3 ms·
You are correct, but in a process that requires submission of the patent to the FDA, you can also request an FDA "new drug product exclusivity."
by akira2501 3y ago
You are correct, but in a process that requires submission of the patent to the FDA, you can also request an FDA "new drug product exclusivity."
- refurb 3y agoNo, 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.