News & Analysis as of

Federal Trade Commission (FTC) FDA Approval Patent Litigation

McDermott Will & Emery

FTC Revives Orange Book Listing Challenges

On May 21, 2025, the Federal Trade Commission (FTC) issued its third round of warning letters – and its first under the Trump administration – against pharmaceutical manufacturers for allegedly improper listing of patents in...more

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

4 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide