Estradiol Valerate - Injectable

[Susan]

The trick is to contract out manufacturing and shipping 100%. All we would do is take orders, money,  and issue shipping orders to the contract manufacturer,  we never actually have to directly touch the product. Money covers all the operating costs, employees and benefits, an operating buffer, and legal/liability fund. Then we sell the product as close to costs as reasonable. I can pretty much guarantee it would be more in line with the generic with the coupon $50, than the name brand price $200+ for the same quality and efficiency.

[Colleen_definitely]

And that's why I do science and not business 

Yes that would be a far better way of doing it.

[TonyaW]

The trick is to contract out manufacturing and shipping 100%. All we would do is take orders, money,  and issue shipping orders to the contract manufacturer,  we never actually have to directly touch the product. Money covers all the operating costs, employees and benefits, an operating buffer, and legal/liability fund. Then we sell the product as close to costs as reasonable. I can pretty much guarantee it would be more in line with the generic with the coupon $50, than the name brand price $200+ for the same quality and efficiency.

It's a prescription drug so you would need a pharmacy to do the distribution.  If you could get 30 or 40% of the market to run through one pharmacy though, you could probably negotiate a pretty good price.






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[SadieBlake]

Let's start with the need for FDA approval to be selling this in the first place. Essentially you're talking about being a compounding pharmacy and a. They're still not all that cheap, b. I and most people would rather deal with something manufactured with quality controls that compounding pharmacies can't do.

And you can't just go out and buy an API for resale. FDA requires records and lot traceability of every manufacturing step. The GMP requirements are huge.

By all means have at it, I just think you're barking up a more complex tree than you realize (with felony violations of the FDA act starting at $10,000 up to $1,000,000).

[TonyaW]

If you are talking about starting a new manufacturing plant, the costs and time frame and FDA regulations would be excessive. Prohibitive if that's all you wanted to make.  You might be able to make it cheaper as a compounded prescription, but there are limits on doing that in quantity.  At some point it would be considered manufacturing.

I think Susan is thinking along the lines of having some one that already makes it making it for her to distribute.  I don't know what permits etc would be required to do that.  You would need to be a pharmacy (or physician) to distribute to patients though.

I'm suggesting working with an existing pharmacy and negotiating a bulk discount from an existing manufacturer. 

None of these things would ease the shortage any time soon though.

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[Kendra]

I'd aim for a deal with Starbucks.  Single tall estradiol, no foam

[AnonyMs]

Another option would be to promote the use of implants in the USA. Many women prefer them, and they are not subject to the whims of large pharmaceutical companies. Make an info pack for transwomen and doctors showing where to source implants, the equipment and techniques necessary to use them, and explain why they are good.

[Jessica Lynne]

My understanding, and correct me if I'm wrong is that part of the issue here is that there's a negligible demand wuth exception to the Trans community. Given the fact that only a small percentage of us use the stuff, where's the market? If it's supply and demand, that's really not much of a market when you consider all the hoops and distribution. Regardless of the profit per unit it may still look like a losing proposition to the manufacturer. I hope not, but this may e the case. If this is happening with EV, I have to suppose the issue will show up with EC soon, as well.

[KayXo]

Another option would be to promote the use of implants in the USA. Many women prefer them, and they are not subject to the whims of large pharmaceutical companies. Make an info pack for transwomen and doctors showing where to source implants, the equipment and techniques necessary to use them, and explain why they are good.

I believe there are quite a few doctors using them already in cis and transwomen in the US.

[AnonyMs]

I believe there are quite a few doctors using them already in cis and transwomen in the US.

Could be a lot more though. It seems to be a small minority.

[Susan]

You are making it more complicated than it is. If we wanted to do this we would get the needed regulatory approvals which can be fast tracked provided we are providing an identical generic to an existing formulation. We don't manufacture it, we simply contract manufacture, packaging, and shipping with fda approved and licensed manufacturers. If we did this we would simply find out out per unit costs, and needed profit margins, then identify and approach the large distributors with a much cheaper product getting them to distribute the product to the distributing pharmacies.

Promotion can simply be a letter mailed to every pharmacy and health insurance company in the United States (at first) letting them know that this identical product is available at a cheaper price. You could also take out advertising in pharmacist trade publications.

As for demand these drugs are used for both Trans and natal women.

[Transfused]

They had me try Estradiol injections a year ago. I felt nauseous and groggy on them. I was also very very sleepy. It was last year somewhere around March.

I feel more calm and balanced on transdermal patches.

Pills and injections have too much spikes and hormonal spikes give me headache and anxiety.

Estradiol patches and Estradiol gel are the only two products that work really really well for me.

[SadieBlake]

You are making it more complicated than it is. If we wanted to do this we would get the needed regulatory approvals which can be fast tracked provided we are providing an identical generic to an existing formulation.

Honestly I've only touched on the simplest complications. I mean by all means do it and prove me wrong. However my 20+ years working I'm the industry might suggest I have some idea of the realities (I've written FDA filings and had my work reviewed and not found wanting during FDA inspections).

Fast track only applies to new investigational approvals specifically for unmet needs combined with life threatening diseases. There are 2 existing suppliers and I sincerely doubt alleviation of dysphoria meets the FDA's idea of life threatening.

Additionally the use of estradiol in any form for gender dysphoria / transition is off-label indication. The existing approvals are all based on safety and efficacy in treating natal females.

I'm not saying it's a bad idea and if I had a source of suitably pure EV and if oral route were workable, I'd just use that.