Susan's Place Transgender Resources

Community Conversation => Transitioning => Hormone replacement therapy => Topic started by: Raina Selone on November 27, 2017, 11:55:39 AM

Title: Estradiol Valerate - Injectable
Post by: Raina Selone on November 27, 2017, 11:55:39 AM
Has anyone been able to get injectable estrogen from any of the larger pharmacies (i.e. CVS, Walgreens, Walmart, et cetera)? I would soooo much prefer to get injections than pills but my pharmacy doesn't carry the injectable.

Also, do I have to buy my own sterile needles? Or are they included? How does the purchasing of the stuff work? I feel so unprepared! I just got back from my first endo appointment today and they gave me the pills, but said if I could find someplace that could fill an injectable order, they'd be happy to switch me over.
Title: Re: Estradiol Valerate - Injectable
Post by: TinaVane on November 27, 2017, 11:57:56 AM
Quote from: Raina Selone on November 27, 2017, 11:55:39 AM
Has anyone been able to get injectable estrogen from any of the larger pharmacies (i.e. CVS, Walgreens, Walmart, et cetera)? I would soooo much prefer to get injections than pills but my pharmacy doesn't carry the injectable.

Also, do I have to buy my own sterile needles? Or are they included? How does the purchasing of the stuff work? I feel so unprepared! I just got back from my first endo appointment today and they gave me the pills, but said if I could find someplace that could fill an injectable order, they'd be happy to switch me over.
Does not carry them or out of stock and/or its a shortage where they can't special order it (->-bleeped-<- said 20mg is on backorder , the rest no )


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Title: Re: Estradiol Valerate - Injectable
Post by: JillianC on November 27, 2017, 02:01:17 PM
My Walgreens is able to special order it for me.  You have to purchase syringes separately, the ones I have gotten were the syringe with the draw needle attached and a separate smaller needle for injection.  don't forget alcohol wipes.
Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on November 27, 2017, 04:06:27 PM
CVS had to order it for me and mostly due to stupidity on the part of my insurance coverage it took a week for them to get it in (should have been just a couple of days). However that was just the first one and refills have been straightforward.  On my prior plan the doc sourced it thru a specialty pharmacy that always has it in the shelf. Honestly that was easier for me but that pharmacy is all the way across town so CVS is the LCD.

Needles and syringes will be a separate prescription and you will need to change the needle from one suitable for extracting the med from the vial (19-21 ga would be typical) to a smaller gauge suitable for intramuscular or subcutaneous injection. *** You will want a nurse to train you in how to do the whole thing ***

Going by prescription that cost me more than the drug itself (10 needles, 10 syringes each a $10 copay). So now I order in bulk from an online medical supply. 100 of both ran me $31 at allegro medical and I've seen other women give similar numbers for product + shipping from other places.
Title: Re: Estradiol Valerate - Injectable
Post by: jill610 on November 27, 2017, 04:14:28 PM
My local CVS is showing back order with no ETA. Caremark mail order was able to get it to me but at double the in store cost which seems really backwards for the same 5ml vial.

Syringes and needles are separate.  Cost me $11 for 26 of each (I'm Bi-Weekly for now, going to weekly at half the dose), completely out of pocket. Alcohol swabs I got on amazon for like $8 for 400 or something like that. Pharmacy was much much higher.

Don't forget to get something to put the used needles in.


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Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on November 27, 2017, 07:55:07 PM
Go to goodrx.com and put your drug requirement in. It will bring up the places that have orcan order the drugs in your area with prices. Presently, I get mine from Hy-Vee but it can be had at any number of places. Be prepared. 5 ml of valerate is generally about 45 dollars in 20 mg. Strengthes and 70 dollars in 40 mg. Strengths. I use cypionate and 5 ml. Is 105 dollars. Both are certainly more pricey than pills. If you have no problems with tolerating pills and get your levels where your endo wants, it is without a doubt the most economical route. Good luck!
Title: Re: Estradiol Valerate - Injectable
Post by: Pisces228 on November 28, 2017, 06:08:32 AM
I'm a pharmacy technician at one of the big three pharmacies in America.  Injectable generic estradiol is available in generic only and you have to buy syringes separate. 
Title: Re: Estradiol Valerate - Injectable
Post by: KarynMcD on November 28, 2017, 12:49:47 PM
Quote from: jill610 on November 27, 2017, 04:14:28 PM
My local CVS is showing back order with no ETA.

