You have to wonder how many (if any) ANDAs have already been filed for these Pfizer products for sale within the US.

When it is another company looking to get a piece of the pie- an ANDA is filed and the approval results in a generic.
When the major manufacturer files an ANDA it- it is called “adjustments” and the product keeps “branded drug” pricing & status.

Where it gets interesting is in looking at the innovator numbers (AUC0, T-1/2, cmax, etc.) whether they be compared to a competitor’s ANDA or as compared to the major manufacturers own ANDA. Not going to elaborate- but come on. Bioewhatency? That’s all I’m comfortable saying about that.

At least in Japan they’re going to call them generics.