Orange Book Blog

AstraZeneca recently filed a Request for Advisory Opinion with the FDA, asking for a determination "whether patents on drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formation," should be listed in the Orange Book.  GlaxoSmithKline submitted a request to the FDA in January, 2005, asking the very same question, which AstraZeneca attached to its filing.

Interestingly, AstraZeneca reveals toward the end of its request, "Because AstraZeneca believes that such patents should be listed, AstraZeneca will continue to list them unless it receives guidance from  FDA that such listings are improper."  Of course, Orange Book listing is a predicate to a 30-month stay of FDA approval of any generic equivalents, as well as to 6-month marketing exclusivity after any successful generic patent challenge.

NOTE:  Thanks very much to Kurt Karst for bringing this FDA filing to my attention.