I'm having problems getting it from Walgreens.
On backorder for over a month.
Title: Re: Estradiol Valerate - Injectable
Post by: Kendra on November 28, 2017, 01:17:55 PM
My endocrinologist knows I work in the software industry, maybe that's why I'm on a patch.  :P

Raina, thank you for joining Susan's and for posting.  As your first post I'll add information we provide to new members.  When you get a chance, would be great if you could introduce yourself in the introductions forum (https://www.susans.org/forums/index.php/board,8.0.html) - we would all like to meet you!

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All the best,

Kendra
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on November 28, 2017, 01:42:26 PM
Quote from: Raina Selone on November 27, 2017, 11:55:39 AM
Has anyone been able to get injectable estrogen from any of the larger pharmacies (i.e. CVS, Walgreens, Walmart, et cetera)? I would soooo much prefer to get injections than pills but my pharmacy doesn't carry the injectable.

Also, do I have to buy my own sterile needles? Or are they included? How does the purchasing of the stuff work? I feel so unprepared! I just got back from my first endo appointment today and they gave me the pills, but said if I could find someplace that could fill an injectable order, they'd be happy to switch me over.

The needles are cheap around 25 cents each. Make sure you buy a sharps container as well, you should be able to buy one at your local pharmacy.
Title: Re: Estradiol Valerate - Injectable
Post by: Pisces228 on November 28, 2017, 09:08:56 PM
Quote from: KarynMcD on November 28, 2017, 12:49:47 PM
I'm having problems getting it from Walgreens.
On backorder for over a month.

hmm that's odd.  I checked the vendor website at my no-name big pharmacy chain I work at before my drs appointment in November and it said it was available (ended up sticking with pills anyway).  Perhaps it was depleted since it is still a somewhat limited supply.
Title: Re: Estradiol Valerate - Injectable
Post by: Pisces228 on November 28, 2017, 09:10:30 PM
Quote from: Susan on November 28, 2017, 01:42:26 PM
The needles are cheap around 25 cents each. Make sure you buy a sharps container as well, you should be able to buy one at your local pharmacy.

Just remember you can't return the full container back to the pharmacy for disposal.  You usually mail it off in the box it came in.
Title: Re: Estradiol Valerate - Injectable
Post by: Raina Selone on November 29, 2017, 06:16:45 AM
Quote from: Kendra on November 28, 2017, 01:17:55 PM
My endocrinologist knows I work in the software industry, maybe that's why I'm on a patch.  :P

Raina, thank you for joining Susan's and for posting.  As your first post I'll add information we provide to new members.  When you get a chance, would be great if you could introduce yourself in the introductions forum (https://www.susans.org/forums/index.php/board,8.0.html) - we would all like to meet you!

Things that you should read




Site Terms of Service & Rules to Live By (https://www.susans.org/forums/index.php/topic,2.0.html)


Standard Terms & Definitions (https://www.susans.org/forums/index.php/topic,54369.0.htm)

Post Ranks
(including when you can upload an avatar)

(https://www.susans.org/forums/index.php/topic,114.0.html.)
Reputation rules (https://www.susans.org/forums/index.php/topic,18960.0.html)
Cautionary Note (https://www.susans.org/forums/index.php/topic,82221.0.html)
Photo, avatars, & signature images policy (https://www.susans.org/forums/index.php/topic,59974.msg383866.html#msg383866)

All the best,

Kendra

OK, your joke made me laugh. That was a nice one, but a bit too much for a byte. ;)
Title: Re: Estradiol Valerate - Injectable
Post by: LexiDreamer on November 29, 2017, 08:23:17 AM
So I called my local Rite Aid and generic Estradiol Valerate is indeed on backorder. They said the brand name is available though.
I called my primary and they said it's very hard to get insurance to pay for brand name meds. But their own pharmacy says the generic will be available mid December.
I have enough doses to get me to the end of December, bit I hope they're right about it being in stock again soon. I don't like the idea of cutting it this close.

