Tag: Hatch-Waxman Act
FDA's 180-Day Exclusivity: How First Generic Applicants Gain Market Advantage
Maddie Shepherd
Dec
8
10
Comments
FDA's 180-day exclusivity gives the first generic drug applicant a head start on the market, but it's often used to delay competition. Learn how it works, who benefits, and why reforms are coming.
More Detail
What is an ANDA? Abbreviated New Drug Application Explained for Generic Medicines
Maddie Shepherd
Dec
5
14
Comments
An ANDA is the FDA pathway that lets generic drug makers prove their products work just like brand-name drugs - without redoing costly clinical trials. It’s how 90% of U.S. prescriptions are filled at a fraction of the cost.
More Detail
Patent Litigation and Generic Entry: How Paragraph IV Drives Affordable Medicines
Maddie Shepherd
Nov
16
12
Comments
Paragraph IV under the Hatch-Waxman Act lets generic drug makers challenge brand patents to bring cheaper medicines to market faster. Learn how it works, why it matters, and how it saves billions for patients.
More Detail