On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
1/27/2025
/ Compliance ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Shortages ,
Trade Secrets
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
1/15/2025
/ Biologics ,
Chevron Deference ,
Chevron v NRDC ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
SCOTUS ,
Summary Judgment ,
Supply Shortages
On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more
12/20/2024
/ Distributors ,
Drug Compounding ,
False Advertising ,
FDA Approval ,
FDA Warning Letters ,
Knockoffs ,
Labeling ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Violations
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
11/4/2024
/ Administrative Procedure Act ,
DQSA ,
Drug Compounding ,
Enforcement ,
False Advertising ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Lanham Act ,
Medical Devices ,
Monopolization ,
Patents ,
Popular ,
Proposed Rules ,
Regulatory Agenda ,
Supply Chain ,
Supply Shortages ,
Unfair Competition ,
Weight-Loss Products
The Corporate Transparency Act became law in the United States on January 1, 2021 and required compliance beginning on January 1, 2024. For more information about the background of the statute, please read our prior articles...more
2/7/2024
/ Anti-Money Laundering ,
Beneficial Owner ,
Compliance ,
Corporate Transparency Act ,
Filing Deadlines ,
FinCEN ,
Ownership Interest ,
Penalties ,
Regulatory Agenda ,
Regulatory Requirements ,
Reporting Requirements ,
Shell Corporations