Pharmacy Question for the Week of March 25, 2019

Question:

How do I find out when a patent or marketing exclusivity expires and when a generic drug will become available?

Answer:

Patents and exclusivity work in a similar fashion but are distinctly different from one another.

The U.S. Patent and Trademark Office grant patents anywhere along a drug’s development and may encompass a wide range of claims.

The U.S. Food and Drug Administration (FDA) grants exclusive marketing rights 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.

More information can be found in the electronic Orange Book at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.

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 more about patents and exclusivity at Frequently Asked Questions on Patents and Exclusivity.