Posted by Larry Hoover on May 15, 2005, at 9:06:09
In reply to Re: ....patent expired » Larry Hoover, posted by chemist on May 15, 2005, at 2:44:48
> 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.
> 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.
Right. Exactly. It's approved as anti-Parkinsonian.
> 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.
But, Somerset had another NDA, for the same drug, under 019334, which was simply withdrawn. Approved in 1989, so it's not expired yet.
> 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
So, I'm baffled. How does one get a therapeutic equivalent on a newly approved med? Only if there is no patent, right?
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.
No selegiline trial comes up at http://www.clinicaltrials.gov/
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.