Generic clopidogrel: whiplash for the masses
Saturday morning, we received a voicemail sent to all of the branches in our chain about the stopped production of generic clopidogrel. You may recall that Apotex shipped all of the generic it had on hand as soon as their deal with S-A and BMS fell through. Well a judge has just ordered Apotex to stop producing and shipping the generic, so you can see why Apotex was in a hurry to get everything they had out the door, just in case.
Fortunately, there's not going to be a recall, so Judge Stein certainly made the right decision in that case, but I'm waiting to hear what the shakeout ends up being. Will generic clopidogrel remain on the market or will it disappear? The voicemail made it sound like our company's supplies of the generic will hold for as long as it takes to resolve the matter once and for all, but that could just as well have been in response to Apotex assurances that everything would go swimmingly. The possibility that Apotex might lose wasn't even considered, which I found disingenuous. That's in stark contrast to this WaPo article which makes it sound as though Apotex has no chance of winning at all. (Which very well could mean that it was written from a press release from Sanofi-Aventis, given that there's no stock response information for BMS listed, who also has a huge stake in Plavix's fate.)
Frankly, I don't know what to think. I'm not a lawyer, and I'm not familar with the patent dispute in this particular case. The folks at Patent Baristas don't have much more, either. If the generic disappears, it's going to piss a lot of people off, both patients and providers. Myself included. No one likes being jerked around, particularly when it affects their wallet.
[tags]Medicine, pharmacy, plavix, clopidogrel, Apotex[/tags]
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[...] So it looks like at the end of next week, we're going to run out of generic Plavix. I've not followed the business drama of Big Pharma in a little while because I find it dull, so I have no commentary on the outcome of the lawsuit, which I presume has been settled in S-A and BMS's favor. Apotex had a good run while it lasted. I mentioned in September that we were warned that this might happen. [...]
Pingback by Goodbye, generic Plavix (for real) :: OnThePharm — November 30, 2006 @ 10:53 pm
It looks like generic Plavix is going to be on hold for a while.
Preliminary Injunction Against Apotex Upheld On Appeal
10 Dec 2006
Sanofi-aventis (Paris Bourse: EURONEXT: SAN; and New York: NYSE: SNY) and Bristol-Myers Squibb Company (New York: NYSE: BMY) (the "companies") announced today that the United States Court of Appeals for the Federal Circuit has upheld the August 31, 2006 preliminary injunction issued by the United States District Court for the Southern District of New York. The injunction ordered Apotex to halt its sales of a generic version of clopidogrel bisulfate that competes with PLAVIX® pending the District Court's decision in the trial on the merits. As a result of the decision of the Court of Appeals, the preliminary injunction remains in place.
The companies believe that the Apotex generic product infringes their intellectual property rights, which they continue to vigorously defend in the pending patent litigation. Trial on the merits is currently scheduled to begin on January 22, 2007.
Comment by Douglas Anderson — December 15, 2006 @ 5:27 pm
Yeah I posted about it here.
Comment by RJS — December 15, 2006 @ 6:28 pm
Its really all about money. Never mine the patient who could use
the cheaper generic.
Comment by JimL — July 8, 2007 @ 9:18 pm