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Category Archives: Orange book

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Federal Circuit Upholds Decision to Delist System Patent from the Orange Book

ANDA Litigation, Orange book, Paragraph IV, REMSBy Seung Sub KimMarch 9, 2023

Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware granting a motion for an injunction to delist Jazz Pharmaceuticals, Inc.’s (“Jazz”) REMS patent from the Orange Book, as the patent covers neither the drug itself nor a method of using it. Jazz Pharms., Inc., v. Avadel CNS…

FDA Increases Transparency Through Expanded Paragraph IV Patent Certifications List

Orange bookBy Megan ChristnerJuly 3, 2019

On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval.  The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry…

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