Tag: ANDA

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180-Day Exclusivity: How Patent Law Controls Generic Drug Market Entry

The 180-day exclusivity rule lets the first generic drugmaker to challenge a patent block competitors for six months. But delays in launch can extend this monopoly for years-keeping prices high and patients waiting.

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Hatch-Waxman Act: How Federal Law Made Generic Drugs Possible

The Hatch-Waxman Act created the modern generic drug system in the U.S., balancing innovation with affordability. It cut approval costs, sped up market entry, and saved over $1.7 trillion in healthcare spending.

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