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[Hurdity]

Update about Elleste products produced by Mylan.  I hope I'm not duplicating stuff that's already been posted as I don't have time to read most of the posts! This information was sent to health professionals and publicised on another site and I have been given permission to reproduce:

"We have received an update on HRT products produced by MYLAN - Elleste Solo 1mg and 2mg, Elleste Duet 1mg and 2mg, Elleste Duet Conti 2mg- Earlier this year MYLAN informed Health Care Professionals that their third party manufacturing partner was experiencing an interruption in the production of the above products. At that time they anticipated a temporary interruption which would be resolved by mid 2019. To ensure the stable supply of Elleste oral tablets in the future MYLAN will be transferring the production of Elleste to a MYLAN owned and operated facility. This transfer is in progress and they anticipate production to resume by the second half of 2020. In the meantime any stock of Elleste oral tablets in the market is available to order and prescribe by your HCP. Once that has supply has been depleted they will not be replenished until the site transfer process has been completed. This does NOT affect the transdermal patches Elleste Solo MX 40mcg and 80mcg"


Hurdity  x

[bear]

Thank you, Hurdity.

What the heck is going to happen by mid 2020? Janssen's Evorel will be available mid 2020, Theramex's FemSeven will be available mid 2020 and now Mylan's Elleste? Is is possible that all these products have a common denominator? A new patent?

Coincidentally...

Fem7 in Germany was being manufactured by Mylan GMBH for Teva and subsequently for Theramex Ireland https://www.docmorris.de/fem7-50-g-transdermale-pflaster/07525728

Mylan's transdermal patch patent has recently expired https://patents.google.com/patent/US5948433A/en.

That's why Teva has decided to stop manufacturing FemSeven patches. When Theramex decided to reformulate them, it was too late, Mylan wasn't interested (patent expiration) and Lohmann LTS wasn't interested (patent expiration, see my post on the FemSeven discontinuation thread).

The glue issues may be genuine (although I'm puzzled that the estradiol only patches are still being marketed), but it's not the whole picture.

BeaR.

[Hurdity]

Well at least hopefully Besins products will still be available - unless the rush for gel creates a shortage there...

Hurdity x

[KiltedCupid]

Thank you, Hurdity.

What the heck is going to happen by mid 2020? Janssen's Evorel will be available mid 2020, Theramex's FemSeven will be available mid 2020 and now Mylan's Elleste? Is is possible that all these products have a common denominator? A new patent?

Coincidentally...

Fem7 in Germany was being manufactured by Mylan GMBH for Teva and subsequently for Theramex Ireland https://www.docmorris.de/fem7-50-g-transdermale-pflaster/07525728

Mylan's transdermal patch patent has recently expired https://patents.google.com/patent/US5948433A/en.

That's why Teva has decided to stop manufacturing FemSeven patches. When Theramex decided to reformulate them, it was too late, Mylan wasn't interested (patent expiration) and Lohmann LTS wasn't interested (patent expiration, see my post on the FemSeven discontinuation thread).

The glue issues may be genuine (although I'm puzzled that the estradiol only patches are still being marketed), but it's not the whole picture.

BeaR.

Thanks for that BeaR - I remember reading something, somewhere recently that said fem7 would be available early 2020. Just have to wait, I suppose...

[bear]

You're welcome KiltedCupid.

Latest update on FemSeven products:

https://www.theramex.com/wp-content/uploads/2019/09/FemSeven-Conti-and-FemSeven-Sequi-Transdermal-HRT-Adhesive-Patched-Stock-Update-1.pdf

BeaR.

[bear]

Provera on the shortage list https://www.sps.nhs.uk/category/shortages-discontinuations-and-expiries/shortages/

BeaR.

[Hurdity]

At this point I don't think anyone should be unduly concerned about this bear. The link (from that particular pharmacy) actually says this:

"Pfizer, the sole supplier of Provera tablets, are experiencing manufacturing delays, and are out of stock of the 100mg tablets until week ending 8th November 2019 and there are insufficient amounts of other strengths to bridge the gap in supply.  At present it seems possible to import supplies of unlicensed medroxyprogesterone acetate 100mg tablets."

So - firstly there is a generic MPA available and secondly this high dose is not used for HRT but as a treatment for other conditions - the dose for HRT is 2.5 mg or 5 mg.

Hurdity x

[Butterfly22]

I got estraderm patches online recently no problem. I bought the 100's as it's better value to chop them up to 25's.

Hi can you point me in the direction to get these please xx

[bear]

At this point I don't think anyone should be unduly concerned about this bear. The link (from that particular pharmacy) actually says this:

"Pfizer, the sole supplier of Provera tablets, are experiencing manufacturing delays, and are out of stock of the 100mg tablets until week ending 8th November 2019 and there are insufficient amounts of other strengths to bridge the gap in supply.  At present it seems possible to import supplies of unlicensed medroxyprogesterone acetate 100mg tablets."

So - firstly there is a generic MPA available and secondly this high dose is not used for HRT but as a treatment for other conditions - the dose for HRT is 2.5 mg or 5 mg.

Hurdity x

Hi Hurdity,

This is just for information. Same manufacturer, same API (active pharmaceutical ingredient), shortages in Australia and Canada, get my drift?

BeaR.

[bear]

Update about Elleste products produced by Mylan.  I hope I'm not duplicating stuff that's already been posted as I don't have time to read most of the posts! This information was sent to health professionals and publicised on another site and I have been given permission to reproduce:

"We have received an update on HRT products produced by MYLAN - Elleste Solo 1mg and 2mg, Elleste Duet 1mg and 2mg, Elleste Duet Conti 2mg- Earlier this year MYLAN informed Health Care Professionals that their third party manufacturing partner was experiencing an interruption in the production of the above products. At that time they anticipated a temporary interruption which would be resolved by mid 2019. To ensure the stable supply of Elleste oral tablets in the future MYLAN will be transferring the production of Elleste to a MYLAN owned and operated facility. This transfer is in progress and they anticipate production to resume by the second half of 2020. In the meantime any stock of Elleste oral tablets in the market is available to order and prescribe by your HCP. Once that has supply has been depleted they will not be replenished until the site transfer process has been completed. This does NOT affect the transdermal patches Elleste Solo MX 40mcg and 80mcg"


Hurdity  x

When was this memo issued? It's not consistent with this info https://www.mims.co.uk/drug-shortages-live-tracker/article/1581516

BeaR.

[shrosphirelass]

I was just looking at the Independent pharmacy and they are showing evorel sequi and evorel conti in stock, for now!

[Hurdity]

I got estraderm patches online recently no problem. I bought the 100's as it's better value to chop them up to 25's.

Hi can you point me in the direction to get these please xx

I was given them by my local dispensary at my GP practice as the only oestrogen only patches available (to them) ie in stock at their distributor. I expect other brands are available to order?

Hurdity x

[Hurdity]

When was this memo issued? It's not consistent with this info https://www.mims.co.uk/drug-shortages-live-tracker/article/1581516

BeaR.

I can't access your link but it came to my attention via a private online group on 16th September and was info sent to health professionals. I'm just reporting it verbatim for info (with permission).

Hurdity x

[bear]

If that refers to Mylan's latest info for HCP displayed at their MyWay HRT Hub, it's from August, according to my Gynae. Apparently their must have run out of stock in 3 weeks.

BeaR.

[Hurdity]

I have no idea bear - just reporting on the info as it reaches me by whatever means because that is what women on here are wanting to know.

Hurdity x