Tag: Hatch-Waxman Act

Jan, 15 2026

0 / Health & Wellness

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand-Name Patents

Paragraph IV certifications let generic drug makers legally challenge brand-name patents before market entry. This Hatch-Waxman Act tool saves billions annually by forcing patent disputes into court, rewarding first challengers with 180 days of exclusivity.

First-Mover Advantage: How First Generic Drug Manufacturers Dominate the Market

By Ewan Cranleigh

Nov, 17 2025

12 / Health & Wellness

First-Mover Advantage: How First Generic Drug Manufacturers Dominate the Market

The first generic drug manufacturer to enter the market after a patent expires captures up to 80% of sales during its 180-day exclusivity-and often holds 30-40% years later due to pharmacy and prescriber loyalty.

Tag: Hatch-Waxman Act

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand-Name Patents

First-Mover Advantage: How First Generic Drug Manufacturers Dominate the Market

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