First, a couple of examples of what I’m talking about, from recent experience:
My doctor suggested that I might benefit from a shiny new stomach medication called Zegerid. It’s Prilosec (omeprazole)… combined with sodium bicarbonate. Yes - baking soda. I did some calculations and it looks like one capsule has a grand total of one tenth of a teaspoon of bicarb. Plus an amount of omeprazole that would cost me less than 50 cents at the drugstore.
I looked up the price at my online pharmacy and my share (if they even covered it) would be something like 150 dollars a month for 2 pills a day. For something I can get OTC for less than 30 dollars a month (INCLUDING a pinch of baking soda).
I’ve also used Arthrotec, which is diclofenac + misoprostol. Diclofenac by itself would cost me about 5 dollars a month, The misoprostol would cost me about 20 dollars a month. The combination, as brand name Arthrotec, costs 67 a month. All of these are after my insurance pays their share (they don’t much like shelling out for any of them, for obvious reasons).
Doubtless there are boatloads of other examples, these are just two recent ones I could think of.
So the GQ: All of these individual components are available as generics, obviously. Are there extra approval steps when drug companies want to “reformat” (intentional use of that word, vs. “reformulate”) such things? Is the patent protection as long as for a new drug? (this is in the US, obviously)