End of the Bedaquiline patent – a crucial development for moving forward affordable drugs, diagnostics, and vaccines for infectious diseases in low- and middle-income countries

Abstract

When Johnson & Johnson (J&J) developed the new tuberculosis (TB) drug bedaquiline (Sirturo) [1], it was one the few new drugs to have been conditionally approved by the United States Food and Drug Administration (FDA) in 2012 for treatment of multidrug resistant tuberculosis (MDR-TB). It offered renewed hope to patients providing a unique opportunity to radically transform management of MDR-TB to shorter, easier-to-administer, and more patient-tolerable treatment regimens [2]. Evaluation in clinical trials over the ensuing seven years showed that bedaquiline was a game-changer, demonstrating substantial improved treatment outcomes among people with MDR-TB and extensively drug-resistant TB (XDR-TB) [3]. J&J, like all pharmaceutical companies who hold the patent rights on drugs, had the sole authority over setting the high price of bedaquiline..