Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from Randall Stanicky from Goldman Sachs.
Bob - Goldman Sachs
Hi, good morning guys. This is actually Bob [ph] on for Randall this morning. Paul just quickly on the guidance, I guess could you may be help us understand, what gives you more confidence today to include more Toprol XL in the guidance for this year?
Paul Bisaro
Sure, conversations with the FDA.
Bob - Goldman Sachs
So we should expect that very near-term over the next quarter, how should we think about that?
Paul Bisaro
We expect the approval in the near term.
Bob - Goldman Sachs
Okay, great. Then just on the announcement on the license agreement for generic Ferrlecit, just a couple of questions, is there any risk from Sanofi trying to prevent you from selling this product? Is there any non-compete clause that we should think about?
Paul Bisaro
No, no that is no provisions like that.
Bob - Goldman Sachs
And then any update on the CPs for Ferrlecit?
Paul Bisaro
Well, the CPs are still pending at the FDA, and since they are still pending we are not prepared to discuss them at this time. What I will say is we have done extensive due diligence on the GeneraMedix product, and we are comfortable with it.
Bob - Goldman Sachs
So this expedited ANDA process doesn't have anything to do with the CPs?
Paul Bisaro
They are completely -- those two things are completely separate.
Bob - Goldman Sachs
Okay, and then last question just on Plan B, can you remind us when we should expect the OTC version of that product, and then how should we think about the market considering obviously the Plan B One-Step that is coming and obviously the branded product that is already on the market?
Paul Bisaro
What a question there.
Bob - Goldman Sachs
(inaudible).
Paul Bisaro
I believe the OTC exclusivity for Plan B expires near the end of this year, I think it is October. I think it would be fair -- I am sorry, August. I think it is fair to say that we would expect to be a participant in that market post the exclusivity expiring. As to the new products you spoke about that really will depend on the efforts that Duramed puts behind it, and how they intend to position the product. We expect to be able to participate in the market as we would with any other OTC generic version like our nicotine gum and our nicotine patch products. So we have a lot of experience in this area and I think we will be well positioned to be able to deal with what comes along.
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