Pharmacy Question for the Week of March 25, 2019

Pharmacy Compliance Question of the Week

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.

Disclaimer: Every reasonable effort was made to ensure the accuracy of this information at the time it was published. However, due to the nature of industry changes over time we cannot guarantee its validity after the year it was published.