Orange Book Insights^TM

First, a couple of comments on Supplement 9 (September) of Orange Book Volume 39 (2019): There were 60 new patents listed, including one process patent. The process patent, 8,318,201, was listed for NOURIANZ (istradefylline) from Kyowa Kirin. All six claims are directed to “[a] method for suppressing formation of impurities due to dimerization” through “the step of providing iron oxide in the solid formulation.” Genus Lifesciences listed another patent (10,413,505) for its cocaine hydrochloride product, GOPRELTO. It is the third method patent listed for GOPRELTO that is directed to a method of inducing local anesthesia. A fourth method patent listed for GOPRELTO is directed to a method of administering a local anesthetic. Meanwhile, Hyman, Phelps & McNamara’s FDA Law Blog has a report from contributor Sara Koblitz about a new controversy concerning GOPRELTO. Genus Lifesciences is taking issue with the FDA’s acceptance of a second submission under 505(b)(

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 BYDURE