Tag: Hatch-Waxman Act

5 March Caspian Delacruz 5 Comments

30-Month Stay: How Litigation Delays Generic Drug Approval

The 30-month stay under the Hatch-Waxman Act is a legal tool that delays generic drug approval when patent lawsuits are filed. It's meant to protect innovation, but often extends monopolies, hikes drug prices, and leaves patients waiting years for affordable alternatives.

5 January Caspian Delacruz 15 Comments

Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Before Launch

Paragraph IV certifications let generic drug makers challenge brand patents before launch, speeding up affordable medicine. Learn how the Hatch-Waxman Act enables this legal battle - and why it saves patients billions.