Articles tagged with “fda-orange-book”

How Generics Challenge Patents: A Hatch-Waxman Act Guide

An educational guide to generic drug patent challenges. Learn about the Hatch-Waxman Act, the ANDA pathway, Paragraph IV certifications, and the FDA Orange Book

30 min read

1/7/2026

hatch-waxman act paragraph iv certification generic drugs anda pathway fda orange book patent litigation pharmaceutical regulation patent linkage

Drug Patents Expiring in 2026: A Comprehensive Guide

An educational analysis of the 2026 drug patent cliff. View a complete list of patent expirations, including Ozempic & Januvia, and their impact on generic drug

25 min read

11/15/2025

patent expiration patent cliff 2026 generic drugs biosimilars pharmaceutical industry fda orange book ozempic patent januvia patent