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The Marshall Protocol Study Site > PROF. MARSHALL'S PERSPECTIVE > Prof. Marshall's Perspective > Sankyo's patent on Olmesartan Medoxomil runs until Oct 2016


Sankyo's patent on Olmesartan Medoxomil runs until Oct 2016
 Moderated by: Prof Trevor Marshall Page:    1  2  3  Next Page Last Page  
 

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Prof Trevor Marshall
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 Posted: Tue Apr 26th, 2011 14:08

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Well, I am busy at the DNA-day conference in China, but I wanted to share with you some text from our FDA application for the NDP (new drug product) Pure Olmesartan:
"To the best of our knowledge and belief, the US patent on Pure Olmesartan, CAS: 144689‑24‑7, expired on April 25th, 2011.

The US patent on Olmesartan Medoxomil is listed in the FDA Orange Book as expiring on October 25th, 2016, with NPP exclusivity expiring on Aug 14, 2013"
There are also a number of ways Sankyo could seek to extend Olmesartan Medoxomil's patent and marketing exclusivities beyond even 2016.

Sometime in the future, after we get FDA approval for Pure Olmesartan, today will mark an important step in the evolution of the MP into mainstream medicine...

..Trevor..


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 Posted: Tue Apr 26th, 2011 15:22

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CONGRATULATIONS to Dr. Marshall and the entire ARF staff.

I hear strains of Beethoven's 9th symphony singing for all of us. Hallelujah,  HALLELUJAH, HALLELUJAH.

Sherry



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D25, Total: 12 measured 11/3/15 Started MP=01/04/05 Diagnosis: Sarc 12/04; "cat scratch disease" or necrotizing graunulomas 10/88; Raynaud's (diagnosed 1980?)
k
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 Posted: Tue Apr 26th, 2011 15:35

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Congratulations to all involved. Well done and THANK YOU for all your hard work.

regards, k



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CFS menorrhagia & dysmenorrhoea anxiety depression paxil 600mg calcium daily Ph1.Oct07 Ph2.Feb08 Ph3.Sept08 BeniOnly.Aug09 MinoRestart.Dec09 25D=50(Jul07)23(Oct07)13.2(Jan08)12.8(Oct08)10(Sept09)12.8(Jun10)12.4(May11)8.3(Apr12) 4.4(Jun13) <4(Nov14)
ChrisMavo
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 Posted: Wed Apr 27th, 2011 01:41

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Congratulations to all involved!  :D

I look forward to the pure olmesartan study commencing soon!!

And I DID have an extra hot chocolate today .... spiked with some Irish Whiskey to celebrate this big date for the MP!!  :D



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Pipistrelle
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 Posted: Wed Apr 27th, 2011 01:52

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Mmmm, I will have a wee celebration too, and raise my glass of sparkling mineral water (! all I have in the house atm) to Dr Marshall and the Team - and all of us!

The future is bright and in the meantime we have our NoIRs and OM!

Morag :cool:

Last edited on Wed Apr 27th, 2011 01:53 by Pipistrelle



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Limburg
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 Posted: Wed Apr 27th, 2011 13:12

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Excellent work, Dr Marshall and staff!

Congratulations and good luck with the study!



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MP Jan.2009.Break from september 2017-december 2017. MS.1997. AIH 2004. Muscles, Joints, Skin, various symptoms. 25D=25.6(nmol/ml)september 2014.From april 2016; blood and protein in urine. Skinrashes, several allergies.
Daki
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 Posted: Thu Apr 28th, 2011 01:22

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Good news for MP. I have also joy.

Congratulations.:)
 


Exuce me, maybe this is not accurate place for one question, but:

I am not sure, whether olmesartan medoximil or pure olmesartan is better for MP treatment.
Noted, if good remember it, that olmesartan medoximil have got about one small windows more than pure olmesartan.

Gratefull for clear explain as for laic.
Daki
 

Last edited on Thu Apr 28th, 2011 05:25 by Daki



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lyme boreliosis since 2002 + allergy,1-abx since sep.09,2-abx since dec.09,3-abx since apr.11,2-abx since jul.12,0-abx since mar.13, 25D=26 XI.06-09, 25D=20 II.12-10, 25D=11 VI.28-10, 25D=8 I.14-11, 25D=8.76 X.19-11, 25D=3 IV.24-13.
Lottis
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 Posted: Thu Apr 28th, 2011 03:51

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:D:D:D25th of April 2011:D:D:D


A day to remember! :cool:



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cbay
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 Posted: Thu Apr 28th, 2011 06:16

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Does this mean no one can patent the PO again and it is wide open for ARF uses? I am rusty on patent laws...



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Prof Trevor Marshall
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 Posted: Thu Apr 28th, 2011 16:52

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The main thing IMO is that manufacturers can freely manufacture the product. Patents now mainly cover its use (like my own patent applications for th1 disease). Up until now Sankyo's lawyers have 'persuaded' a number of manufacturers here in China not to make OM by threatening patent infringement.

