Why can't the patient buy a drug from India for a fraction of a cost? It's not standing on the street corner or anything. Even flying to India to get a drug seems cheaper then paying $45K a year. You have to differentiate simple compounds vs proteins or more complex structures. There are drugs that generic versions of could be materially different due to the reverse engineering of the product. But on the level of this drug, there really is no difference between a generic version and the brand name except for the availability in EU pharmacies. But with internet and globalization, a lot of old concepts and businesses went into oblivion. Music business is one example. Americans as a rule don't go to other countries to get medical help. Europeans do that more freely. If you go to India (but you probably don't have to as you can do it through the internet) and pay next to nothing for the drug, then some people will do that. SOme will buy brand name no matter what. Some will not be able to afford the brand name and will be forced to find ways around it anyway.
Complicated protein based or drugs with tricky know how production are somewhat protected against what is actually a piracy. This thing is existing compound that will be used for this particular disease, so in China and India and Russia they can manufacture generic version and sell it on the internet (which is what they will try to do anyway). Have you seen the performance of traditional pharmas with the advent of generic drugs and globalization? Its terrible. The drug needs to be complex, branded well and difficult to reverse engineer to be valuable source of sales.
The company claims to have proprietary methods of administration that minimize side effects. If you compare the "microcoating" on Bayer aspirin with that on generics, you see that these little refinements can be hard to duplicate too.
For at least the first few years after it's introduced, optimal administration of pirfenidone will require a physician in the loop. A guy can lose his license for administering industrial chemicals rather than drugs.
That all said. I'm told that more money is now made smuggling "Viagra" than smuggling heroin.
So non-licensed sources of pirfenidone are an issue, but not a killer.
Good luck bringing in a fine white powder from southeast asia or anywhere else. Synthesis of simple organic molecules can include highly toxic reaction byproducts. Sometimes removing those byproducts is not a simple or inexpensive task.
However you are correct: paying $25,000 or more for annual supply of a compound that costs less that $1,000 to produce is an invitation to black marketeers. The hope for extreme profit is what drives investors.