Hatch-Waxman, biosimilars and the patents behind approved drugs.
40 articles · page 4 of 4
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical industry by balancing the interests of brand-name drug manufacturers and generic drug manufacturers. It introduced the…
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. However, the intersection of patents and generic drug approvals can be a complex and challenging…
Written by : Blake A. Winn & Jason J. Jardine The “Orange Book”, more formally known as Approved Drug Products with Therapeutic Equivalence Evaluations, identifies U.S. Food and Drug Administration (FDA) approved drug products as well as any…
Written by : Nima Zargari, Ph.D. On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC , the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s grant of an…
