Showing posts from February, 2020

Teaching Old Drugs New Tricks

BYDUREON BCISE patent delisting requests: Now you see them, now you don’t

I am finally coming up for air after our move back to Pennsylvania after twenty-eight years in New Jersey. So I will be focusing my next few posts on some interesting things that occurred in Orange Book Land over the last several months.  However, I never let our move delay me from making the monthly updates of my Orange Book Companion® subscription service!
Orange Book Volume 39, Supplement 8 for 2019 showed that AstraZeneca’s BYDUREON® BCISE (exenatide) had six new patents listed. Ho hum! What was more interesting was the addition of fifteen new Use Codes (U-2588 to U-2602) to the new and already-listed BYDUREON BCISE patents. Fifteen? Where did those come from? A look at the Drugs@FDA database showed that BYDUREON BCISE received approval for seven supplements on July 25. Quite a load! So those approvals might have been the source of the new Use Codes.
But that is not the end of the story. The very next month, the FDA’s Supplement 9 data showed that ten of the BYDUREON BCISE patent…