WPI hasn’t mentioned Lovenox to investors in a very long time, as far as I know. Lovenox has never been included in WPI’s EPS guidance for any period.
Amphastar previously sued the FDA when it didn’t get FDA approval for Lovenox, so this case could have political overtones that caught even WPI by surprise.
I don't have a link (perhaps in Dew's ReadMe somewhere?) but when the FDA removed a block on Heprin shipments the company was using in developed there was a letter stating numerous deficiances (I believe Amphastar sued the FDA to allow the shipment). It appeared they weren't close but I guess that was just a superficously appearence.
My response that I did on the Motley Fool. Gist, this probably bodes well for generic copaxone, but is very probably catastrophic for enoxaparin absent an successful patent suit. So really, the stock is a tremendous buy on generic copaxone, and right where it probably should be for another generic enoxaparin. Since we can only invest going forward and not would be, could bes, should bes, what is the best course of investment action from this point in time is the question.
I linked to the below site that explains the Orange Book categorization and the use of the term "Thereapeutic Equivalence". From the reading of this, there does not appear to be a large gray area of what the term means, if the term is being used correctly.
Yes, labeling discussions is ambiguous one would think, but it could refer to something more innocuous. This remains ambiguous, but I am not hanging my hat on it (although, you know, keep hope alive and all).
The good news is, I expected about a 33% hit on a generic enoxaparin approval, and so it has hit. It does nothing to the value of copaxone and the much more favorable economics therein. If just the litigation overhang would part. FDA may be starting to get in a groove on more complex generic approvals as they have now had substantial experience in this category of generic with success.
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