I am several steps removed from the industry but to my knowledge -<p>There is still a regulatory approval process to be able to manufacture the drug - so the cost and time required to receive this approval, then to market the drug as a generic alternative to the existing drug to a market that often doesn&#x27;t see itself as the ultimate payor (ie. the consumer thinks the insurance companies &#x2F; government are paying) and may prefer known names, and the original manufacturer&#x27;s ability to then lower the price of the drug all combine to push away competition on low volume drugs like this one.