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Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on November 29, 2017, 08:36:55 AM
Quote from: LexiDreamer on November 29, 2017, 08:23:17 AM
So I called my local Rite Aid and generic Estradiol Valerate is indeed on backorder. They said the brand name is available though.
I called my primary and they said it's very hard to get insurance to pay for brand name meds. But their own pharmacy says the generic will be available mid December.
I have enough doses to get me to the end of December, bit I hope they're right about it being in stock again soon. I don't like the idea of cutting it this close.

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So weird. Delestrogen is ridiculously expensive from the manufacturer. I wonder where these shortages are originating from?
Title: Re: Estradiol Valerate - Injectable
Post by: LexiDreamer on November 29, 2017, 09:03:49 AM
Honestly, I really think it's a result of so many Transwomen coming out and starting HRT.
Both my therapist and my primary have indicated that the number of transgender folks contacting them has skyrocketed.
I think (in the US at least), people are just becoming more comfortable with it and it has a positive feedback effect.
The more trans folk that are "out" and being noticed, the more the closet trans folk realize it's ok to come out.

I don't think the pharmaceutical companies ever anticipated the demand for a somewhat niche drug increasing as fast as it is.

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Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on November 29, 2017, 10:07:01 AM
The prior shortage, about a year ago was due to a manufacturing problem with the producer of the castor oil that it's diluted in and it affected both brand name delestrogen and the Perrigo generic because they both sourced the oil from the same supplier.

As far as I know there are no problems with 40mg/ml concentration, however the more widely used 20mg concentration is in shortage. FDA has no reason for shortage posted right now.
Title: Re: Estradiol Valerate - Injectable
Post by: KarynMcD on November 29, 2017, 10:11:26 AM
I have a feeling that a component part might be manufactured in Puerto Rico and with the devastation from the hurricanes this year they might not be making a lot of it.

Title: Re: Estradiol Valerate - Injectable
Post by: mako9802 on November 29, 2017, 04:47:30 PM
Just placed an order on 11/29/2017 from Walgreens...delayed...1 day and counting.....
Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on November 29, 2017, 05:15:14 PM
Quote from: SadieBlake on November 29, 2017, 10:07:01 AM
The prior shortage, about a year ago was due to a manufacturing problem with the producer of the castor oil that it's diluted in and it affected both brand name delestrogen and the Perrigo generic because they both sourced the oil from the same supplier.

As far as I know there are no problems with 40mg/ml concentration, however the more widely used 20mg concentration is in shortage. FDA has no reason for shortage posted right now.

Yes. I've found no indication of lack regarding the 40 mg. solution. Fortunately, I'm using depo and have found no problems in the supply line. I'm sure it will iron out and if Lexi is correct in her assertions then it should rectify itself in short order. Let's be frank, there's no shortage of wild yams, so this has to be either unanticipated demand with the manufacturer unaware, or something else is at play. Given the present politics, a wild guess could take you down any number of rabbit holes.
Title: Re: Estradiol Valerate - Injectable
Post by: Angela49 on November 30, 2017, 09:50:06 AM
I live in New England and it took 2 weeks to fill my 20mg script at CVS.
Just picked it up today. :)
Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on November 30, 2017, 04:49:50 PM
Quote from: Angela49 on November 30, 2017, 09:50:06 AM
I live in New England and it took 2 weeks to fill my 20mg script at CVS.
Just picked it up today. :)

Well if this thread serves no other purpose, I suppose it's a heads up to lay in supplies so you don't find yourself hung out to dry.
Title: Re: Estradiol Valerate - Injectable
Post by: LexiDreamer on December 06, 2017, 12:34:48 PM
I just messaged my Primary and now they're saying it's not available. :(
I'll check with my pharmacy again and if they can't get it, I'm gonna have to see if my insurance will authorize the brand name version.

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Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on December 06, 2017, 04:18:50 PM
Quote from: LexiDreamer on December 06, 2017, 12:34:48 PM
I just messaged my Primary and now they're saying it's not available. :(
I'll check with my pharmacy again and if they can't get it, I'm gonna have to see if my insurance will authorize the brand name version.

