Tag: Hatch-Waxman Act
Patent Exclusivity vs Market Exclusivity: Key Differences Explained
- By : Archer Hamilton
- Date : Jul 16 2026
Understand the critical differences between patent exclusivity and market exclusivity in pharma. Learn how FDA and USPTO protections work, their durations, and why non-patented drugs can still block generics.
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.
First Generic vs Authorized Generic: How Timing of Market Entry Changes Everything
- By : Archer Hamilton
- Date : Dec 8 2025
First generics and authorized generics may look the same, but their market entry timing creates vastly different outcomes for prices, competition, and patient access. Here’s how brand companies use authorized generics to undercut the first generic’s exclusivity.
