Paragraph IV patent challenges let generic drug makers legally fight brand drug patents before they expire. This system, created by the Hatch-Waxman Act, saves consumers billions and drives 90% of U.S. prescriptions to generics.
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Drug patents are often said to last 20 years, but in reality, most drugs have only 7-12 years of market exclusivity due to lengthy approval times. Learn how patent extensions, regulatory exclusivity, and layered protections affect when generics become available.
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Authorized generics let brand drugmakers launch identical copies of their own drugs during the first generic's exclusivity period, crushing competition and keeping prices high. Here's how it works and why it's under fire.
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