I agree it's a good business plan as a solo participant in the market, but as a second or third entrant, probably less so-- depending on IP around the formulation and delivery method.
With the number of company with discontinued products in the Orange book, i suspect there is some economic burden.
Sounds similar to what happened to Epipens- the drug is long out of patent, but the injector/delivery system gets continual minor tweaks to stay proprietary.
Between the FDA and patent lawsuits, good luck doing this in the US. Several major drug companies have already failed miserably and Adrenaclick isn't anywhere near the huge success you apparently think it would be.
I was looking into this and haven't seen much news of late. This would be an amazing product if widely available. Unfortunately knowing the current state of US pharmaceuticals, this would cost the price of your mortgage.
Since the document links for a similar therapy for a similar illness, and links a few studies in animal of similar approach, why do you think that big pharma is not planning to do this in a few years?
The drug patent has long expired. It is an autoinjection mechanism that is patented. There have been many competitors in the market but some got recalled due to flaws.
That just raises more questions. Are these "newer formulations" a meaningful improvement over everything else (in particular those for which patents have expired) created during the past 97 years, as opposed to ploys to maintain IP? The tactic involved here is using regulatory capture, near monopoly control of supply and IP law to limit what is available for prescription use to expensive products.
The model yielded nine drugs considered likely to provide those therapeutic benefits, three of which are currently in use – meaning the analysis identified six candidates for drug repurposing
Quite interesting! Was wondering if/how this novel approach could be translated into a business. Maybe it earns referral $ if the drug candidate can be successfully repurposed and also does it mean that the IP is protected for another 20 years?
The patent on this specific drug has already expired. It is just that the demand is low so that it is not cost effective for a competing manufacturer to get FDA approved. However there are FDA exceptions for compounding pharmacies to make the medicine to order and a particular one has been willing to do it cheaply since they don't need full FDA approval.
I was expecting this to end with the usual "using this to treat patients in clinical settings is at least 10 years away" (read: probably never) but this one is actually available now it looks like, although it's very pricey at $3-4000.
I don't think the FDA is the real problem on this one. There is a known treatment whose patents have expired, however for now nobody is willing to manufacture it.
The specific mechanism Mylan markets is covered by a patent. Some adjustment to the way the needle cap operates.
Of course that patent doesn't prevent other epinephrine autoinjectors from coming to market (and Adrenaclick is available in the US, including a couple generics).
My take is that the FDA should have some authority to deny market approval for such small improvements if the company refuses to license them to generic manufacturers. The hard part is deciding what constitutes a small improvement.
It will be interesting to see if the FDA comes down on this. On the one hand, they aren't selling anything, yet. On the other, they are making promises about efficacy for the initial users.
I've seen multiple people try to figure out why there is no competition, and some consensus around the fact that while the drug is not patented, the particular delivery device design (or combination of it and the drug) is patented, and due to issues of needing to train people on multiple different delivery devices, there's no room to break into the market with an equivalent that evades the patent concern.
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cf...
I agree it's a good business plan as a solo participant in the market, but as a second or third entrant, probably less so-- depending on IP around the formulation and delivery method. With the number of company with discontinued products in the Orange book, i suspect there is some economic burden.
that said there seems to be therapeptic equivalents available http://www.parsterileproducts.com/products/products/adrenali... so unless there is collusion, or a supply constraint, i'm not sure why the price will stand in the long term.
(also is don't have expertise in this specific disease/drug so my comments could all be wrong).
EDIT: i just realized i put int he IP links for PAR Pharma's product... i'm not sure what mylan's protection is but i have to get to work....)
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