Tag: Orange Book

Pediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patents

Pediatric exclusivity gives drugmakers six extra months of market protection after completing FDA-requested studies in children. It doesn't extend patents-but it blocks generics from entering the market, even after patents expire.

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Generic Patent Case Law: Landmark Court Decisions That Shape Drug Prices

Landmark court decisions in generic patent law shape how quickly affordable drugs reach patients. From Amgen v. Sanofi to Amarin v. Hikma, these rulings define the line between innovation and competition-and directly impact drug prices.

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