For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
1/9/2025
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patent Validity ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more
11/10/2023
/ Competition ,
Enforcement Actions ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Unfair Competition
This October, the U.S. Food and Drug Administration (FDA) will be celebrating its 40th anniversary of the “Orange Book” as a resource for consumers, health care professionals, drug developers, and Hatch-Waxman litigants. ...more