Patent Expirations

Loss of exclusivity (LOE) marks when a drug's patent and regulatory exclusivity protections lapse, allowing generic or biosimilar competitors to enter the market. For companies with marketed products, the patent cliff can sharply erode revenue, while for competitors it opens a new commercial opportunity. Dates are sourced from the FDA Orange Book.

4 patent expirations tracked, next on Jul 1, 2026. Updated .

Frequently asked questions

What is loss of exclusivity (LOE)?

LOE is the point at which a drug's patents and FDA-granted regulatory exclusivities expire, permitting generic or biosimilar versions to compete — often causing steep declines in the originator's revenue.

Where do patent expiration dates come from?

These dates are sourced from the FDA Orange Book, which lists the patents and exclusivity periods associated with each approved drug application. BioSniper surfaces the latest-expiring protection per drug as the approximate generic-entry threshold.

Why does the patent cliff matter to investors?

A patent cliff can wipe out a large share of a marketed drug's sales within months of generic entry, making LOE timing a material catalyst for companies that depend on a small number of commercial products.