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FDA: pediatric exclusivity extends exclusivity but not the patent; labeling carve-outs end when patent expires
Summary
Strandberg explained that pediatric exclusivity adds six months to certain exclusivities but does not extend a patent, so Section 8 labeling carve-outs tied to a patent end when the patent expires and labeling must be revised to add back protected information.
Heather Strandberg summarized the agency's position on pediatric exclusivity: it is "a 6 month extension of the period during which the approval of an ANDA may not be made effective," and is treated as an extension of exclusivity rather than as a patent extension. "The period is added to the end of certain listed patents and exclusivities, but there's an important difference between the two," she said.
As a result, Strandberg said an applicant that submitted a Section 8 statement to omit patent-protected information must revise ANDA labeling to add back the omitted information once the patent expires, even if a pediatric-exclusivity period remains. She used a hypothetical with a patent expiring 04/01/2026 and pediatric exclusivity through 10/01/2026 to illustrate that a Section 8 statement does not extend through pediatric exclusivity.
