I'm not certain you're correct when you state
"Also, in some cases what you are saying is, shall we say, well, a bit wrong actually. For example, generic Pentosan is actually manufactured all over the world, albeit (officially) for veterinary use, and has been for years, so it can't be that hard, can it? Or can it? Who knows? Not me, and not you either I suggest. And iPPS, by the way, is just Pentosan + H2O + not much else; no patents on it at all."
The inability to readily manufacture a generic form of iPPS (given it is not a 'traditional' form of drug manufacture, but a process involving the extraction of the active ingredient from Beech bark) does present a major barrier to entry for any generic manufacturer.
PPS is certainly not manufactured all over the world. This from one of the analyst reports on the Paradigm website - there has been a heap written about this. (And if you can find a generic version anywhere online - I stand corrected)
From what I understand, J&J did try and get a generic version sourced (maybe from India?) - but an inability to do so meant they reverted back to getting supply from Bene.
IMO the possible threat posed by a generic version would have been one of the first things PAR would have considered before embarking on this many years ago. And no Pharma company will invest $40million in a trial - only to see all sales going to a cheaper generic version.
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