Orange Book Insights^TM

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...

Welcome to the start of a new Orange Book year! We are now in Volume 39. Early last week, the FDA released their January 2019 (Vol. 39, Supp. 1) Orange Book raw data. So I went right to work updating my Orange Book Companion ®. Here are a few observations about Supplement 1: We had a light month of patent listings. Only 35 new patents were listed. Maybe a New Years hangover? That number has to be considered even lighter when we take into account that over half of those 35 patents were listed for a single product! Acorda’s INBRIJA (levodopa) had 18 patents listed. INBRIJA is an inhalable levodopa for treating Parkinson’s disease. Uncharacteristically for an inhaled drug, none of the 18 patents are directed to the inhaler device. We have a new process patent in the Orange Book. The claims are all directed to “a method of making a gel.” Unlike last month’s process patent, the claimed process is directed to making a product directly related to the approved drug. That makes 11 ...

The FDA recently released their Supplement 12 Orange Book raw data. So I went right to work updating my Orange Book Companion ®. Here are a few observations about Supplement 12: Fifty new patents were listed in the Orange Book. Not out of the ordinary. However, 21 of those patents solely claimed methods of use or of improving a treatment. From my experience, that seems to be a pretty high percentage of method patents. A new patent on using cocaine was listed. This new patent continues claiming uses of the topical numbing effect of cocaine. In this case the numbing is limited to the nasal mucosa, and there are no restrictions on the patient population as in the previously listed patents. Another case of transposed digits resulted in a process patent being listed. The patent claimed a method of making a membrane for water purification. When I searched for patents owned by the NDA holder I found one whose number was nearly identical to the listed patent, except two digi...

Just a little reminder that drugs with a marketing status of “Discontinued” in the FDA’s Orange Book should have up-to-date patent listings. Patent listings for discontinued strengths are especially important when there are strengths of the drug that are still being marketed. Without listed patents, an ANDA approval (if the strengths were not discontinued for safety or efficacy reasons) or a 505(b)(2) approval could occur without warning based on a Paragraph I or a “no relevant patents” certification. When I was testing new code to add patent submission dates to my   Orange Book Companion   I discovered that Sun Pharmaceuticals’ XIMINO (minocycline HCl) had marketed strengths with listed patents and discontinued strengths without any listed patents. XIMINO was originally approved under 505(b)(2) with five equally spaced strengths: A-E. Later the two intermediate strengths, B and D, were discontinued. Seven patents are now listed for strengths A, C and E, but no paten...