Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more
3/27/2025
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks ,
Weight-Loss Products
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
2/17/2025
/ Drug Compounding ,
Final Rules ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
We were so pleased to have the opportunity to address InformaMarkets’ 13th Annual Pharma IPR Conference in Mumbai on legal challenges to polymorph patents. Patents covering one or more crystalline forms of a drug substance at...more
As Benjamin Franklin famously remarked, “nothing is certain except death and taxes.” Recently, the U.S. Court of Appeals for the Third Circuit provided more certainty about the latter by holding that legal expenses incurred...more