Twenty years or more can pass between a drug’s development and a Hatch-Waxman trial related to that drug. One key to a successful outcome against generic challengers in a Hatch-Waxman case is a compelling and factual invention story based on evidence that was created in real time—during the drug development and regulatory process.

Timing of Hatch-Waxman Litigation

The drug development process, by any standard, is very long. Although the exact timing varies considerably, clinical trials alone typically take six to seven years and that does not account for the drug discovery and preclinical testing work that must be done before clinical trials begin. From there, it can take several more years to go through the FDA review process before the drug can enter the market.

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