Tag: Hatch-Waxman Act

Market Exclusivity Extensions: How Pharma Companies Extend Monopolies Beyond Patents

Posted By Kieran Beauchamp    On 15 Dec 2025    Comments (10)

Market Exclusivity Extensions: How Pharma Companies Extend Monopolies Beyond Patents

Market exclusivity extensions let pharmaceutical companies delay generic competition for years beyond patent expiration using FDA-granted protections like orphan drug status and pediatric extensions. Here's how they work-and why they're costing patients billions.

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Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence

Posted By Kieran Beauchamp    On 12 Dec 2025    Comments (8)

Orange Book Database: FDA's Approved Drug Products With Therapeutic Equivalence

The FDA's Orange Book database lists approved drugs, their patents, and therapeutic equivalence ratings - helping pharmacists, generic manufacturers, and patients know when cheaper alternatives are legally available.

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