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FDA explains how paragraph IV certifications and 180-day exclusivity affect priority eligibility
Summary
FDA presenters said ANDAs with paragraph IV certifications may qualify for priority review under specified circumstances tied to 180-day exclusivity status and the number of approved drug products listed in the Orange Book.
Bailey Larson explained that paragraph IV (P4) certifications can make an ANDA eligible for priority review, but eligibility depends on the 180-day exclusivity status and the count of approved products in the Orange Book.
"If your ANDA has a paragraph 4 or p 4 certification, it may be eligible for priority review under this factor," Larson said. She listed three circumstances applicants should document: first applicant where 180-day exclusivity has not been extinguished; a subsequent applicant where 180-day exclusivity is triggered but not expired; and other P4 ANDAs if there are fewer than four approved drug products in the Orange Book (including the RLD).
Larson emphasized that a patent listed in the Orange Book that an ANDA must address via paragraph 3 or paragraph 4 certification still counts as a blocking patent regardless of litigation status and that applicants should use the P4 website to verify 180-day exclusivity information.
