Tag: 180-day exclusivity

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Pharma Patents

Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Pharma Patents

Paragraph IV certifications let generic drug makers legally challenge brand-name patents before launch. This Hatch-Waxman tool saves billions annually and gives the first challenger 180 days of exclusive sales-if they navigate the legal minefield correctly.