1. What the 505(b)(2) Pathway Actually Is (and What It Isn’t) The 505(b)(2) New Drug Application (NDA) is a hybrid […]

A technical deep dive for pharma IP teams, portfolio managers, R&D leads, and institutional investors Why Most Generic Drug Strategies

What Branded Generics Actually Are — and Why the Definition Matters for IP Teams The pharmaceutical industry uses ‘branded generic’

Drug repurposing has a dirty secret. For every sildenafil-to-Viagra success story, there are dozens of ventures that got five years

Patent cliffs get all the attention. Divisional patents do the real work. When a blockbuster drug faces loss of exclusivity,

The full playbook of drug patent lifecycle management — and what it costs everyone else Drug companies spend roughly $2.23

1. The 20-Year Myth: Why Nominal Term Is the Wrong Starting Number Ask most people in the pharmaceutical business how

Every dollar a brand-name manufacturer recovers in the market traces back, in some way, to the strength and duration of

Executive Summary Patent Term Extension (PTE) under 35 U.S.C. § 156 is one of the most financially consequential and systematically