Articles tagged with “generic-drugs”

Dissolution Testing and Bioequivalence: f2 Similarity, Biowaivers

A 2026 analyst guide to dissolution testing and bioequivalence, covering f2 similarity factor calculation and its statistical limitations, USP apparatus types, BCS biowaiver rules under FDA, EMA, WHO and ICH M9, and IVIVC modeling.

46 min read

8/7/2026

dissolution testing bioequivalence f2 similarity factor biowaiver biopharmaceutics classification system bcs ivivc usp apparatus generic drugs fda guidance

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

drug patent expirations loss of exclusivity 2027 patent cliff loe calendar biosimilars generic drugs pharma pipeline biologics

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 analysis of the 2026 drug patent cliff: selected U.S. patent expirations and generic-entry dates, including Januvia, Xeljanz and Ozempic, and their impact on generic drug prices.

25 min read

11/15/2025

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