I've thought about that possibility a few times, but they've sort of mislead investors if it turns out to be true. QSM is supposed to be another internally developed program whereas Copaxone would be a partnered program. I like that idea a whole lot more then Methylcobalamin.
The Copaxone patents start running out mid/2015, but I give generics a less then 50% chance for gaining approval without trials. If they have to run clinical trials their screwed & a generic might never make it onto the market. TEVA would be able to retain a large percentage of the market since there wouldn't be a big cost reduction since generics would need to recover the trial costs & they would be daily dosing as compared to 3 x week.
On the other hand if generics get approval then TEVA is screwed. Their only advantage will be the 3 x dosing, but its hard to believe insurance companies wouldn't force individuals toward the generics.
I've thought about contacting Howarth to see if he could explain the necessary steps for getting an injector approved once TEVA gains approval for 3 X dosing. I think TEVA would run a small trial to show PK/PD equivalence vs standard SQ. (Take a few weeks) File an sNDA with the necessary documents. There are different categories for sNDA's & I'm unsure where the injector would fall. This might be classified as a moderate change where TEVA can file the sNDA & put the injector on the market within 30 days of the filing.
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