Effexor XR

[Navitushealth]

How confident are we that July 2010 will bring a new generic to market? Does anyone know if there are pending exclusivities for the drug?

I'm seeing a good deal of variability in the dates for a generic launch.

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[chantell.reagan]

As we reported in another discussion, (see Tips for estimating generics (scroll down for Effexor XR), Wyeth did report a final settlement with Teva, allowing their generic to enter the market in 7/2010. In the 2009 annual report (see 10-K 2/26/10), Pfizer confirmed the Teva settlement and the 7/1/2010 launch “or earlier, depending on specified market conditions or developments…” This timing was also confirmed in the Teva’s 2008 annual report. Finally, as recently as in 2/2010, industry analysts have also confirmed the anticipated launch of the Teva generic in 7/2010.

Additionally Impax, Lupin and Anchen also reached settlement with Wyeth to commence sales by 6/1/2011 and in limited circumstances possibly as early as 1/01/2011.

Of note, there is one exclusivity listed for the long-term treatment of social anxiety disorder, which expires in 12/14/2010 per the Orange Book; it is not expected to delay the launch of this generic.

Bottom line: It is likely that Teva’s generic will reach the market as expected by July 1, 2010 (due to their final settlement with Wyeth (Pfizer), with others to follow as noted above.

[david.calabrese]

Our understanding of current circumstances is consistent with Chantell's. Litigation has also been settled between Wyeth and various companies who have filed ANDA's. These include Impax, Mylan, Lupin, Anchen Pharmaceuticals and Teva Pharmaceuticals.

Teva will be able to launch a generic in July 2010, pending timing of FDA approval. The other companies will be free to introduce generics under license on or after June 1, 2011, subject to earlier launch in limited circumstances, but in no event earlier than January 1, 2011.

[darlene.mednick]

I have seen the same information about Teva, July 2010 or sooner.

[cvs1966]

My understanding is Teva will have Single Source rights for 11 months beginning in July of 2010. It will become Multi Sourced as of 6-1-2011.

[chantell.reagan]

Teva's generic venlafaxine ER capsules were approved by the FDA on 6/29/10, with shipment expected to begin today 7/1/10, per their exclusive agreement with Wyeth (source: Teva press release 6/10)

[Pantablo]

Can someone please confirm if Teva will be the only generic manufacturer or distributor for the extended-release version of this medication for the time being. If yes, does anyone know when other generics are slated to enter into the market, I've read some of the previous posts and cannot discern directly when that might be.

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[chantell.reagan]

Teva's generic has exclusivity until 1/2011 (per FDA approval letter). Then, it appears that according to settlements other generics will launch in 6/1/11 and in limited circumstances possibly as early as 1/01/11 (settlements have been reached with Impax, Mylan, Lupin, Anchen), unless generic companies proceed with at-risk launches. Bottom line: there won't be another generic until the end of 2010 and it's unlikely that we will see another generic enter the market before 6/1/11. Of note only Impax and Mylan have tentative approvals with FDA for their generics as of today 9/7/10.