Granted, it's not going to be easy because the original patent has expired so it's going to be very easy for an upstart Indian company to conduct basic clinical trials, use part of the data of the second patent's holder to prove equivalency (they did this test so we don't need to do this test), and then get approved through an accelerated pathway in the FDA. Which is why even well-capitalized players will shy away from what could be a cash cow.