The Problem Nobody Admits Out Loud Every large pharmaceutical company has the same conversation at some point. A blockbuster drug […]

A comparative analysis of the statutory stay periods that define when generic and biosimilar manufacturers can enter the world’s two

The most effective weapon in the European pharmaceutical patent arsenal is not the primary compound patent. It is the administrative

Strategic and Regulatory Pathways for Launching High-Value Complex Generics The standard generic drug business is a race to the bottom.

A practical guide for regulatory affairs teams, IP counsel, and C-suite decision-makers The Stakes of the First Submission Every year,

The Gap Between Patent Data and Supply Chain Decisions Every procurement director at a hospital system, every formulary manager at

The Decision That Determines Your Revenue Ceiling Somewhere between completing a Phase II study and walking into an FDA pre-NDA

The Moment the Monopoly Ends On November 30, 2011, Lipitor lost its U.S. patent protection. Within 90 days, the price

The Problem With Waiting Every year, branded pharmaceutical companies watch billions in revenue walk out the door, and generic manufacturers