[nickff]

>"Nothing except lack of motivation is stopping someone else from entering the market."

Have you ever looked at the cost of getting a new manufacturer of a drug approved by the FDA? FDA approval requires a lot more than motivation; if you disagree, I invite you to start manufacturing the drugs yourself (or even contracting it out).

[vonmoltke]

"Motivation" in the business sense of "can make sufficient return on investment", not the trivially reductionist sense of "I feel like making a new drug today". So regulatory costs affect the motivation.