This is usually true. The patent is filed before you start clinical trials, because it must be described in publications. Those trials together often take 5 yea

This is usually true. The patent is filed before you start clinical trials, because it must be described in publications. Those trials together often take 5 years or more. Only after that can you even file the New Drug Application or foreign equivalent. Edited to add: Also, people often lump the market exclusivity extensions in with the patent. The FDA offers companies and incentive to try their drugs in children. Without this, almost nothing would be approved for kids because the trials are ridiculously expensive (even compared to adult trials).