Tag: Orange Book
Paragraph IV Certifications: How Generic Drug Companies Challenge Patents Before Market Entry
Paragraph IV certifications let generic drug companies challenge brand-name patents before launch, speeding up affordable drug access. Learn how the Hatch-Waxman Act enables this system-and why it’s saving billions.
How Pharmacists Verify Generic Equivalence: Practice Standards
Pharmacists use the FDA's Orange Book to verify that generic drugs are therapeutically equivalent to brand-name versions. This system ensures safe, legal substitutions that save billions while maintaining patient safety.