Any "big pharma" can mfgr another "big pharma's" d

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Any "big pharma" can mfgr another "big pharma's" drug, if the 12 years of manufacturing rights, clarified by Ohm, has also run out.

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It would actually be 12 years after first approval or the end of patent rights whichever is longer. The 12 year FDA exclusivity also applies only to biological drugs.

After the 12 years of exclusivity the entire outline for manufacturing must be turned over to any pharma company requesting it. Once that is done the company has to manufacturer it, test it for safety and equal efficacy to the original and then the FDA goes over those results and inspects the manufacturing facilities before FDA approval for the generic. So it's more like 15 to 16 years before you'll see a generic actually hit the market.

Most generics are made by companies that specialize in it and big pharma stays away because of the low profit margins. The manufacture of something like leronlimab is complex enough that a generics company would have to make a quite large initial investment just to get it off the ground. That generics company could also not promote it for any disease where a Cytodyn specific disease patent is still in effect.