Who's on first, the story of the generic pipeline...sometimes generic drugs also get a "stay" of time like the big pharma folks, but of course it's only for 6 months or so and not years...so the race begins to be the first...but sometimes second can pay off as well...before the rest of the generic manufacturers jump in the market...called "generic on generic petitioning" to the FDA....BD  image

So it should come as little surprise that after years of being in the crosshairs of citizen petitions filed by brand firms, generic companies are starting to pull the trigger on some petitions themselves.
Some things haven’t changed, though: the targets of petitions are still generic companies and the beneficiaries are still brand firms, since delays always help them.
The most recent example of generic-on-generic petitioning resolved by FDA is Cobalt’s failed attempt to become the only generic of acarbose (Bayer’s diabetes treatment Precose). Cobalt had made regulatory arguments that it deserved 180-day exclusivity and scientific arguments that other ANDAs needed additional tests. FDA rejected them both, and Cobalt has now launched alongside a generic from Roxane.

The IN VIVO Blog


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