Posted by chemist on May 15, 2005, at 23:39:59
In reply to Re: ....patent expired » chemist, posted by Larry Hoover on May 15, 2005, at 9:06:09
> > hi larry, i posted a windy reply to this hours ago, yet i must have ditched it...
>
> Doncha HATE that? The second time around is never as good.*** i'm with you on that one: something about a wind that blows twice as hard blows half as long???? ***
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> > if you go to the 2003 archives of CDER, you will find the NDA # for Eldepryl, and in the 1997 archive, mention of - but no links that work (for me) - three (3) supplemental notations, likely the labeling and other changes. it appears that emsam is a ghost or a well-kept secret.
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> Right. Exactly. It's approved as anti-Parkinsonian.
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*** the recurring theme...yet absent of supporting documentation....****> > i am not aware of any reason why sundry letters would be held by the FDA/other...the closest thought i ahve - not borned by limited experience - is that if a drug is about to fill the shelves, then a media blackout from the gov't is warranted as it might fuel trading in financial markets. just a guess, and the NDA # for Eldepryl is 020647, approved 05/15/1996, labeling revision 08/06/1997, and control supplement 02/15/2001.
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> But, Somerset had another NDA, for the same drug, under 019334, which was simply withdrawn. Approved in 1989, so it's not expired yet.**** yes, yes, yes, and the date i have for #019334 is in reference to the changes in labeling, and was approved 06 AUG 1997 in concert with the labeling supplements for #020647:
http://www.fda.gov/cder/da/da0897.htm
i asserted that an NDA (or was it IND? no matter, in truth) for a new delivery route is not going to cut it: this statement is incomplete and untrue, and it is not clear to me why any company would invest time/money/etc. to go down that road, and the conditions that preclude such a path for granting an approval/responding with approvable status are rarely if ever met (including no intention to actually follow through with supplying results from trials that support efficacy for the same malady BUT with fewer adverse effects: why bother? answer: they do not)
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> > the NDA went to somerset, and therapeutic equivs for aaipharma, clonmel, and torpharm are given, although the reference - somerset's 5 mg selegiline HCl oral tablet - is TE == AB (unusual), and the generics are AB (par for the course...)....a mystery indeed...yours, c
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> So, I'm baffled. How does one get a therapeutic equivalent on a newly approved med? Only if there is no patent, right?**** preamble: the TE is assigned based on bioequivalence in vivo/vitro in reference to, well, the reference drug. if emsam exists and is marketed sometime: it will carry a TE of AA for one dosing strength, and to this all others will be measured. why eldepryl and the generics are all AB is beyond me, as this indicates that none of those medications are the reference, nor is the reference given. ??????? je ne sais pas....****
**** the breeze is back: again, there are ways to extend the patent life. the problem is that the 17 year term which would cover the 1989 listing (please direct me/others if you please, i cannot locate the NDA/IND/other for that date but would like to see the timing) expires in one year from now, but because the patent is granted for a drug long before it hits the market - if at all - the company holding it gets a reduced term. the legislative branch of the u.s. government made law that a 5-year extension - and this is a full extension, not an exclusivity such as with generics - is the maximum that can be added to make up for lost time. regardless, from FDA approval to patent relief (immediately followed by 6 months of exclusive generic marketing to one and only one lucky generic manufacturer before the market opens entirely), 14 years is the max - this is explained ad nauseum on the fda/cder sites...
now, the tricky part: if, upon tacking on 5 years to a drug that is approved, the 14 year term is exceeded, the 5 years is revoked. if a drug is approved one day after the nine-year mark from patent grant, the 14 years + 1 day immediately goes to 9 years and 1 day of patent exclusivity.
this leads to the 1989 withdrawl you cite (i am with you 100%, just lost in re: finding it): the drug was patented in the u.s. for the first time in 1986 to the Hungarian company Chinoin, thus the clock ran out in 2003 UNLESS supplemental labeling changes were made - and they were - and the drug was pushed along, before mylan and watson coalesced and went for the approval to which you refer. this is within the time that patents were granted for 17 years - 20 is the figure now, and for the last 10 years or so - and 3 years were lost (1986-1989, and no, the u.s. does not play the time-game based upon the much earlier french and danish patents for same drug, same company), and the 5-year extension had not yet come to light. so, looking at 11 years of marketing freedom, and maybe (???) this was incentive to pull the application: maybe the data were weak, maybe the truth - that eldepryl is to be used in concert with sinemet/sinemet CR (from somerset's own web site, where the ``physician's info'' in under construction and the site was last updated in 1998), a medication that was under patent to merck and marketed by dupont (according to the somerset site) - is that there just is not a large market for a drug that is to be added to a cocktail for a person suffering from parkinson's while incidentally lowereing the need for a drug not marketed by somerset. i certainly do not know, and the crop-circle/area 51 people are not in short supply if you take a brief tour of the web space out there, as the government conspiracy and cover-up theories concerning alleged deaths from the drug (???) are not in short supply.
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> And, it's quite clear that the FDA is hanging tough on the two reported cases of tyramine reaction, on 5 mg b.i.d. *oral* selegiline.**** why not? the low dose causality alone gives me pause. truth time: we are a society - the u.s., in my opinion - best characterized as looking for a lawsuit, whether merited or not. the FDA states that the risk is non-zero: fact. the consumer and prescriber ought to make it a point to address this, as it is a rare but severe reaction that might occur: who was the genius ingesting ephedrine and selegiline, for instance? and why should any entity be held responsible for such behaviour, including taxpayers who do not factor such acts into their budgets and lives? ***
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> No selegiline trial comes up at http://www.clinicaltrials.gov/
> Already done?**** who knows...for a drug patented in france in 1964, the 40+ year limbo seems rather bizarre to me...****
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> I checked the orange book listing for selegiline. There are 13 approvals, and the Somerset and Apotex products have been used by others as the comparator for substantial equivalency. There are no existing patents or exclusivity limits for selegiline.
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> Anyway. Hmmmphhh.
>
> Lar
poster:chemist
thread:496583
URL: http://www.dr-bob.org/babble/20050510/msgs/498350.html