How do I find out when a patent or marketing exclusivity expires and when a generic drug will become available?
Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the Patent and Trademark Office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to a New Drug Application (NDA) applicant if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition. You may find patent and exclusivity information in the electronic Orange Book at http://www.fda.gov/cder/ob/: search for the drug by name, click on an Application No, and then click on Patent and Exclusivity Information. However, since patents and exclusivities can be issued for many different reasons, it is not possible to tell when a generic will be allowed on the market. You may read m
