensive than icosapent ethyl when the consumer introduces the coupon into the purchase transaction. and it is up to the consumer to be aware of, and utilize the coupon.
OT: crazy volume on acasti ACST for some unknown reason
I think there are two presumptions (accurate or not operating here in the supply chain.
1. The generic and the branded are sufficiently equivalent.
2. Given #1, most consumers will desire the lesser cost option, which is most often the generic.
Consumer beware! if you dont want generic, state so it the pharmacist.
"Is the pharmacist required to notify the patient of the switch, especially if the out of pocket cost (after Amarin's coupon is applied) is the same or if V is cheaper? "
I understand that awareness of the coupon is the patient's responsibility, not the pharmacy's/pharmacist's.
IPE was found to be cost effective with an incremental cost of $16,660 or $21,890 per QALY gained, respectively, which are both well below the most stringent typical criteria for assessing cost-effectiveness of medical therapy.
And retail price is now < $4000/yr!?!?
European Heart Journal - Cardiovascular Pharmacotherapy, pvaa128,
https://doi.org/10.1093/ehjcvp/pvaa128
Published:
02 November 2020
Bold move
"But based upon our view of the market opportunity, which is substantial, and based upon our -- both our experience with supply and knowledge and public comments from some of the generic companies, we believe that we can grow the market in the United States faster than what they can do in terms of supply in the market, probably good for everybody. "
.5M traded premarket, because of scripts?
"Unnecessary. The existence of direct infringement is not a question. But it is not enough, specific action should be proved also. "
So manufacturing of generic icosapent ethyl is not "specific action" but encapsulation, packaging and importation then ultimately consumption by patients with the reduce-it indication, is? Or is not?
I keep going back to production limits. If jointly the generic icosapent ethyl manufacturers produce more generic icosapent ethyl than is required to treat patients with triglycerides >500, the excess production is intended for sale to patients with the reduce-it indication.
Thanks to terrapharma on Twitter
https://m.scirp.org/papers/103416
Under the topic, I did not know this:
The generics are widely available and low priced pharmaceutical products but the quality of the main component and the composition of the additives are not fully transparent. Comparisons of the biological equivalence and long-term storage of the branded and generic products are performed **using parameters such as the maximum drug concentration, area under the blood concentration time curve and maximum drug concentration time.**
"gV
Must have 1g of icosapent ethyl. May not need to be 96% pure (we dont know this yet).
Inactive ingredients may differ."
What I understand you saying is, the capsule will be even larger than it already is?
"a sign on the shelf said "Omega-3's may be useful for DES" - I was pretty damn surprised by that!"
I've used vascepa daily for 7 yrs for dry eyes. Works well enough I dont need any eye drops.
Is that long buying or short covering, in 10k chunks premarket? Either way, the market is aware of a different risk level.
"@ Dancing I guess they will add the side effects but they don't need to add the data."
But see, that's my point. It's nonsensical to state on fhe generic label that "side effect xyz occurs in n% of the population" without explaining the population and why they were treated.
The population and why the population were treated is clearly REDUCE-IT data.
"I don't think infringement applies to side effects. "
Why would they add the side effect info to the label without the trial data that detected said side effect(s)?
"FDA sent Teva a letter in response to the de-listing of certain GSK patents from the Orange Book ..."
Sure would like to read that letter, is it public information? Who requested the "de-listing" and under what circumstances did the de-listing occur?
super simplification ...
If this case law holds through appeal,
Doesnt matter what (or how) you say to who about generic icosapent ethyl. if you produce more than is necessary to treat the skinny label patient population, you can be found to be inducing infringment on the other indication(s).
Sounds like a legal case where the generic manufacturer sue the insurers to recover a part of the treble damages incurred by the generic manufacturer when the insurers substituted generic for brand when the skinny label didn't allow that substitution.
Meanwhile the branded marketer already has their treble damages while the generics go after the insurers.
Consider this, if generic manufacturers assist in increasing the total sales of icosapent ethyl/ vascepa at no additional cost to amarin then amarin successfully sues for treble damages, has amarin generated more revenues than they would have otherwise with their own DTC and sales team?
Ya don't say ...
Teva argued that it could not be liable for induced
infringement because it had deliberately omitted, or
“carved out” from its 2007 label, reference to congestive
heart failure. Teva’s Rule 30(b)(6) witness, Director of New
Products Jennifer King, explained:
Question: So is the expectation of Teva that when
you carve out a particular indication, that Teva will
still get sales of that drug for that indication once
it’s launched its product?
Answer: It’s a legal strategy, not a commercial
strategy.
***
Question: And so to make it specific to the issues
here, if Teva has carved out congestive heart
failure, but not hypertension and not post MILVD,
Teva still expects to get sales where the doctor
prescribed carvedilol for congestive heart failure,
correct?
Answer: Yes, unless the doctor feels strongly.
Question: Writes brand only?
Answer: Yes.
Trial Tr., June 13, 2017, at 488.
“professional witness”
who is s/he?
can we find this witness, provide the full, uncropped table and ask if by reviewing the full table, they reach a contradictory opinion? and should they reach that contradictory opinion, request that they provide a written statement recanting their previous testimony.
such testimony could then be a part of marjac's miracle.
"- Again, I would look at this as a game of poker. You're the CEO of one of the Generics, not all. Do I want to sign supply guarantees up front and large enough to compete with Amarin's Generic? Generics are restricted to U.S. only. It's impossible. The CEO knows his Generic will peel off a fraction of Marine along with other Generics vying for share themselves?"
This brings to mind an interesting question: are the generic icosapent ethyl manufacturers building their own API making facilities or are they seeking to find existing facilities owned by others and contract production with them?
i don't know if this is IP for MND-2119, but it is mochida's patent
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=10,668,038.PN.&OS=PN/10,668,038&RS=PN/10,668,038
"Evidence could be carefully collected from various sources as to how generic sales infringe on the reduce it patents
The generics will of course be aware of this risk to them and it may colour their enthusiasm."
Evidence is readily available. This exercise could be fairly simple. Once generic icosapent ethyl Rxs exceed a threshold that accounts maximum treatable population of persons with triglycerides > 500 (reduced by lovaza and generic lovaza Rxs), then the generic icosapent ethyl manufacturers are producing a product intended to be used to treat an indication other than their skinny label.
https://www.iqvia.com/locations/united-states/solutions/commercial-operations/essential-information/prescription-information
i believe at some number of generic icosapent ethyl prescriptions filled it becomes obvious infringement on reduce-it IP must be occurring. why? because there are so few people with triglycerides > 500, many of who would never get a Rx. Also, a percentage of those persons will ALSO meet criteria for reduce-it indication.
this scenario must be a very uncomfortable one for generic manufacturers. why? because their business model is to endeavor to convert branded drug Rxs to their own manufactured generic alternative (as many as possible). but in this case, at a certain point, they convert too many and become susceptible to successful infringement claims and potential treble damages based upon the lost branded vascepa sales.
meanwhile, if amarin continues branded vascepa marketing to increase Rxs and the generic manufacturers successfully convert branded vascepa Rxs to generic icosapent ethyl, amarin is in effect accelerating just how quickly the generic manufacturers become reduce-it IP infringers.