Tag: Paragraph IV certification

Tentative Approval and Patent Litigation: Navigating the Path to Generic Market Entry

Apr, 26 2026| 11 Comments

Learn how tentative approval works in the US generic drug market, the role of patent litigation, and how to avoid costly delays during market entry.

Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Before Market Entry

Dec, 15 2025| 15 Comments

Paragraph IV certifications let generic drugmakers challenge brand-name patents before launch, speeding up cheaper alternatives. This legal tool under the Hatch-Waxman Act has saved consumers trillions and reshaped pharmaceutical competition.