tag:blogger.com,1999:blog-4241416962008169508.post2852528184904317396..comments2024-03-27T21:03:58.972-04:00Comments on Just A Life Sciences Blog...: NOT Claritin -- on Clarinex® Redi-Tabs Potential $800 Million Patent Vulnerability. . . .Unknownnoreply@blogger.comBlogger4125tag:blogger.com,1999:blog-4241416962008169508.post-30672781299562125142008-05-01T05:34:00.000-04:002008-05-01T05:34:00.000-04:00Right. Tongue firmly in cheek, here, but I simply ...Right. Tongue firmly in cheek, here, but I simply must: ". . .<I>and tutti frutti flavoring</I>. . . ."<BR/><BR/>What is <B>up</B> with that?!<BR/><BR/>Heh!<BR/><BR/>More seriously, now, I will withhold judgment here, given that not all the data we need to decide this matter is, as yet, available (though "<I>tutti-frutti</I>" suggests some marginally-humorous ribbing may be taking place, here!) -- we need to see Schering's federal court-filed-Replies to Orchid's Counterclaims, due to be filed by Schering's counsel very shortly, now, but the mere fact that an FDA-filed-<I>label-copy</I> document recites and/or suggests that a basic salt is present in the RediTab formulation is NOT the same thing as <I>actually</I> showing me that either (1) that <B>all</B> RediTabs ARE, in fact, made of a basic salt, or (2) in the alternative, a patent-filing (in which the filing claims, and is granted, a patent on the active ingredient, the metabolite of desloratadine, <B>WITHOUT</B> any basic salt present, in the actual football.<BR/><BR/>That -- the second branch, above --is, as I understand it, Latham & Watkin's contention -- that the RediTab version actually contains <B>no</B> basic salt -- <I>viz</I>:<BR/><BR/>". . . .<I>However, as the FDA-approved label for Clarinex® RediTabs confirms, Schering’s orally disintegrating formulation does not contain a basic salt. June 26, 2002 Final Draft Labeling at 1</I>. . . ."<BR/><BR/>Thus, that formulation would not be covered by any existing Schering patent, at all. <BR/><BR/>And so, all the suggestions of an "at risk" launch by Orchid are floating about.<BR/><BR/>Again, do stop back and correct my errors. I am sure I've made some.<BR/><BR/>Thanks!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-42250412524932849102008-04-30T20:39:00.000-04:002008-04-30T20:39:00.000-04:00Actually, I made a mistake above. Dibasic calcium...Actually, I made a mistake above. Dibasic calcium phosphate dihydrate USP is an excipient in the tablet. The basic salt excipient used in the reditab appears to be sodium bicarbonate USP. See the label below that I copied from the FDA's website (approved on 12/14/2006).<BR/><BR/>"The CLARINEX RediTabs® brand of desloratadine orally-disintegrating<BR/>tablets are light red, flat-faced, round, speckled tablets with an “A” debossed on<BR/>one side for the 5 mg tablets and a “K” debossed on one side for the 2.5 mg tablets.<BR/>Each RediTabs Tablet contains either 5 mg or 2.5 mg of desloratadine. It also<BR/>contains the following inactive ingredients: mannitol USP, microcrystalline cellulose<BR/>NF, pregelatinized starch, NF, sodium starch glycolate, USP, magnesium stearate<BR/>NF, butylated methacrylate copolymer, crospovidone, NF, aspartame NF, citric acid<BR/>USP, sodium bicarbonate USP, colloidal silicon dioxide, NF, ferric oxide red NF and<BR/>tutti frutti flavoring."Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-39671777751109624172008-04-30T08:57:00.000-04:002008-04-30T08:57:00.000-04:00Right. Thanks, Ashley, and welcome!So -- are you i...Right. Thanks, Ashley, and welcome!<BR/><BR/>So -- are you inferring that it is<BR/>simply a mis-labeling issue? Does<BR/>Schering hold a separate patent on<BR/>a form of the compound that is NOT<BR/>from a "basic salt"?<BR/><BR/>I think that is the crux of what<BR/>Latham & Watkins means to suggest.<BR/><BR/>But patent law is not my specialty,<BR/>so do inform me if I am missing something.<BR/><BR/>Thanks, c'mon back!Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-4241416962008169508.post-23418803504785971262008-04-29T23:37:00.000-04:002008-04-29T23:37:00.000-04:00That patent you're referring to, 6100274, is for t...That patent you're referring to, 6100274, is for the formulation which contains a salt. Namely, dibasic calcium phosphate dihydrate USP. You can see this on the label for Clarinex Redi-tabs.<BR/><BR/>The patent states, "Stable pharmaceutical compositions containing 8-chloro-6,11-dihydro-11-(4-piperidylidene)-5H-benzo[5,6]cycloheptic[1,2-b ]pyridine("DCL") and a DCL protective amount of a pharmaceutically acceptable basic salt such as calcium dibasic phosphate and an amount of at least one disintegrant, preferably two disintegrates such as microcrystalline cellulose and starch sufficient to provide dissolution of at least about 80% by weight of the pharmaceutical composition in about 45 minutes and suitable for oral administration to treat allergic reactions in mammals such as man are disclosed."Ashleyhttps://www.blogger.com/profile/03143487905032867378noreply@blogger.com