3 ms·
I looked into it and I don't find any. It is not patented, and no law forces you to only use the brand Daraprim. If someone created a generic replacement, it w
by codexon 11y ago
I looked into it and I don't find any.
It is not patented, and no law forces you to only use the brand Daraprim. If someone created a generic replacement, it would be on the fast track to be approved like every other generic.
The synthesis method is even listed publicly.
https://pubchem.ncbi.nlm.nih.gov/compound/4993#section=Use-and-Manufacturing https://pubchem.ncbi.nlm.nih.gov/compound/4993#section=Use-a...
The only roadblock to a generic version was because no one wanted to compete with $1/pill.
FDA information:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=008578&TABLE1=OB_Rx http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail....
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=008578&Product_No=001&table1=OB_Rx http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclne...
There are no unexpired patents for this product in the Orange Book Database.
There is no unexpired exclusivity for this product.
- zaroth 11y agoWhat do you think it would it reasonably cost to setup a manufacturing line for pyrimethamine and get approval to sell it as a generic in the US?
- ken47 11y agoLook around the responses for the notion of controlled access to the drug, and the obstacles it imposes on putting out a generic.
- bduerst 11y agoYou keep saying generic. Daraprim is a generic, which has a government instituted monopoly, making it not a subject to free market. Others could go through the process to be Medicare approved, but that doesn't change that it's not subject to a free market.
- codexon 11y agoI don't think you or ken47 have more than a layman's understanding of the subject. Daraprim is a brand name. Pyrimethamine is the active ingredient. When you create a generic, it must be checked that it is roughly equivalent to the approved version. Meaning there are no impurities and you digest the drug about the same rate which is determined mostly by the inactive ingredients. This process is relatively fast, often taking 1 year or less compared to the decades it takes to approve a new drug. And if you are going to be saving medicare millions of dollars, you can bet it is going to be put at the top of their todo list and will probably be tested within days. To say that this is a government monopoly because you can't sell your drug from day 0 without any testing is quite a stretch.
- bduerst 11y agoRight - Exactly. Pharma drugs are granted monopolistic power by the government. Or even duopolistic power. That's exactly what ken47 and I are saying. To say that a market, which is regulated with government-granted monopolistic or duopolistic power, is a free market is quite a stretch.
- codexon 11y agoIt is becoming clear to me that you aren't even bothering to read what I wrote. So this is going to be my last reply. Generics are extremely easy, cheap, and fast to pass approval. Needing a minimal amount of time to check that your drug is roughly equivalent to an existing drug is NOT a monopoly.
- bduerst 11y agoI did read what you wrote: https://news.ycombinator.com/item?id=10255578 https://news.ycombinator.com/item?id=10255578 >I don't see how pharma is not a free market in this case. It's a monopoly because it has government-granted monopolistic power. Generics can go through the approval process and be granted similar power, making a duopoly. That doesn't change the fact that it is a monopoly right now and definitely not a free market. Seems like someone has a case of confirmation bias.