In response to the yesterday's article - Shopping for Generic Imitrex - Teri Robert, who needs no introduction around here, posted the following:
"According to the FDA web site, there are NO final approvals of generic Imitrex; only tentative approvals."
She is right, there seem to be much confusion about availability of generic Imitrex (sumatriptan succinate), and for a good reason.
FDA so far granted the right to produce generic Imitrex pills for the US market only to one company - Dr. Reddy's Laboratories. The company is not in a good financial state and might not be able to fill the demand of the US market for sumatriptan tablets.
Imitrex should get more of the complete "generic" status sometimes next year, 6 to 9 month from now when some other companies would join the party.
However, the whole shift of Imitrex to generics has been mured with lots of lawsuits and back-door dealings, it seems. GlaxoSmithKline is not really eager to loose control of it's best moneymaker.
They even went as far as introducing Treximet (produced together with Pozen) - a simple combination of Imitrex and Naproxen. They hope that replacing Imitrex with Treximet will allow them to keep charging the 90% premiums on the product that so many big pharmaceutical companies claim they need to survive.
On the other hand, pharmaceutical companies that specialize in producing generic versions of drugs have other ideas. For example:
"Drug company Pozen said Tuesday that it’s received a second generic challenge to its migraine drug, Treximet.
Chapel Hill-based Pozen (Nasdaq: POZN) said in a filing with the Securities and Exchange Commission that generic drugmaker Mylan Laboratories (NYSE: MYL) is challenging the patent on Treximet. Generics maker Par Pharmaceuticals (NYSE: PRX) also has filed a challenge against Treximet.
The challenge from Mylan Laboratories is in the form of an application to the FDA to sell a generic copy of Treximet. The application contains what’s known as a “paragraph IV certification.” In essence, that’s a generic drug company’s way of saying either that the patent on a branded drug is invalid or that a generic form of the medicine would not violate the patent."
Mylan Laboratories and Par Pharmaceuticals, who already made a similar move on Treximet, do have a point. Combining two generic drugs is not exactly developing something new but simply repackaging.
In a situation like this, whoever gets better lawyers, wins. In the meantime, my gentle readers, lets hope that at least generic Imitrex will get to our pharmacies soon. Then, if we so desire, we'll be able to roll our own generic Treximet as well.
link: Pozen gets second Treximet challenge
Wednesday
Generic Treximet Might be a Possibility Soon
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8 comments:
The amount of inaccuracy in this article is STUNNING. Do some homework - Dr. Reddy's financial situation is extremely solid, and this Exclusive AG of Imitrex will only help.
PS: http://www.drugstorenews.com/dr_reddy.html
I do agree it will help. I do not know if that alone would pay for all the renovations they invested in recently. And the "Exclusive" is going to last only for what - 6 or 9 month or so? Might not be enough time to capitalize on the investment. Unless the price of Dr. Reddy's generic Imitrex is only slightly lower than the GSC's price. In which case people might not even switch.
Don't worry, I am not putting down Dr. Reddy & Co. I am actually rutting for them - if they can deliver Imitrex at a reasonable price while maintaining the quality, more power to them.
PS: There's no need to post as Anonymous here; put your real tags on. There's no retribution of any sorts for disagreeing with our opinions. Better yet, we welcome it. Just would be nice to know who we are talking to.
Cheers,
Rain
The exclusivity period is six months, or has been. I would have to go back and re-read some articles I looked up while waiting with baited breath for generic Imitrex (I may go months without a migraine then months with daily migraines--and I have to do decide if I have a $30 headache each time). Anyway, I believe it was Mylan that sued GSK and the FDA(?) over the six month rule as being unfair to everyone and the court agreed. I think that the law was changed in very recent years. Looking at the advertisement for the generic Imitrex, they are white triangular pills and there is an 866 number in North Carolina to call. If it weren't for my present headache, I think I would remember more accurately what all the articles said. The good news is that Imitrex officially goes off patent on February 6, 2009, and I don't think there is anything GSK can do about their baby. In the meantime, I might look up Par pharmaceuticals and see if my insurance will let me inject the generic--the method I initially started with. Par is a good company for one of my other generics and I pray they don't drop that product from their line or I'm dead. They make the best generic drug for that on the market (I've had a few brands now) and Par wins hands down. Almost forgot--Mylan has had plans to produce the generic Imitrex tablets on February 6, the patent expiration date, since sometime in 2006, when they got their initial FDA approval. So, there may be more competition for this drug sooner than you think. And don't expect the drug companies to pre-announce their exact plans, since they don't work that way. Sorry this is so long, but this subject is so near and dear to my head.
I looked up the information at Par pharmaceuticals and they are shipping the injectible Imitrex now (I think they are loading up the pipeline) and have been doing so since November 6--a month at this point. It will go on the market early 2009. I'm going to have my doctor write me a prescription that I can have filled as soon as they allow. I already give myself shots for other things, and this will be one more until the tablets are released.
Sure takes them a while. It doesn't take that long to get all that GImitrex to the pharmacies; if the production lines are in place...
White triangular pills, nice. Thanks for the info. I guess we waited this long, we can wait a couple of month more. Wonder what the price would be...
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