Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity?
Yes, pediatric exclusivity is the only exclusivity that runs from the end of other exclusivity protection (New Drug Product and Orphan Drug) or patent protection. A six-month pediatric exclusivity that attaches after a patent term is not a patent extension; it is a FDA-enforced exclusivity period that begins at the termination of the patent.