Tag: Hatch-Waxman Act

3 July 2026 · 0 Comments

How Brands Use Formulation Patents to Extend Drug Exclusivity

Discover how pharmaceutical brands use formulation patents on drug combinations to extend market exclusivity, bypassing generic competition through strategic IP layering and regulatory loopholes.

Patent Term Restoration (PTE): How It Extends Drug Patent Life

Patent Term Restoration (PTE) lets drug makers recover lost patent time due to FDA delays. It’s a legal tool that extends exclusivity by up to five years-but only if strict rules are followed. Here’s how it works, who uses it, and why it affects drug prices.

How Brand Manufacturers Produce Their Own Generic Versions

Brand-name drug makers often launch their own generic versions when patents expire. These authorized generics are identical to the original drug but sold under a different label. Here’s how and why they do it - and what it means for your prescription costs.