Sent from my SAMSUNG-SM-N910A using Tapatalk

the brand name is ridiculously priced. And by ridiculously, I mean 4 times the cost. See if your Dr. will switch you to cypionate. So far I've had zero issues with availability. Also, try these folks and see if they cant fill your present prescription:

Civic Center Pharmacy
https://www.civiccenterpharmacy.com/contact.html
Address. 7331 E. Osborn Drive Suite 208. Scottsdale, AZ 85251. Phone / Fax. 480-945-9519 Phone 480-945-9854 Fax 480-949-6033 Fax
Title: Re: Estradiol Valerate - Injectable
Post by: antia212 on December 06, 2017, 06:25:04 PM
My insurance only covers injectable estradiol valerate through a mail order pharmacy called Accredo/Express Scripts. It's 100% covered as part of my medical benefits. They send a 3-month supply at a time  and it comes with syringes/alcohol pads. They can mail it to your PCP or to your home.

It's a pretty sweet deal and I'm grateful that my insurance covers it completely, BUT it was actually quite a headache to finally get the order shipped. My insurance would tell me I needed approval from the mail order pharmacy and the mail order pharmacy would tell me I needed approval from my insurance, so I went back and forth many times explaining that the other had redirected me their way. At the end of the day, it was my insurance that was making the process difficult. I actually didn't need need an approval from anyone! A kind woman named Stephanie at the mail order pharmacy noticed how upset this was making me and called my insurance on my behalf and took it up to escalation. That was four weeks after going back and forth and spending over 20 hours on the phone. It was humiliating and I kept getting misgendered. I've always had a feminine voice and would get called mam at the beginning of a call, I'd say my legal name and the person would excuse themselves and call me sir, and then after I told them I was trans, they would awkwardly excuse themselves AGAIN and call me mam.

I often wondered if i should just have stuck with the pills, and I'm a week into my first shot now and don't know how worth it it's going to be, to be honest. I am happy that I'm finally on estrogen though :)

If possible, try calling your pharmacy and ask if they have a mail order pharmacy that they work. Ask about the cost and if an approval from your PCP would be necessary. It may take a while, but at least you'll be on pills in the meantime.


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Title: Re: Estradiol Valerate - Injectable
Post by: antia212 on December 06, 2017, 06:27:31 PM
try calling your insurance and ask if they have a mail order pharmacy that they work with***

sorry, was typing on my phone! :)


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Title: Re: Estradiol Valerate - Injectable
Post by: KarynMcD on December 08, 2017, 07:07:58 AM
Saw my doctor the other day. We switched to the 40mg strength. It came in the next day.
Title: Re: Estradiol Valerate - Injectable
Post by: LexiDreamer on December 08, 2017, 05:21:26 PM
Quote from: LexiDreamer on December 06, 2017, 12:34:48 PM
I just messaged my Primary and now they're saying it's not available. :(
I'll check with my pharmacy again and if they can't get it, I'm gonna have to see if my insurance will authorize the brand name version.

Sent from my SAMSUNG-SM-N910A using Tapatalk
I contacted my Primary and they called it into my regular pharmacy (Rite Aid). I got a text message from my pharmacy yesterday stating it was out of stock. So I called the pharmacy to inquire about the 40mg vial's availability.
They told me that they ordered my regular (20mg) and that it would be ready the next day.
I went to pick it up and the pharmacist informed me that the generic was in shortage due to "production issues" so they ordered the brand name Delestrogen.
I asked about my insurance and they told me my insurance covered it and my copay was the same!
Phew! Calamity averted!

I hope my sisters on here have similar luck in getting their EV prescriptions filled.

I must say, aside from loathing the cold weather, I'm very fortunate to live in the great state of New York.


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Title: Re: Estradiol Valerate - Injectable
Post by: mako9802 on December 11, 2017, 08:59:31 PM
Doc just changed my script after the 20mg/ml was in shortage.  Now  the 40mg/ml vial is delayad as well.  I just can't not win for losing.
Title: Re: Estradiol Valerate - Injectable
Post by: LexiDreamer on December 28, 2017, 09:53:19 AM
Has anyone filled their EV script lately?

Just wondering what the status of the shortage is.
Title: Re: Estradiol Valerate - Injectable
Post by: AshleyP on December 28, 2017, 06:38:22 PM
Quote from: LexiDreamer on December 28, 2017, 09:53:19 AM
Has anyone filled their EV script lately? Just wondering what the status of the shortage is.

