Orange Book Insights^TM

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...

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...

This blog entry is not so much about Orange Book Supplement 5 (May 2019) (see the end of this posting for that). Instead, it is a warning about the ramifications of not seeing expiration date issues, regardless of whether they were created by you or the FDA, in the Orange Book. What brought this issue to my attention ? I was making needed changes to the computer code that generates the Orange Book Archive™ (“ OBA ”) section of my  Orange Book Companion ® (“ OBC ”). Over the last few years, whenever the FDA made changes to its raw data files I would take the lazy route of making minor changes to the computer code which would make the new data files look like the old data files. In that way I did not have to make major changes to the downstream computer code. For my update of the  OBA  to include 2018 expirations I decided to bite the bullet and make the major revisions that would allow my code to use the FDA’s current data file format directly. No more retrofitt...

This blog entry for Orange Book Supplement 4 (April 2019) may be late, but the Supp. 4 update of my  Orange Book Companion ® was not! In this case, my updating was already complete by the day that the FDA’s “CDER New” newsletter announced the update. So, what was new in the Orange Book in April? A new patent was listed for GOPRELTO (cocaine HCl 4%). The claims cover the aqueous cocaine solution in an  amber  bottle. I checked the file and did not find any specific reason for the bottle color limitation. There is now also a stability limitation. Not too surprisingly the claims were rejected, among other things, for obviousness-type double patenting over a previous patent and a pending application. That was overcome by a terminal disclaimer. Last month I mentioned that it would be interesting to see if Pfizer’s IBRANCE would receive three-year exclusivity for a label expansion to include treating breast cancer in men. This label expansion was based predominately on...

Last week the FDA released a guidance entitled “Determining Whether to Submit an ANDA or a 505(b)(2) Application” to help companies choose between those two routes for the approval of a proposed drug that contains an already-approved active ingredient. You can download the guidance directly from  here . After reading through the guidance, I came to the conclusion that the major difference between ANDAs and 505(b)(2) applications can be found where it states: The types of studies that may be submitted in a 505(b)(2) NDA may include clinical investigations to establish the safety and/or effectiveness of a product. Generally, ANDA applicants also have significant flexibility in the types of studies, data, and information they may submit in an ANDA to support the requirements for ANDA approval,  so long as clinical investigations are not submitted to establish the safety or effectiveness of a product . Page 7, Section B, Subsection 1. (emphasis added) So there you hav...

Last week the FDA released their March 2019 (Vol. 39, Supp. 3) Orange Book raw data. Here are a few observations about Supplement 3: We had another light month of patent listings. Only 37 new patents were listed in March. Most surprising was the lack of patents claiming new compounds. Only one of the newly listed patents had traditional compound claims. Two patents were delisted in March, and unlike in February the reasons were quite obvious. The patent that was listed for Kaleo’s EVZIO (AUTOINJECTOR) as a result of a typo in the patent number has been delisted and replaced by the correct patent, 10,143,792. The other delisting was carried out because 9,085,601 that had been listed for Astellas’ LEXISCAN was reissued. Here is something to look for in the April (Supp. 4) data that will be released by the FDA in mid-May. On April 4 the FDA approved Pfizer’s IBRANCE in combination with an aromatase inhibitor or fulvestrant for HR+, HER2- advanced or me...

In mid-March the FDA released their February 2019 (Vol. 39, Supp. 2) Orange Book raw data. I updated my Orange Book Companion ® right away, but here are a few somewhat overdue observations about Supplement 2: We had another light month of patent listings. Only 36 new patents were listed in February. Are we still in a New Years hangover? Unlike last month no single product dominated the new listings. Three patents were delisted well before their expiration dates. I could not find any IPR decisions or patent listing disputes for those patents. One NDA holder delisted two of those patents from one of its products and listed them for another of its products. Maybe just a mix up during the listing process? If so, this is another example of why companies need to pay special attention to their end-to-end patent listing workflow. Pfizer received a three-year “miscellaneous” exclusivity (M-237) for CHANTIX based upon their completion of a study “to determine whether varenicline, as...