Tag: Hatch-Waxman Act

180-Day Exclusivity: How Patent Law Delays Generic Drug Entry

180-Day Exclusivity: How Patent Law Delays Generic Drug Entry

The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly, but it's often used to delay market entry - costing patients billions in higher drug prices.

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Patent Litigation: How Authorized Generics Affect Competition in Drug Markets

Patent Litigation: How Authorized Generics Affect Competition in Drug Markets

Authorized generics are branded drugs sold under generic labels, often launched by the original manufacturer to undercut independent generics. They reduce competition, delay price drops, and are increasingly under regulatory scrutiny for anti-competitive practices.

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