I just got my prescription and turned it in to the pharmacy yesterday. They had it filled today. The script is for the 40mg/mL concentration.

I used the GoodRX website for their discount coupon, and it noted that there's been shortages for both the 20mg and 40mg versions.  I did see a website that claimed the shortage has been resolved, but I don't remember the site.

I'll add that the packaging said the product was manufactured for Perrigo by PharmaForce, Hilliard, OH.

--AshleyP
Title: Re: Estradiol Valerate - Injectable
Post by: Barb99 on December 29, 2017, 04:16:42 PM
I normally use the 20mg/ml. Went to get it refilled 10 days ago and was told by Walgreen's and CVS that the generic supplier is no longer making it and none is available. the My doctor wrote me a new prescription for the 40mg/ml which was in stock at both places.

The brand name was available in both concentrations (at 7 times the cost). This is in the Chicago area.
Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on December 29, 2017, 04:31:13 PM
I filled mine about 3 weeks ago, I'll let y'all know when it comes up next week whether I get it ok. Perrigo 40mg/ml.
Title: Re: Estradiol Valerate - Injectable
Post by: Shadowsister on December 29, 2017, 08:43:28 PM
I was just switched to injections from pills but was able to thankfully get the injectable estrogen. I am really worried about these shortages though. I wonder how long they'll last. I'm in big trouble without my estrogen.
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on February 28, 2018, 11:34:27 AM
From the company making the generic which is totally unavailable as far as I can determine (name brand is available but at over 3x the price)

From the email I sent to them.

Quote
I am contacting you for more information about the shortage of your generic Estradiol Valerate product. Please provide as much detail as you are able about the cause of this shortage, what precipitated it, what the solution entails, when the product will be available on the market again, as well as any steps Perrigo is putting in place to prevent a recurrence the shortage in the future.


Perrigo's official response...

QuoteSusan,

Thank you for reaching out.  We do not have a comment to provide at this time, thanks.


-Brad

Bradley Joseph
VP, Global Investor Relations and Corporate Communications
Perrigo Company plc

20mg/ml 5ml vial (Name Brand) $200 monthly supply. ($198 with GoodRX Coupon at Walmart)
20mg/ml 5ml vial (Generic) $120 monthly supply ($48 with GoodRX coupon at Walmart)
Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on February 28, 2018, 12:22:15 PM
Susan, I noted in another recent thread, may as well add it here ...

I spoke with customer service at Perrigo a couple of weeks ago when my local CVS said they couldn't source it. the response was that it had gone into backorder. I think they also said there was no particular manufacturing problem and in any case I knew there wasn't anything FDA reportable because I'd already checked the FDA website.

The cs rep also advised me that the backorder problem had started late January/early February and that it was expected to be back into normal supply by mid March.

Having worked in corporate medical / pharma for over 20 years I can assure you at least nobody I've ever worked for would answer questions about the details you requested.
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on February 28, 2018, 01:58:52 PM
Quote from: SadieBlake on February 28, 2018, 12:22:15 PM
Susan, I noted in another recent thread, may as well add it here ...

I spoke with customer service at Perrigo a couple of weeks ago when my local CVS said they couldn't source it. the response was that it had gone into backorder. I think they also said there was no particular manufacturing problem and in any case I knew there wasn't anything FDA reportable because I'd already checked the FDA website.

The cs rep also advised me that the backorder problem had started late January/early February and that it was expected to be back into normal supply by mid March.

Having worked in corporate medical / pharma for over 20 years I can assure you at least nobody I've ever worked for would answer questions about the details you requested.

The company that manufactures it for Perrigo states long term backorder, and referred all questions back to Perrigo. I am half tempted to start a funding campaign to create a low cost alternative supplier of the medication.

Each 20mg/5ml vial has 100mg of Estradiol Valerate  ($10,388.00 per kg which is 1,000,000mg)
1,120mg of Benzyl Benzoate (200 LT for $6383.85)
100mg of Benzyl Alcohol (200 LT for  $6235.70)
and the rest is made up of Caster Oil (200LT for $2516.80, 200,000 ML)

I would estimate their actual costs per vial is under $2 Add in manufacturing and packaging and we are still probably less than $5.00-$20.00. Yet it is being sold for $120-$220 per vial... This is obscene.

