No, the patent has nothing to do with it. "New drug exclusivity" is an FDA regulation separate from patents. Basically you get a minimum of 5 year exclusivity

No, the patent has nothing to do with it. "New drug exclusivity" is an FDA regulation separate from patents. Basically you get a minimum of 5 year exclusivity for new molecular entities, and you can add on another couple years if it's a rare disease. Even generic drugs get 6 months exclusivity.