The Food and Drug Administration is enhancing the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on branded drugs.
Mallinckrodt has suspended the spin-off of its specialty generics business, but it is still considering several options for splitting off the business, according to a recent Bloomberg report.
Under the settlement, Par will market its generic Auryxia beginning on March 20, 2025, excepting certain circumstances that would lead to an earlier launch.