All of these ingredient prices are USP/medical grade from FDA approved manufacturers.

So the raw materials are not that expensive.

Manufacturing would have to be negotiated but you can get FDA Certified companies to handle the manufacture and packaging. Approval is the question mark, but if you keep the formulation identical then it should be manageable.
Title: Re: Estradiol Valerate - Injectable
Post by: Devlyn on February 28, 2018, 02:06:45 PM
I see the parts cost, but the manufacturing expenses and liability are where the real money kicks in.
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on February 28, 2018, 02:39:29 PM
QuoteUnavoidably unsafe products

Some prescription drugs are considered "unavoidably unsafe" products. This means that no matter how well or carefully they are manufactured, they can never be made 100 percent safe. For example, these drugs may come with potentially harmful side effects, but are still prescribed because of their overall benefit to the user. If drugs in this category are found to have been manufactured properly and carry appropriate safety warnings then they cannot typically be used in a successful products liability lawsuit.

Unknown/known side effects

While drug manufacturers have a duty to warn about known side effects, they are not obligated to warn about unknown side effects or dangers. There is no duty to warn about possible reactions in unusually vulnerable users either but the fact that a possible known reaction is rare does not absolve the manufacturer of its duty to warn nor does it mean the patient experiencing the reaction is unusually vulnerable. Manufacturers typically work to eliminate their legal liability for the duty to warn by providing all relevant information to the patient's prescribing physician or to the pharmacist. Manufacturers are expected to stay on top of new studies or information about their products and take reasonable steps to update medical professionals on newly discovered side effects or possible adverse reactions.
Title: Re: Estradiol Valerate - Injectable
Post by: Colleen_definitely on February 28, 2018, 08:23:38 PM
Quote from: Devlyn Marie on February 28, 2018, 02:06:45 PM
I see the parts cost, but the manufacturing expenses and liability are where the real money kicks in.

Yep, the machinery is not cheap.  Then you have record keeping, quality control, shipping, etc...

Could you do a small scale startup for under a mil?  I'm sure you could, staffing could be kept relatively low by using automation, but you better believe I'd want a full NMR and LC-MS workup on every single batch of EV and other materials coming in and going out.  The instrumental analysis could likely be farmed out and cut costs further, but I am not 100% sure where the FDA stands on that.
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on February 28, 2018, 09:06:01 PM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: Colleen_definitely on February 28, 2018, 09:10:55 PM
And that's why I do science and not business  ;D

Yes that would be a far better way of doing it.
Title: Re: Estradiol Valerate - Injectable
Post by: TonyaW on February 28, 2018, 09:57:16 PM
Quote from: Susan on February 28, 2018, 09:06:01 PM
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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Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on February 28, 2018, 10:02:07 PM
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).
Title: Re: Estradiol Valerate - Injectable
Post by: TonyaW on March 01, 2018, 12:44:43 AM
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.

Sent from my SM-G930V using Tapatalk

Title: Re: Estradiol Valerate - Injectable
Post by: Kendra on March 01, 2018, 01:05:16 AM
I'd aim for a deal with Starbucks.  Single tall estradiol, no foam
Title: Re: Estradiol Valerate - Injectable
Post by: AnonyMs on March 01, 2018, 05:19:40 AM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: Jessica Lynne on March 01, 2018, 08:25:16 AM
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. :(
Title: Re: Estradiol Valerate - Injectable
Post by: KayXo on March 01, 2018, 09:19:01 AM
Quote from: AnonyMs on March 01, 2018, 05:19:40 AM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: AnonyMs on March 01, 2018, 09:52:26 AM
Quote from: KayXo on March 01, 2018, 09:19:01 AM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: Susan on March 01, 2018, 03:57:46 PM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: Transfused on March 01, 2018, 04:01:00 PM
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.
Title: Re: Estradiol Valerate - Injectable
Post by: SadieBlake on March 02, 2018, 01:53:36 AM
Quote from: Susan on March 01, 2018, 03:57:46 PM
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.