The War Over Lipitor

A generic version of the world’s top-selling prescription drug – Lipitor – was anticipated this fall, and Katherine Eban, writing for Fortune, suggests that “Generic-drug companies are now feuding like greedy relatives at Lipitor's graveside.” Exclusive rights to sell drugs end 20 years after the patent application is filed. The first generic maker to file patent for a viable substitute – in Lipitor’s case, India’s largest pharmaceutical firm Ranbaxy– can gain exclusive rights for six months. Eban describes complex regulatory processes and the battle to make the first generic version: The first-to-file substitute can charge 70 percent of the drug’s original price; after six months, other competitors move in and the price drops to 5 percent. A decision is expected soon from the US Food and Drug Administration. Generics reduce profits, and delays in generics can delay treatment. Regulatory review targets consumer safety, yet predicting outcomes can lead to huge profits. – YaleGlobal