rkrw’s post in #msg-53399610 seems to have you more confused on this subject than you were before. Let’s recap—there are two ways to try to make money from an off-patent medicine:
1. Develop a new formulation, run at least one clinical trial, and seek FDA approval as a branded drug under the 505b2 pathway. If there are already multiple generics on the market (in which case none of the existing vendors is making much money), this approach is the only hope for generating material profits.
2. For a hard-to-copy large-selling drug where there is no generic already on the market, a vendor can make much more money by getting FDA approval for a substitutable generic than it can by developing a similar branded drug. This is what MNTA has done with Lovenox and hopes to do with Copaxone.
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