Tag: generic drug entry
How Paragraph IV Certification Works: Patent Litigation and Generic Drug Entry
- By : Archer Hamilton
- Date : Jun 23 2026
Explore how Paragraph IV certification under the Hatch-Waxman Act enables generic drug entry by challenging brand-name patents. Learn about the 30-month stay, 180-day exclusivity, and the legal strategies driving down medication costs.
How Multiple Generic Drug Competitors Enter After the First Market Entrant
- By : Archer Hamilton
- Date : Dec 24 2025
After the first generic enters the market, prices crash-but not all at once. Multiple competitors trigger dramatic price drops, authorized generics disrupt the first mover, and manufacturing bottlenecks cause shortages. Here's how the race really works.