Dear Readers,
The news item below escaped my attention.
Teva has let an Indian company USV [which is an API maker for Carvedilol [Coreg] off the hook.
Here is the 07/Sep news item.
Interesting lines from the news item:
Last month, a lawsuit against USV was dismissed “without prejudice” by Judge John Hughes of the US district court for the district of New Jersey at Teva’s request. The judge also ruled that USV has the right to import carvedilol into the US. The verdict makes USV free to re-file a drug master file for carvedilol (base or phosphate).
...
K Rajendran, head, knowledge cell, USV, said, “This move by Teva may be interpreted as a market protection move aimed at stopping these future generic players as long as it can and reaping a financial windfall while it lasts.”
I would wait and watch on this one.. In Sertraline too, Teva first filed a suit against Torrent on 12th January 2007 [another Indian company] then let it off the hook on 15th February 2007 [the complaint was voluntarily dismissed by Teva without prejudice; am not completely sure for thier dismissal] and then sued them Torrent again on 25th May 2007.
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K Rajendran, head, knowledge cell, USV, said, “This move by Teva may be interpreted as a market protection move aimed at stopping these future generic players as long as it can and reaping a financial windfall while it lasts.”
I would wait and watch on this one.. In Sertraline too, Teva first filed a suit against Torrent on 12th January 2007 [another Indian company] then let it off the hook on 15th February 2007 [the complaint was voluntarily dismissed by Teva without prejudice; am not completely sure for thier dismissal] and then sued them Torrent again on 25th May 2007.
Meanwhile things are taking a curious turn on Pantoprazole [Protonix (R)].
Teva and Sun were in litigation with Wyeth for its drug Pantoprazole. The two companies had agreed with Wyeth that they would not launch the formulation until Sep 7th. Post this date, Wyeth moved for another preliminary injunction to prevent Teva from launching its generic version.
The district court denied Wyeth’s motion. The opinion denying Wyeth's motion was filed under seal. Only the final order, denying the injunction was released. Subsequently, Teva, in its press release said, "...[it] intends to complete a thorough analysis of today's decision before deciding upon its next course of action."
TEVA has, in the past settled with Wyeth for another drug- Venlafaxine and there is always a chance here too that it would settle as well.
{My coverage of the entire Wyeth/ Venlafaxine saga here}
INFO:
Teva, along with Sun is the joint first ANDA filer and hence both would benefit from the 180 day exclusivity.
Teva got the FDA approval in August, post the 30 month stay limit.
Sun, too, now has the approval.
Sun has stated that '..it is studying its options...' Here too no clear answers for launch :-)

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