Branded Generic EXR

Starts promotion next month - don't think it will be a big deal - my sales can't get worse. Will it be like a Paxil /Pexeva thing?

Originally Posted by Anonymous

Starts promotion next month - don't think it will be a big deal - my sales can't get worse. Will it be like a Paxil /Pexeva thing?

Not if AB rated, then it's just a substitution. What company?

The first patent for Effexor XR expired in June 2008.

It is interesting to note here that Wyeth's ER product is a capsule while Sun's ANDA is for a tablet product.

Following its spat with Taro, the Israeli pharma major, over a failed merger, Sun is set to face some anxiety over its plans to launch the generic version of US pharma giant Wyeth’s $2.4 billion anti-depression and anxiety disorder drug Effexor XR.

US-based Osmotica Pharmaceuticals, which has received the US Food and Drug Administration (FDA) approval for marketing generic Effexor, has filed a citizen’s petition requesting the FDA to ask all subsequent filers for tablet versions to re-submit their abbreviated new drug applications (ANDA) applications proving bioequivalence to Osmotica’s product as the reference listed drug (RLD).

Sun is awaiting “non-AB rating” approval (certifying that its product is non-identical to others) for marketing Effexor tablets in the US and had filed the ANDA last year. The approval is expected anytime this year after the patent expired on June 13, 2008.

The company has also received a “will not sue” covenant from innovator Wyeth and had announced that it will launch Effexor XR as soon as it gets regulatory approval.

The petition from Osmotica could however, spoil the game for Sun. Although the company feels Osmotica’s move is to delay its launch, Sun expects the problem will be resolved.

“Since there has been no indication from the FDA for a specific date for approvals, we cannot say that the delay is because of the petition,” a company spokesperson told DNA Money.

The spokesperson added that now it’s the FDA which has to move and right now Sun needs to wait and see.

However, analysts are keeping fingers crossed because, even as the FDA looks into the petition, it could delay Sun’s entry in the market, translating into a loss in opportunity and therefore negative financial impact on its books.

Vihari Purushothaman and Rohita Sharma of Enam Securities said in a note the opportunity for Effexor may also be lost if Sun seeks legal intervention, as ANDAs for generic Effexor-XR capsules may be approved and launched in the interim.

Sun did not disclose its revenue targets and marketing strategies for Effexor, which is thought to be a $2.4 billion opportunity.

However, the company had earlier told analysts during the annual results that it expects a gradual pick-up of sales and continue to explore avenues such as mail order or PBM to promote the generic Effexor XR equivalent.

“Since there are no precedents for a non-AB rated product of this size and magnitude, it is difficult to state a target market share number, but in our opinion it would likely be a slow and steady increase,” Dilip Shangvi, chairman and managing director of Sun, had said during the analyst conference call.


Separately, management did not tell you that Under the terms of a settlement, in 2008 Wyeth has granted IMPAX a
license that would permit IMPAX to launch its capsule formulation of
Effexor XR on or after June 1, 2011, subject to earlier launch in
limited circumstances, but in no event earlier than January 1, 2011.
IMPAX will pay Wyeth a royalty on sales of this generic product.

The parties have also entered into a co-promotion agreement under
which IMPAX will utilize its neurology-focused sales force to detail a
product to be named by Wyeth in exchange for a fee for each detail
delivered. Other terms of this agreement are confidential and were not
disclosed.

Impax to promote Pristiq when a generic XR comes out??????

Upstate Pharma - which is a generic unit of UCB Pharma is promoting venaflaxine XR (name not yet approved) starting in October, reps are going to be through Ventiv, not sure if their PC reps or CNS reps will also carry it. The territories are going to be large and they will be sampling.

AB rated branded venlafaxine extended release. Decision on name due next week

Here's the story; Sun Pharma which is an Indian company filed an ANDA along with several other generic companies for Effexor XR. Sun was the only company that figured out how to put the drug into a pill as opposed to a capsule.

Earlier this year, Wyeth signed an agreement not to sue Sun and allowed them to put their version of Effexor on the market. Teva has the right to sell this drug starting in around June 2010. This is why the contract is for about 20 months with no rollver possibility.

As Sun typically markets only generics, they have no sales arm in the US so they are contracting with UCB who in turn is filling in some holes in their coverage area with this contract.

As opposed to Sun, you may be familiar with a company called Carrico which is the American name of the same company.

Also included is Tussionex because there is the distinct possibility that UCB is getting rid of their Primary Care Unit and we may be working with their CNS group to market this product.

This product is expected to generate between 350 and 425 million.

Reps are finalized next week and hit the field in October.

THE PP is from the VENTIV site

WTF??!!
Why does Wyeth keep telling us the patent doesn't expire until 2011??

Because Wyeth lies ... duh.

all wrong, these product has a new dosage of 225 mgs, that changes everything

Whatever its the same - check the Ventiv board

When is the patent protection for Effexor XR about to expire?
Also when Teva enters the market in Jun 2010 to sell the same product, is it that Osmotica would not be allowed to sell its products?