developing a drug new drug
Started by BAZ
Nothing. They'd just write for the generic with an off-label use.
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make it a new dosage that isn't available
ok maybe I didn't make this clear enough. Drug companies are unaware that a certain drug can be used for an unrelated problem. If a drug company knew and changed say the mode of delivery they would be looking at a drug bringing them in 50-100 million dollars a year. But they have to know the idea first and are not allowed to use just use it since the person who found the drug use signs non-disclosure agreements or basically has the idea patented. It's almost assured that this person would be looking at monetary compensation to share the idea. Again how much money would this person be looking at.
the thanks of posterity?
For some reason, my troll-sensor is beeping.
Anyway, this is a very naive and broad question. Can a use be patented when a composition patent has expired? Certainly. Will it be hard to defend in court? Depends. How much money? Depends on how much effort you have invested in it. If you come and say "I think it can do that because I think so" you will be sent packing. If you have taken it through preclinical studies, there will be more, and the sum increases progressively the further out is the drug. The payment would also be influenced by the market potential of the drug (which is determined through multifactorial analysis).
Anyway, this is a very naive and broad question. Can a use be patented when a composition patent has expired? Certainly. Will it be hard to defend in court? Depends. How much money? Depends on how much effort you have invested in it. If you come and say "I think it can do that because I think so" you will be sent packing. If you have taken it through preclinical studies, there will be more, and the sum increases progressively the further out is the drug. The payment would also be influenced by the market potential of the drug (which is determined through multifactorial analysis).
Trolling??? I have been using sdn forums for several years now and my question is completely legit. Lets say the clinical trials have been conducted and are successful. But due to confidentiality agreements the drug company can't use your research without your permission. It obviously would make sense to sell your idea and research to the drug company. If this drug would net a drug company millions of dollars, I just am trying to figure out how much the person who came up with the drug concept would make by selling their idea and research. I don't know much about the internal workings of a drug company.
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Keep in mind that in order for a drug to gain a new FDA-approved indication, millions of dollars must be spent in research for approval. Proscar and Propecia are examples of a success.
If the person who signed non-disclosure agreements breaks them, they would not make any money because the contract-holder would likely sue and gain any profit.
The potential off label use of any drug is probably already known and being used for that anyway.
If the person who signed non-disclosure agreements breaks them, they would not make any money because the contract-holder would likely sue and gain any profit.
The potential off label use of any drug is probably already known and being used for that anyway.
Usually u would discover a new use for a drug due to an ADVERSE EVENT, which you are required to report anyway...especially if u work like at an institution....the administration will report it. If the event was favorable, which is ur case...it will just be indicated for off-label use.....if unfavorable...it just becomes a contraindication....that's it.
off label use has no patent.....they'll just stick it into pharmacy resources b4 u even say a thing....no dime for u....
off label use has no patent.....they'll just stick it into pharmacy resources b4 u even say a thing....no dime for u....
It not OTC. I'm kind of paranoid about this situation, hence the vagueness of the thread, I apologize. What I do know is once this information is presented to drug companies, they can't act on the knowledge without my permission, hence why I think this could be a profitable venture...
Keep in mind, that for a drug company to evaluate your proposition, they would need A LOT of information. Do you think we just take the word of every small CRO that tells us they have the new miracle cure?
Also, it has to be profitable for a drug company in order for them to develop it. There are plenty of very good and widely known and used off-label uses which will never be FDA-submitted (and thus are of zero use in marketing) because that will not add to the bottom line. You will have to prove that you will add to the bottom line, not just better the humankind. Pharmaceutical companies are not charities.
Finally, how much in profits would your drug bring? Unless it's something that can be FDA-approved quickly and with virtually no expense added, a drug with some measly $100 million in sales isn't going to interest any of the major drug companies, you'd better look for a start-up, or someone whose major product is about to go off patent and their pipeline is dry.
The only examples of molecules that have become money-makers as brand-names after being off patent (not having a patent in the first place) are Thalomid (which is a special case due to all the safety issues that surround it) and Qualaquine (which is again special because it is the only FDA-approved quinine sulfate). It would be impossible to make a profit on any existing product subject to generic competition based on new use alone. The only way to get anything out of it would be a new formulation. A NON-OBVIOUS new formulation (and the standards for this kind of patents have been redefined through a couple of recent rulings). Being an individual (you sound like an individual, anyone with any kind of CRO or something like that behind them wouldn't be asking basic questions like that on a public forum but would know them - or have experts to ask handy), do you have resources to develop a new formulation? I suppose it's possible, but extremely unlikely (though a team effort did produce Zegerid... U of Missouri's attemt to match U of Florida's Gatorade windfall 😀 ).
It would be better for you if it was an OTC. You could just register it with a different name for that specific use and capitalize on brand loyalty. On Rx market, with mandatory generic substitution (and indicaitons not being reflected in PBM software) your proposal is not likely to add a dime to a company's pockets.
So no one is really developing a "new drug" rather you have a knowledge that a generic drug can be used for an indication no one has ever thought of.
I can tell you that no generic company will spend 300 million dollars in research to gain an FDA indication for a generic drug that's readily available.
Once your anecdotal knowledge becomes public... and it will be, other generic companies will simply benefit without having to spend any money.
ex.
We find out that amoxicillin can be used to control seizure disorder... an FDA indication is not necessary...neurologists will simply write for Amox for seizures.
So why should a generic company pay you any money for your knowledge when the drug is off patent and is no longer viable to garner high margin profit.
Sorry, I don't think you'll make any money off of it. Rather you should do what's right for the humanity and let the healthcare world realize what you know by publishing your knowledge. Then perhaps drug companies will hire you to become their expert... maybe.
I can tell you that no generic company will spend 300 million dollars in research to gain an FDA indication for a generic drug that's readily available.
Once your anecdotal knowledge becomes public... and it will be, other generic companies will simply benefit without having to spend any money.
ex.
We find out that amoxicillin can be used to control seizure disorder... an FDA indication is not necessary...neurologists will simply write for Amox for seizures.
So why should a generic company pay you any money for your knowledge when the drug is off patent and is no longer viable to garner high margin profit.
Sorry, I don't think you'll make any money off of it. Rather you should do what's right for the humanity and let the healthcare world realize what you know by publishing your knowledge. Then perhaps drug companies will hire you to become their expert... maybe.
