[Enginerrrd]

>I'm pretty sure the FDA has never denied a drug use application because it's not patentable and that's just a conspiracy theory used by people pushing bogus treatments.

No, that's not it, that's a very uncharitable interpretation and is unnecessarily dismissive . The real issue is that no one wants to pay for studies to turn off-label uses to on-label uses if there isn't money in it because the process is expensive, and so won't be done when there are better returns on investment.

[tootie]

Apologies for the wrong interpretation, but I'm still skeptical. The generic drug market is huge, this drug in particular is already approved and in wide use for fertility treatment meaning that it's already passed safety trials. Getting approval for a secondary usage would be less costly than starting from scratch and there would likely be a huge market for this. There is absolutely money to be made from anyone who wants to get in this market.

[fnordpiglet]

Unfortunately I’ve been unable to dig up the details and citations but there have been companies that have tried. It isn’t as straight forward as it seems. See my other comment in this thread about one that tried. I even owned their stock for a while hoping it’ll work out but in the end the FDA didn’t want to encourage safer TRT’s. I was floored when I read their justification and my stock went to zero, and it looks like the company is dead now. I wish I could dig it up, the FDA memo on their decision changed my view of medicine forever.