You cannot always obtain a generic version; sometimes not even the original version.
Drug manufacturers regularly take approved medicines, which are off-patent and non-exclusive, due to safety reasons (side-effects, risks to patients) or due to commercial reasons: high cost of production, low demand, or possibly to increase demand for an exclusive alternative.
There are also perverse incentives at play and it often isn't easy to get a generic approved, especially if the original drug was already removed from market, under biosimilar regulations:
> Drug manufacturers regularly take approved medicines, which are off-patent and non-exclusive, due to safety reasons (side-effects, risks to patients) or due to commercial reasons: high cost of production, low demand, or possibly to increase demand for an exclusive alternative.
One of the big reasons is the cost of regulatory approval. Most drugs are cheap to make per-unit but if you're only going to sell to a few thousand patients, the fixed cost of regulatory approval means nobody does it at all, and then the patient has to buy a patented drug that costs a lot more.
Lower the cost of making generics and more people will do it.
>Drug manufacturers regularly take approved medicines, which are off-patent and non-exclusive, due to safety reasons (side-effects, risks to patients) or due to commercial reasons: high cost of production
Sounds like the new drug is providing value, contrary to what the parent poster is claiming.
> or possibly to increase demand for an exclusive alternative.
Aren't generics typically produced by a manufacturer other than the original manufacturer? Sure, the original manufacturer might have a generics division to compete with generics, but if they're the sole provider there's no reason to offer a generic to undercut their brand-name variant. This theory makes no sense.
When a drug first stops being protected by a patent, in order for another company to begin making a generic version, they have to pay some up-front costs (of course).
If the government requirements for starting a generic for it are particularly stringent, it seems like these up-front costs might be particularly high?
I feel like there may be a strategy stealing argument that might apply here?
If it would be profitable for another company to pay the upfront costs to produce a new generic, then it seems like the company that is already producing the drug could undercut them, by producing the same drug as they are already making. (perhaps under a different brand name as they were already doing?)
This seems like it would discourage other companies from trying, as there might be a significant chance they don’t recoup their up-front cost?
If the company with the patent releases a new improved version of the drug, which is under a new patent, it seems like they could potentially phase the old one out of production, getting people on to the new one? If they didn’t need to lower the price of the old one due to no generic being produced, then even if the improvements are marginal, it might not be hard to get people to switch to the improved-and-still-under-patent version (just by telling people it is an improvement and that old version might not be available soon).
If they then stop producing the old version, then a company that makes generics could then make a generic without worrying about being undercut by the original company, but if people are switched to the improved version, will they notice that there is a generic of the version they used to take, and, if so, will they trust it? Maybe? I don’t know. Maybe they would. (Oh, especially if the out-of-pocket price is the same, due to insurance, they might be less inclined to try switching to it..)
If it is unclear whether people would switch to it, then the company considering making the generic has a significant wager to make. Would they make it?
Maybe they would. Maybe the chain of events I described falls apart at some point. I don’t think it is obvious that it does, but it seems reasonably likely that this chain I described doesn’t work and isn’t a real phenomenon. But I don’t think it obviously doesn’t work.
One of the big reasons is the cost of regulatory approval. Most drugs are cheap to make per-unit but if you're only going to sell to a few thousand patients, the fixed cost of regulatory approval means nobody does it at all, and then the patient has to buy a patented drug that costs a lot more.
Lower the cost of making generics and more people will do it.