On: If you have first-hand knowledge of the FDA’s torp...

[rocqua]

How is the FDA responsible for patent issuance? Isn't that the remit of the US Patent Office?

[akira2501 → rocqua]

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 → akira2501]

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.