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Transcript: Patents and Exclusivity video

Return to Patents and Exclusivity page

Captain Mary Kremzner: The Orange Book, published by the FDA and now online is the go-to source for finding out when patents and exclusivity will expire.  Let's drill a bit deeper and learn more around the popular topic of drug patents and exclusivity.  Hi, I'm Captain Mary Kremzner and this is Drug Info Rounds brought to you by the pharmacists in the FDA's Division of Drug Information.  I'm joined today by two FDA pharmacists, Lieutenant Beth Carr and Dr. Lindsay Davison who will explain these important product protections.  Beth, let's begin our discussion clarifying something.  What is the difference between patents and exclusivity?

Lieutenant Beth Carr: Well, patents and exclusivity work in similar ways but they are two distinct forms of protection.  Drug patents are granted by the U.S. Patent and Trademark Office to protect drug sponsors' investments and prevent other manufacturers from entering the market with the same product.  Drug manufacturers can file for a patent at any point during the drug's development lifeline.  And a patent can encompass a wide range of claims.  Exclusivity is granted by the FDA and refers to the exclusive marketing rights that the FDA gives a company upon approval of a new drug application.  The idea behind exclusivity is to promote a balance between new drug innovation and generic drug competition.  A patent typically expires 20 years from filing.  There are other factors that can affect a patent's duration like patent term extensions; however, the exclusivity granted to a drug after its approval does not extend the patent life.

Dr. Lindsay Davison:  With exclusivity, the timing all depends on the type of approval.  For orphan drugs, exclusivity is granted for seven years.  For new chemicals, it's five years.  There's also an "other" category that grants three years of exclusivity for a change, as long as the change meets certain criteria.  With pediatric exclusivity, the FDA adds a period of six months on all applications held by the sponsor for that drug.  The last type of exclusivity is for a patent challenge.  This is granted for 180 days and applies only to abbreviated new drug applications or ANDAs.  If you look in the Orange Book listing under the patent column, you'll see the patent appears twice; once with its original expiration date and once reflecting the period of exclusivity linked to that patent.  Similar listings are found in the exclusivity column.  Some drugs have both types of protection and some have just one or none at all.  The FDA only includes active patents and exclusivity information in the Orange Book, not those that have expired.  Patent information is updated daily and exclusivity information is updated monthly.

Captain Mary Kremzner:  That will definitely make it easier for healthcare professionals to find what they're looking for, not to mention enabling them to understand the differences between the two types of protection.  If you have questions about drug patents and exclusivity, call or email the FDA's Division of Drug Information.