Tag: Hatch-Waxman Act

2 May, 2026

What is an ANDA: Abbreviated New Drug Application Explained for FDA Approval

by Trevor Ockley | May, 2 2026 | | 0 Comments

Discover what an ANDA is and how it enables generic drug approval. Learn about the Hatch-Waxman Act, bioequivalence testing, and why this process saves the healthcare system billions.

2 Dec, 2025

Litigation in Generic Pharmaceutical Markets: How Patent Disputes Delay Affordable Medicines

by Trevor Ockley | Dec, 2 2025 | | 12 Comments

Patent litigation in the generic drug market is delaying affordable medicines, costing billions annually. Learn how the Hatch-Waxman Act, Orange Book listings, and serial lawsuits block competition-and what’s being done to fix it.