Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.
But with those copies raring to go, and approvals due next month, the Japanese drugmaker is making one last-ditch effort to persuade the court.
The stakes are high: Otsuka and its partner, Bristol-Myers Squibb ($BMY), collected $5.5 billion in Abilify sales last year. Apparently resigned to the drug’s fate, Bristol-Myers factored big Abilify sales losses into its 2015 forecast, with companywide sales expected to hit $15 billion, max.
Yes - but if they can delay the generic versions of Abilify - thats an extra $5.5 Billion in their pockets - so obviously a good thing from their perspective. A new drug will take time to ramp up - and when people change medications - they might choose to try a different one, from another company. Or - many people would just stay on the generic version of Abilify and not move on to the new Otsuka medication at a high price.
Legal cases are very slow to move through the courts. And generally the expectation is that they will fail in their attempts - so it won’t be news if they lose the case.
Why are you interested in it? most of these drugs by the companies are just minor tweaks on the existing drug (abilify in this case) to keep some revenue going with a very high price.
They are not much different than the previous generation drug by the same company and are very expensive.
Hey SzAdmin - I think that there are significant differences between Abilify and Brexpiprazole - Brexpiprazole is not as strong of a partial dopamine agonist as Abilify - Also it is not as activating as Abilify and does not cause a lot of anxiety, like Abilify does.
These differences are enough for me to take notice and I will seriously consider trying it, with my doctors approval of course.
It is also pretty easy on the body, unlike Risperdal
That didn’t happen to me. But I couldn’t tolerate it, so I had to come off it, and I’m now off meds. It was mostly anxiety, so if brexpiprazole is like abilify with less/no anxiety, then I’d consider going back on meds. I doubt I’d be here if it wasn’t for abilify as it was the only thing that worked.
So it looks like I posted a couple days too soon. According to a few news sites, Abilify generic was officially approved by the FDA as of the 28th. I called my pharmacy and they said they will start getting generics on the shelf by the end of next month.
Yay, I can finally afford an AP that won’t kill me and actually works (as far as I remember from last time I tried it anyway.) Normally I’m not exactly pro ‘med’, but it’s nice to know there’s something I can fall back on if needed that won’t drop me like a log, make me diabetic or inflate me like a damn monstrous balloon.