First Pharmacy UK

Tag: Hatch-Waxman Act

18 Feb

FDA’s Abbreviated New Drug Application Process Explained: How Generic Drugs Get Approved
The FDA's ANDA process lets generic drugs reach the market faster and cheaper by proving they're bioequivalent to brand-name drugs. It's saved U.S. patients $373 billion since 2021 and powers 90% of prescriptions.

By: Lydia Penhaligon 0 Comments Read More
23 Jan

180-Day Exclusivity: How Patent Law Controls Generic Drug Market Entry
The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug maker to challenge a patent a temporary monopoly, delaying competition and keeping prices high. Here’s how it works-and why it’s broken.

By: Wellington Osawe 14 Comments Read More
4 Dec

Paragraph IV Certifications: How Generic Drug Makers Challenge Patents Before Launch
Paragraph IV certifications let generic drug makers challenge brand patents before launch, speeding up affordable drug access. This legal tool under the Hatch-Waxman Act saves billions annually but faces challenges from patent thickets and pay-for-delay deals.

By: Lydia Penhaligon 8 Comments Read More