Tag: Hatch-Waxman Act

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

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

Paragraph IV certifications let generic drug makers challenge brand-name patents before launch, accelerating affordable drug access. Learn how the Hatch-Waxman Act enables this system, why it saves billions, and how companies navigate legal battles over patents.