What's next for Seroquel?
AstraZeneca, the makers of Nexium and Seroquel, are hoping to expand the reach of their number 2 drug, Seroquel. With approval by the FDA pending, AZ is looking to get the medication approved to treat bipolar depression as well as bipolar mania, which would give it a marketing edge over its closest rivals, Risperdal and Zyprexa. Doctors can already use Seroquel in any way they see fit, even if it is not approved, but gaining this approval will give AZ the ability to market the drug more heavily, to a wider potential patient base. (As an example of a non-approved use for Seroquel, some doctors give it to patients taking stimulants for ADHD so they can sleep at night.)
The other stuff in the article is non-news. Mostly fluff surrounding this one nugget of information. The lawsuit by Teva isn't anything new, nor is it particularly noteworthy. Any generic manufacturer that is able to get their generic drug to market first has a six-month monopoly on all prescriptions filled for that generic. Teva is simply doing their due diligence; if on the extremely off-chance that they win, they will have six months of uninterrupted, competition-free time in which to make most of their money on that particular generic drug. I will cover the Hatch-Waxman Act of 1984 which created this oddly anti-capitalist situation sometime in the near future. Rarely are patents broken by such lawsuits, but the risk is worth taking every time because even one successful patent-break will result in billions for the generic manufacturer who is first to market.
[tags]AstraZeneca, Teva, patent lawsuits, generic drugs, Seroquel, quetiapine, atypical antipsychotics[/tags]
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[...] In my last post about Seroquel's future, I mentioned the Hatch-Waxman Act (PDF), which was passed in 1984. The Act was supposed to speed up the adoption of generic drugs when the patents behind name-brand drugs ran out. This happened at first, but as pharmacy has expanded, the Act has created a bottleneck at the FDA. It is speculated that the bottleneck is Big Pharma itself: creative lobbying seems to have resulted in a reduction in the budget for the Office of Generic Drugs — which in turn has limited its capacity to approve generic drugs to some 400 per year. [...]
Pingback by On The Pharm » 800 drug patents backlogged at the FDA — May 11, 2006 @ 9:55 pm
[...] 5. Atypical antipsychotics fall in the same gray area that the tri-cyclic antidepressants do. They aren't well understood, and new uses for them are being found all the time. Yesterday I mentioned Seroquel, and I said that it was sometimes used to help those taking stimulants to combat ADHD. Well it is, and Risperdal and other similar medications are used in novel ways as well. [...]
Pingback by On The Pharm » Medicine intersects with bad journalism and off-label drug usage — May 12, 2006 @ 9:41 pm
[...] Nothing like a little fear-mongering to make a mountain out of a molehill. Forest has had its patent on Lexapro challenged by Teva in court, in an effort to open it up to generic competition sooner. This practice is pretty common because the windfall from even a single successful patent-challenge could be huge for the company with the 6-month monopoly on generic sales. In the case of a successful patent-challenge, Big Pharma probably wouldn't have had time to cut a deal with a generic drugmaker to create a competing "authorized" generic, which means true market exclusivity for at least a few of those six months. [...]
Pingback by Nerves “frayed” at Forest? Um… why? :: OnThePharm — July 13, 2006 @ 4:47 pm