ABSTRACT
This chapter begins with a discussion of how generic drug companies have found ways to navigate the US pharmaceutical industry regulations to their advantage. The purpose of the generic drug market is to manufacture generic versions of branded drugs that no longer have patent protection. The chapter highlights two biopharmaceutical companies: Mylan and Turing Pharmaceuticals. It illustrates the path Mylan has taken to actively navigate the legal system, starting with exclusive deals with big biopharmaceutical companies, petitions, legal lawsuits reaching the high courts and, finally, to a monopoly product with an eye-gouging price. From a business model perspective, however, Mylan was praised for its prompt execution at securing future revenues by collaborating with drug companies whose patents were close to expiring. Turing Pharmaceuticals, an opportunistic pharmaceutical company, took advantage of well-intended regulations meant to protect patients and companies who spend valuable time, money, and human resources to develop new therapeutics for rare diseases with small number of patients.
