Megan Chacon

Dec 18, 2023 | jdsupra.com | Megan Chacon |Madelyn McCormick

The Hatch-Waxman Act allows a generic drugmaker to rely on a branded drugmaker’s Food and Drug Administration-approved New Drug Application if the generic drugmaker can show that the generic drug has the same active ingredient and is bioequivalent to the branded drug. Generally, a generic drug label must copy the branded drug label. But there are some exceptions. A generic drugmaker may propose a label that attempts to “carve out” a patented use. See Caraco Pharm. Lab’ys, Ltd. v.

Jun 2, 2023 | iam-media.com | Geoffrey Biegler |Megan Chacon

Hatch-Waxman trends in 2022 and key developments in US patent litigation Register for limited access Register to receive our newsletter and gain limited access to subscriber content. Register now Subscribe to unlock unlimited access Get news, unique commentary, expert analysis and essential resources from the IAM experts. Subscribe now Already have access?