In China, both patents (OM and PO) have now expired, as far as I can tell... Chinese intellectual property law is complex...
 

ChrisMavo
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 Posted: Thu Apr 28th, 2011 16:58

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How does this impact the start of the FDA pure olmesartan study ... if at all?  As you know I am anxious to get that going. 



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PLS/ALS, speech difficulty, dizziness, leg weakness, overly emotional, Ph1Aug2609,11/2012 25D-12, 11/11: 25D-10, 04/11: 25D-11, 07/10: 25D-13, 05/10: 25D-15, 11/09: 25D-20, 9/09: 25D-27, 7/09: 25D-38, 1,25D-46, Mod Ph2Oct09, 100mg Mino
samaa
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 Posted: Sun May 1st, 2011 13:23

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I would like to know what is the differant between Olmesartan Medoxomil and pure Olmesartan



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cbay
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 Posted: Sun May 1st, 2011 13:42

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My simple understanding is the Medoxomil side chain that exists in OM (Benicar) is not there in pure Olmesartan.



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MP July'10 | OCD`94, GERD`03, IBS`04, ADHD`05, Depression`07, Anxiety `10 | 125D45 June10 | 25D25 Sept14 | My Progress
Prof Trevor Marshall
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 Posted: Sun May 1st, 2011 15:56

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Sankyo put the medoxomil radical on Olmesartan in order to slow its absorption, so it could be dosed once a day. That is not what we need for the MP, we want it to go to work as quickly as possible. They also said that Pure Olmesartan was not absorbed as well as Olmesartan medoxomil, but that turned out to be because the flora in a Mouse gut converted most of the Olmesartan to Olmesartan Glucuronide. When we tested in Homo sapiens, that was not so much a problem, and the Pure Olmesartan is more effective at both immune activation, and palliation, when used as we do in the MP :)
 

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 Posted: Sun May 1st, 2011 16:53

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So is the advantage of pure olmesartan over olmesartan medoxomil just one of greater absorption and more consistent absorption, or is it more than that?  Could one simply increase their frequency and/or dosage of olmesartan medoxomil in order to achieve the same effect as switching to pure olmesartan?



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Prof Trevor Marshall
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 Posted: Sun May 1st, 2011 17:13

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Oral Pure Olmesartan reaches its peak concentration at about one hour, and it therefore achieves a higher level peak than achievable with OM, as that absorbs more slowly. A high peak is the best way to bump ligands out of any receptors... It is also the best way to get palliation soon after you feel you need it, eg, when you have forgotten a dose...

There seems to be a limit on OM absorption, and it varies from person to person. An enzyme from Pseudomonas, or its homologue, is necessary for converting OM to O+M, and this may not be present in unlimited quantities in everybody's gut. the PO is just absorbed through the intestine wall intact (a little is degraded to Olmesartan Glucuronide with both OM and PO).
 
You cannot adjust the dosing and/or frequency of OM and achieve what PO can do...
 

leroybrown
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 Posted: Mon May 2nd, 2011 06:03

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Do you know if that would mean you could take less PO than you would OM? And would the PO have less of some side effects like dizziness?

Sounds interesting.

Deb



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And I don't know when - Kate Bush
Aplastic anemia Apr/10, PRCA Jan/09, Agranulocytosis 1991
25D = 25 1,25D = 58 Aug 18/09|25D<4.8 Mar/10|10.8 Nov/12
Sep '09 q8h Nov '09 q6h
scooker48
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 Posted: Mon May 2nd, 2011 07:26

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I am so keen to try the PO.

Yes, I will be patient.

Sherry



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D25, Total: 12 measured 11/3/15 Started MP=01/04/05 Diagnosis: Sarc 12/04; "cat scratch disease" or necrotizing graunulomas 10/88; Raynaud's (diagnosed 1980?)
mvanwink5
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 Posted: Mon May 2nd, 2011 07:35

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Leroybrown,
PO is expected to work at 50% of OM dosage, or 20 mg PO instead of 40 mg OM. Dizziness is IP and not a side effect of olmesartan, who can say what IP a person will experience during treatment?



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leroybrown
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 Posted: Mon May 2nd, 2011 08:04

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That's great about the dosage reduction. The reason I mentioned dizziness was it seemed like olmecip produced less than OM, from what I read, certain people seemed to have an easier time with it.

Deb



____________________
I just know that something good is going to happen
And I don't know when - Kate Bush
Aplastic anemia Apr/10, PRCA Jan/09, Agranulocytosis 1991
25D = 25 1,25D = 58 Aug 18/09|25D<4.8 Mar/10|10.8 Nov/12
Sep '09 q8h Nov '09 q6h

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