Orange Book Insights^TM

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...