Paul,
The patent for omeprazole the active ingredient doesnt expire until 4/2001, so andrx cannot come out with their own NDA version before then. Also with an NDA filing, the burden is a little more difficult in that they will have to run more comprehensive trials. I look for them to follow up with an NDA version, but not to file for approval for at least another year or two. Filing 3 years early doesnt make as much sense for an NDA.
The plus to filing so early for the ANDA is that not only are they first to file, but by the time the patent expires, the 30 months is expired, so as soon as the patent expires, Andrx should be free and clear, given they hold up their end in the probable litigation. So in short, it makes sense that they filed the ANDA a year or two ahead of a possible NDA given the competitive nature of generics coupled with the time until the initial patents for prilosec expire.
Jim |
