Tag: Hatch-Waxman Act

Multiple Generics: How Competitors Enter After the First Generic Market Entrant

After the first generic enters the market, prices crash - but the real battle is just beginning. Learn how competitors enter, why authorized generics hurt first entrants, and how PBMs and patent tactics shape the future of generic drug pricing.

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FDA’s Abbreviated New Drug Application Process Explained: How Generic Drugs Get Approved

The FDA's Abbreviated New Drug Application (ANDA) process lets generic drugmakers get approval without repeating full clinical trials. It's how 90% of U.S. prescriptions are filled at a fraction of the cost, saving billions annually.

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