News Focus
News Focus
icon url

DewDiligence

09/08/16 10:02 AM

#204171 RE: masterlongevity #204170

3-year H-W exclusivity for a new indication can be applied only once for a given drug.

For a drug that lacks 5-year H-W exclusivity for an NCE, the 3-year H-W exclusivity can be applied to the first FDA-approved indication.