July 11, 2008 - 6:45pm
I am wondering if Purdue will be changing OxyContin's formulation due to their admittance of falsifying its abuse potential. That is my first question, but another interesting thing is the UNIQUE timing of this admittance close to the issue of patent infringement with Purdue as a plaintiff. Purdue won and it was stated that they were the only ones allowed to manufacture or produce the drug. This was suspiciously around the same time they disclosed that OxyContin was more highly addictive than they originally disclosed.
I am wondering if this will give them the opportunity to change OxyContin's formulation since they will be the only ones able to make/sell it, and then after time (experimentation with the new formulation) will give up their patent hold on this medicine and then have all the other manufactures replicate the new "formulation"????
hmmmmm, I am wondering if some agency helped grease the wheels for this timing to be so appropriate and sooo coincidental!!!
And if there was an agency not in medicine involved in medicine production...GOD HELP US!!!!
Can anyone guess which one it is?????
Any thoughts????
July 11, 2008 - 11:27pm
#2
you meen
You meen pepper covering???? WTH???
July 12, 2008 - 9:53am
#3
A new formulation would
A new formulation would require a new approval from the FDA which is an expensive and time consuming venture. Since the oxycodone itself is not under patent, it is only the sustained release part of the medication that is covered by the patent. If another drug company came up with a new sustained release method and got it approved by the FDA, they could then market their own (non-generic) sustained release oxycodone and compete with Oxy-contin.
If you are cynical, you might say that when the patent on Oxy-contin expires, Purdue will introduce a new and improved sustained release oxycodone, and inevitably market it as being more abuse resistant than Oxy-contin.
Due to the expanded understanding of genetic variation in the metabolism of the codones/codeines, I think this whole class will experience little growth, and morphines/morphones and synthetic opiods will account for most new narcotic analgesic drug introductions.
July 12, 2008 - 2:11pm
#4
Ok
So then the sustained action of the medication is under patent and that is what was debated then? Opana ER isn't made by Purdue or is it? I read about Opana ER's sustained action. Is it different than OxyContin?
July 12, 2008 - 2:27pm
#5
I believe "Contin" refers to
I believe "Contin" refers to the extended release system used and patented by Purdue. Opana is made by Endo pharma I believe and has a different time release mechanism, although they are probably fairly similar and most ER pills have a 12 hour time release.
Check with a licensed MD before you take any suggestions!
July 12, 2008 - 3:07pm
#6
A
A manufacturing/formulation change doesnt take no where near as long or as much money than it does to get a completely new drug approved. All Purdue would have to do is prove that the new formulation is as effective and within the same tolerances as the old formulation. Basically they would file an abbreviated new drug application instead of a new drug application to they (purdue) wouldnt have to go through phase I,II,III studies.
July 12, 2008 - 6:22pm
#7
See...
You see. Now these were the types of responses I wanted. You guys rule. Check out my newest post entitled "You gotta check this out" I am so angry and I was wondering if someone else can relate to me with this. I live in a MAJOR metropolitan area and its like I am in a small tiny community like someone said in there. It is really pathetic!! I am telling you!!!
July 12, 2008 - 7:27pm
#8
I can....
Most DEFINITLY relate with you Flyer
July 19, 2008 - 5:10pm
#9
ALL DOCTORS READ
I have read the previous posts and I thought I would include this link for you. This confirms what I suspected!!! Please copy and paste!!!
July 19, 2008 - 5:13pm
#10
I have to say this again:
If you do a patent search you will see that Purdue has several patents for different types of abuse resistant extended release oxycodone. I think one even involved capsaicin as a deterant for insufalation (sp?). Also if you havent heard of Remoxy, you might want to google it. They recently submited there new drug application. However all things aside, your post is hard for my brain to process tonight and maybe I will re-read it tomorrow.