The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA)...more
The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we summarized online here. In the article below, we...more
The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new drug application (ANDA) by...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
8/26/2021
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more
2/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Orange Book ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Packaging ,
Regulatory Agenda