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Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity?

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Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity?

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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.

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