ct barrister question

Xifaxin is the brand name of rifaximin. There is no generic version of xifaxin available in the US.

"No generic formulation is available in the US and none will appear while the FDA approval process is ongoing. If Xifaxan receives full FDA approval for hepatic encephalopathy it is likely that Salix will maintain marketing exclusivity and be protected from generic formulations until March 24, 2017."

http://en.wikipedia.org/wiki/Rifaximin

HI CT PLEASE CHECK OUT THE THREAD I WROTE ON DR. SIEBECKER WHO SAID THE GENERIC RIFAXIMIN DOES NOT HAVE THE SAME PROPERTIES AS THE BRANDED..SURE SHE WAS TALKING ABOUT IN U.S.A IN THE STUDY HMMMM

It's fraud, or a foreign study. There is no generic xifaxin that is legally sold in the USA. Salix has the only patent on it. I read that some online pharmacies are selling a counterfeit drug which is fraudulent and illegal. It's like buying street drugs, BUYER BEWARE. Just because someone tells you a drug is something does not mean it should be believed.

There is generic xifaxin but not in the USA.

It's possible that the US study really did use generic rifaximin is the US. Just as clinical trials can use pharmaceeuticals prior to any approval at all, they can also use ones that have been approved only in other jurisdictions.

I'm not asserting that's what happened here, just that research studies aren't bound by commercial availability.

PERHAPS SCOTT IS CORRECT I AM THINKING IT WAS DONE HERE IN U.S.A. BUT NOT SURE WHY DR. SIEBECKER WOULD BOTHER TO PUT OUT THIS INFO IF IT DID NOT APPLY TO U.S.A.

AND CT YOU ARE CORRECT IN WHAT YOU Sid in u.s.a only branded given..to bad thought i might have figured out why xifaxin is a dude for me!!maybe the 550 twice a day is not enough..anyone tie more? thanks scott and ct..

That is correct. A study does not have to involve drugs that are available for prescription. Actually, they often are not. This is where manufacturers get their data to present to the FDA.

However, Rebebcca, could you please provide a link to this study you are talking about? I looked at all the studies listed inder the tab "studies" on the SIBO website you mentioned http://www.siboinfo.com/dr-siebeckers-bio.html, but I could not find it. I did not see it mentioned in the blog either.

But generally, the way that generics get approved is that they have to prove that they are essentially the same in regard to the intended treatment effect, as the brand name. Sometimes there are individual indiosyncracies or intolerances that make one form better than another. But, it is not a blanket rule.

Jan

jan i will try to find it..

One of the interesting problems for generic rifaximin is that the way it works might conflict a bit with how the FDA assesses equivalence. The FDA likes when generics have similar "bioavailability." That (roughly) means that about the same amount of medication gets into the blood at about the same rate. However, rifaximin mostly stays in the gut - its low bioavailability is a benefit for its particular labeled and unlabeled uses, but it might just give the FDA fits.

generic xifaxin does exist because i gave allykat a number to call in u.s that gets drugs for us from other countries and it was coming from india .she found out it was generic and affordable..but not brand

i still pay and kept my drug coverage from our original health coverage because i am on medicare otherwise..i got xifaxin and i must have good drug coverage because i do not recall it being expensive for my payment which was issue for allykat..

by the way just as an aside going on medicare isn`t cheap for everyone..i pay far more for insurance through medicare than i paid on private insurance in our working days !!!! i suppose i should be grateful they consider my my retirement income worthy of paying three times the average payment...i guess i am rich by their standards!!!!!..haha

I do not doubt that generic xifaxin can be purchased online from foreign sources, but is that transaction legal once those drugs are shipped into the USA? And is it advisable to be getting drugs online from an unknown foreign source?

Just an FYI regarding ways to keep Xifaxin costs down. It's MUCH cheaper to get the 550mg tabs than the 200mg. The retail price on 60? 200mg was like $1800 or something. With my insurance, it's $10 for a supply of the 500mg, but was $60 if I ordered the 200mg. Also, ask your GI for samples. He gave me about 20 boxes worth last time I went (that's 40 pills I think).

yep..maybe thats why i did not think xifaxin so expensive..i got the 550 mg. which is what was suggested by my doc..

You can get generic xifaxan from India A 90 day supply for about 130.00. It is manufactured by Sun Pharmaracutics. India is the only country that is except from genetic patents. I called Rebbe's Pharmacy in Florida. I have not spoken yet to my doctor about this but it does make me a little nervous getting it overseas but the difference in price for me is like $5000. I'm first trying to go thru patient asst to see if I Qualifly.

Costco quoted me $1500 for 60 pills, 550mg, a 1 month supply. I'm on Medicare, and with my new wonderful expensive aarp medical RX plan it only covers a third so basically I'm now paying $475 a month till I reach my deductible of $5000. They dropped my last plan, don't even get me started, and I was only paying $75.