Tag: generic drug entry
Predicting Generic Entry: How to Forecast When Your Drug Will Face Generic Competition
Learn how to predict when generic drugs will enter the market after patent expiration. Understand the legal, regulatory, and market forces that determine timing-and how to plan for revenue loss before it hits.
READ MORE180-Day Exclusivity in Generic Drugs: How Patent Challenges Delay Market Entry
The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly to incentivize patent challenges-but it often delays market entry for years, keeping prices high. Here's how it works and why it matters.
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