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mcbio

10/20/10 7:06 AM

#106694 RE: ghmm #106693

Re: Teva/Novopharm/generic Lovenox

Appreciate the info and thanks also pollyvonwog for getting the info from the company. This blurb gives a little more info on genisi's comments:

www.smart-biggar.ca/Assets/RxIPUpdate_Jul05.pdf

Quote:
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Novopharm received its NOC for a generic version of LOVENOX ("Novo-enoxaparin") on February 28,
2005, and Aventis has commenced an action for patent infringement against Novopharm. Judge
dismisses Aventis' motion for an interlocutory or interim injunction to restrain Novopharm from, among
other things, selling Novo-enoxaparin pending trial. Judge finds that Aventis failed to demonstrate that
it will suffer irreparable harm if an injunction is not issued. Aventis has appealed.
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I think Teva will eventually launch but having it not developed in house would lead me to think it is more probable to be later then sooner.

Just to further drill down on this, I did a Google search of "Teva Novopharm Lovenox" and found the following article that seems to imply that it is indeed Novopharm that is behind Teva's generic Lovenox: http://www.pharmaceutical-market-research.info/research/PMAAABIX-Injectable-Generic-Drugs--Prospects-and-Opportunities-to-2010.shtml . In particular, "Lovenox/Clexane (enoxaparin), with sales of over US$2.8 billion in 2005, of which US$1.6 billion was in the US. There have already been a number of ANDA applications for generic enoxaparin, including from Amphastar and Teva in 2003, which have been the subject of patent infringement litigation. More recently, Novopharm (Teva) and Momenta Pharmaceuticals have submitted ANDAs for generic enoxaparin."

So now, the big question assuming this article is accurate, how up to the task and ability is Novopharm in creating a generic Lovenox to the standards of MNTA?

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HattieTheWitch

10/20/10 10:51 AM

#106720 RE: ghmm #106693

I think Teva will eventually launch but having it not developed in house would lead me to think it is more probable to be later than sooner.

(my emphasis)

Why do you say that? It's certainly in TEVA's interest to get it done, and I would expect they would use all resources available to make that happen sooner, rather than later?