Par Pharmaceuticals announced today that it has obtained final approval from the FDA to market generic Zofran. I would expect it to be available very soon, as in within the next few days or so.http://biz.yahoo.com/prnews/061226/nytu027.html?.v=83
Zofran patent expired
At long last, GSK has lost patent protection on this drug. I would expect some decision by the FDA on the final approval for the first generic in the next week or so. The price probably won't drop dramatically for another six months when the first generic producer loses its 180-day exclusivity. Still a bit of good news for people who use this or are thinking about trying it, I think. Merry Christmas.http://www.rxsolutions.com/b/rxnews/rxnews...cle=674&type=19
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I don't know if there is the same lag time between approval and full production with new generics as there is for brand new drugs, but I think some of the same issues may apply.They don't seem to make a major stockpile of the medication prior to the AOK from the FDA so it may be a few weeks between when the document is finalized and when you can get it in the pharmacy. It takes awhile for them to get enough made to get it fully distributed.K.
Wonder how much cheaper the drug will be. Maybe my GI would be more receptive of Zofran for IBS if he knew the cost I incurred from Lotro could be significantly reduced; however, I'm sure it's still very expensive.I know when Xanax XR went generic it didn't lower the price too much at all.
Kathleen,I've looked at medical news sites pretty frequently over the past few years, and I've noticed that generic producers are usually very quick to launch new products, sometimes shipping them on the day of FDA approval. I suppose since the profits are so huge and the timeframe is only six months, there is the incentive for the first generic drugmaker to be ready. I think that that most of the time the company that gets tentative approval first also gets final approval first, so in this case Par Pharma was probably expecting it. You may be right, though. But a few weeks might actually be a conservative estimate, surprisingly enough.Grant,I honestly have no idea how much the price will go down, so I won't even try to guess. Also, I could be mistaken but from following the news on this I think that Par Pharma only has exclusivity for the orally-disintegrating tablets, and that another company (which will probably be Dr. Reddy's) will get it for the regular Zofran tablets. So it's possible that competition between the two formulations will drive the price down some more but probably not enough to fit most people's definition of "cheap," at least not until the end of June when any producer can start making it. I think at least 25 companies have tentative approval for Zofran from the FDA, so the price competition will probably be pretty intense by summer.
Dr. Reddy's announced today that they have received FDA approval for the regular Zofran (ondansetron hydrochloride) tablets.http://www.moneycontrol.com/india/news/pre.../article/258597
From the CEO of Dr. Reddy's: "We are ready to ship the product."http://news.moneycontrol.com/india/news/bu.../article/258617
That's good know. I know with some new drugs that have come on the market we've had a lot of posts where people are frustrated by the lag between approval and when you can actually get the medication.K.
Par launched its generic Zofran today. As J said Dr Reddy's has been cleared to launch its version which will be "launched shortly".
Its good to hear that Ondansetron will be available generic in the USA, A word of warning though:Ondansetron went generic in March 2006 here in the UK. There are only two licensed UK manufacturers but...The MHRA has granted "Marketing authorisation." To about three other EU companies including: Sandoz and Pliva. The cost to the NHS (according to the BNF) is £107 per 30 4mg tabs for Zofran and £97 per 30 4mg tabs for generic Ondansetron.Privately the cost is still £130 for 30 4mg tabs of either branded or generic.I think within the next two years the UK market will be so flooded with generic Ondansetron that the price will cut in half. That's generally how drugs like this go.A major price cut would be needed before the MHRA would accept any further use of Ondansetron on-license other than the existing:. Post-operative nausea. Treating nausea from ChemotherapyDespite its flaws; the NHS means that with a sympathetic consultant gastro: I can get Ondansetron free of charge!!!In fact I'm going to see the consultant who authored one of the major UK clinical trials of Ondansetron in 1996: The Study Though obviously I can't tell you which one, suffice to say my GP is well P***** off cause he turned down my Ondansetron request and tried very hard to stop me getting it.Best Regards,mr_colt
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