Pediatric Exclusivity News Today

Ad hoc announcement pursuant to Art. 53 LR U.S. District Court for the District of Delaware ruled the Entresto (sacubitril / valsartan) ‘combination patent’ to be invalid Novartis will appeal to the U.S. Court of Appeals for the Federal Circuit to reverse the District Court’s rulingNo generic Entresto product has received FDA approval as of todayPending a final appeal decision and other ongoing litigation involving multiple patents, any launch once generics receive FDA appro...

Imposing the FDA on-label/off-label framework on administratively defined "children" resulted in a regulatory demand for pediatric studies that had no basis in clinical medicine, with the exception of the small group of preterm newborns.

On May 17, the U.S. Food & Drug Administration ("FDA") issued two important draft guidance documents, which clarify the agency's approach to requirements and incentives in the realm of pediatric drug development...

On December 27, 2022, Haug Partners LLP and Gibbons PC obtained a key victory as to all counts for its client, plaintiffs Takeda Pharmaceutical Co. Ltd. and Takeda Pharmaceuticals...