Tag: Hatch-Waxman Act

History of Generic Drugs in the United States: How They Became 90% of Prescriptions

History of Generic Drugs in the United States: How They Became 90% of Prescriptions

Generic drugs now make up over 90% of U.S. prescriptions, saving billions annually. Their history spans from 19th-century drug standards to the Hatch-Waxman Act and modern supply chain challenges.

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.