Tag: Hatch-Waxman Act
FDA Therapeutic Equivalency Codes: How Laws Determine Drug Substitution
Learn how FDA therapeutic equivalency codes in the Orange Book determine if generic drugs can safely substitute brand names. Explore A vs B ratings, state laws, and the impact on healthcare costs.
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FDA's 180-Day Exclusivity: How It Helps First Generic Drug Makers Compete
FDA's 180-day exclusivity rewards the first generic drug maker to challenge a patent, but delays in launching can block competition and keep prices high. Here's how it works-and why reform is coming.
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Patent Law and Generics: How Patents Protect Innovation in Pharmaceuticals
Patent law protects pharmaceutical innovation by giving companies exclusive rights to sell new drugs, but the Hatch-Waxman Act ensures generics can enter the market fairly. This balance saves billions and keeps medicines affordable.
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