Johnson & Johnson has announced its decision not to enforce its patents for SIRTURO® (bedaquiline) in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries. This move aims to encourage generic manufacturers to produce and sell high-quality generic versions of SIRTURO® in these countries without concerns about patent enforcement. However, the generics must meet quality and medical standards and be used exclusively in the designated countries.
The decision reflects Johnson & Johnson’s commitment to address the primary barrier to MDR-TB treatment, which is underdiagnosis, with a significant percentage of cases going untreated each year. The company has invested heavily in collaborative efforts over the past decade to enhance access to MDR-TB treatment.
SIRTURO® (bedaquiline) was introduced by Johnson & Johnson in 2012 as the first targeted tuberculosis medicine with a novel mechanism of action in over 40 years. Through partnerships and investments, the company has played a crucial role in improving TB treatment systems, healthcare professional training, resistance testing, surveillance, and supply chain security. Bedaquiline is now a key component of World Health Organization-recommended treatment guidelines for drug-resistant TB.
Furthermore, Johnson & Johnson recently granted a license to the Stop TB Partnership’s Global Drug Facility, enabling the procurement and supply of generic versions of SIRTURO® for most low- and middle-income countries. The company remains dedicated to building capacity, enhancing surveillance, and improving patient access to bedaquiline.
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