Tag: generic drug entry

How Paragraph IV Certification Works: Patent Litigation and Generic Drug Entry

How Paragraph IV Certification Works: Patent Litigation and Generic Drug Entry

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

How Multiple Generic Drug Competitors Enter After the First Market Entrant

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.