JD Supra

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray

The Federal Trade Commission (FTC), supported by the Food and Drug Administration (FDA), issued a policy statement on September 14 indicating that the FTC intends to “scrutinize improper Orange Book ...
JD Supra

Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product ...
IPWatchdog

FDA Issues Request for Comments on Modernizing Patent Listings in the Orange Book

“For many, there’s been a frustration about how to answer the form’s questions, which may have been written by an FDA expert and not a patent attorney. I think it helps everyone to modernize the ...
MedCity News

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

AbbVie, AstraZeneca, and GSK are among the 10 companies now under scrutiny by the Federal Trade Commission, which is cracking down on businesses it says improperly or inaccurately placed items on a ...
Morningstar

SCIENTURE announces FDA Orange Book Patent Listing for ArbliTM, (losartanpotassium) Oral Suspension, 10mg/mL.

TAMPA, FL, May 19, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to ...
The National Law Review

Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...