Articles tagged with “generic-drugs”

2027 Drug Patent Expirations: LOE Calendar & Pipeline

Analyze 2027 drug patent expirations and the impending patent cliff. Review a detailed loss-of-exclusivity (LOE) calendar for biologics and small molecules.

25 min read

4/30/2026

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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, the FDA Orange Book, FTC delisting actions, and the 2024 Teva v. Amneal Federal Circuit ruling.

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

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