Big Change to the Orange Book

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) contained a provision that would change the NDAs for biological products to BLAs after the tenth anniversary of the BPCIA’s enactment. [See section 7002(e)(4) of the BPCIA]. Well, March 23 was that 10th anniversary! In honor of that event, the FDA deleted all of the biologic products that were listed in the Electronic Orange Book. Poof, gone! (Except, for some reason, Sanofi’s LANTUS and LANTUS SOLOSTAR (insulin glargine) products are still showing up in an EOB search for "insulin." I have a question about that pending with the Orange Book staff).
Also in honor of this event, the FDA issued a new version of Volume 40 of the Orange Book in PDF format. That new version, dated March 20, 2020, freezes in time all of the Orange Book listings that existed just days before the deletion of the biologic products. So if you want a snapshot of biologic products prior to the switch from NDA to BLA, you should download tha…

A non-Corona Virus Posting: Teaching a really ancient drug a new trick

But First, the Cocaine Saga Continues
In Supplement 10 of Orange Book Volume 39 Genus Lifesciences listed another patent (10,420,760) for its cocaine hydrochloride product, GOPRELTO. It is the fourth method patent listed for GOPRELTO that is directed to a method of inducing local anesthesia. In this case, the inventors added the patient’s glomerular filtration rate as a new limitation in the claims. 
Teaching a Really Ancient Drug a New Trick
We all know of a really ancient drug (think back to biblical times!) that is still widely used today. That is ethyl alcohol (a.k.a. “ethanol” or simply “alcohol”). Of course, it is used mainly as a recreational drug. But then again, you may have known or heard of people who imbibed a distilled spirit on a regular basis strictly for “medicinal purposes.” I can still recall seeing my dad taking a single shot of some sort of whiskey every evening after dinner. Although I do not think I ever knew his medicinal purpose.
I recently discovered that ethano…

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…

Update on the “Raising Arizona” Metaphor Missing Patent for OSENI

Back in October I blogged about an Orange Book listed patent, 6,329,404, that disappeared from the Orange Book for one of six strengths of Takeda’s OSENI® (alogliptin benzoate/pioglitazone HCl). The FDA had apparently not updated the expiration date for the 12.5/45mg strength (Prod. No. 006) when Takeda filed their 3542 form to inform the agency that their patent had received a Patent Term Extension (“PTE”). The patent’s expiration date had been updated for the five other OSENI strengths. So when the 2017 Orange Book was prepared, the FDA deleted the ‘404 patent from Prod. No. 006 due to its original, unextended expiration date in 2016 still being shown.
In addition to my blog posting, I made a phone call and sent an email to the Takeda contact person listed on their 3542 form. However, I never received a response. So I decided to take the bull by the horns and let the Orange Book Staff know about the missing patent. Unfortunately, this was about the same time as my wife and I were g…

"Raising Arizona" as a metaphor for a disappearing extended Orange Book patent

In the movie "Raising Arizona" a female ex-cop and her ex-con boyfriend conspire to kidnap a baby from a couple that recently had quintuplets. Their rationale was that, with so many babies in the house to take care of, the parents wouldn't notice that one was missing!
While the plot of "Raising Arizona" was absurd, you might also think that an NDA holder would notice when one of its Orange Book-listed patents went missing, right? Well, maybe not if the product had six strengths, each with eight patents listed, and the patent disappeared from the listings of only one of those six strengths. That is exactly what appears to have happened to a Takeda drug called Oseni® (alogliptin benzoate/pioglitazone HCl).
Patent 6,329,404 was originally listed in the February 2013 supplement of the Orange Book along with sixteen other patents for all six strengths of OSENI following the drug's approval in January 2013. On June 15, 2016 the '404 patent received a five-ye…

A disappearing Pediatric Exclusivity and other musings about the June 2019 Orange Book supplement

In mid-July the FDA released their June 2019 (Vol. 39, Supp. 6) Orange Book raw data. Here are a few observations about Supplement 6:
There were 47 new patents listed in June. Only four of the newly listed patents had traditional compound claims which does not include new polymorphs, salts or hydrates.
One patent was delisted in June. The patent, 8,759,316, had been listed for KENGREAL®(cangrelor) from Chiesi USA. The claims are directed to a method of transitioning a patient from administration of cangrelor during percutaneous coronary intervention (“PCI”, which is the more modern name for angioplasty with stent) to administration of cangrelor in preparation for surgery, or vice versa. Cangrelor is not in the latest Patent Listing Disputes list, nor is it in the July 16, 2019 “Paragraph IV Patent Certifications” list. The NCE-1 date occurred on June 22.
So why was the patent delisted? One thought that I had was based upon the lack of any mention in the KENGREAL label of the claimed “…