Nature Biotechnology  |  July 14, 2023

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Drug patents that are given patent term extension are important bellwether indicators for generic drug market entry.

After the US Food and Drug Administration (FDA) approves a new prescription drug, the drug is protected by a period of market exclusivity in which there is no direct competition from generic or biosimilar versions. During this time, manufacturers charge high prices to earn revenues and cover the costs of research and development, so the length of time of market exclusivity is crucial for commercial success in the drug industry. That market exclusivity is originally set by the key original patent on the product, which usually covers its active ingredient1. Patents are granted by the government and last 20 years. However, since prescription drugs go through a long process of R&D leading up to FDA approval, some portion of that 20-year period lapses before the drug can be approved and widely sold. Studies show that market exclusivity lasts for an average of 14–15 years for small-molecule drugs, and even longer for biologics2.

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