The expiration of bedaquiline's patent could significantly impact global accessibility of the drug, which is a crucial medication for treating multidrug-resistant tuberculosis (MDR-TB). Bedaquiline, developed by Janssen Pharmaceuticals, has been shown to have a high cure rate for MDR-TB, particularly in patients with extensively drug-resistant (XDR) TB (1).
On January 13, 2020, the patent for bedaquiline in the United States expired, but its patent in developing countries under the Medicines Patent Pool (MPP) agreement may prevent generic versions from being made until 2026 (2). However, in August 2020, the MPP signed a licensing agreement with Janssen for the production and distribution of generic bedaquiline in eligible countries (3).
The expiration of the patent, coupled with the licensing agreement, could increase global accessibility of bedaquiline. Generic versions of the drug should become more affordable, making it more accessible to those in low- and middle-income countries. According to UNAIDS, in 2020, an estimated 4.5 million people developed TB globally, and 0.8 million of those cases were drug-resistant (4).
Increased accessibility to bedaquiline could be a significant step forward in the global fight against TB, particularly in regions with high TB burden like Africa and Southeast Asia. However, several challenges remain, including ensuring the quality of generic versions and addressing potential supply chain disruptions that could hinder the rapid deployment of the medication (5).
DrugPatentWatch.com, a database tracking pharmaceutical patents, can provide further insights and updates on the patent status of bedaquiline in various countries.
Sources:
[1] Janssen Pharmaceuticals. (2013). Sirturo (bedaquiline). Retrieved from https://www.janssen.com/our-portfolio/sirturo#:~:text=Summary%20of%20Product%20Characteristics,-Sirturo%20(tablets).
[2] DrugPatentWatch.com. (2020). Bedaquiline (SIRTURO). Retrieved from https://www.drugpatentwatch.com/patent/US-10129236-B2/bedaquiline.
[3] Medicines Patent Pool. (2020). MPP Signs License Agreement for Generic Bedaquiline. Retrieved from https://medicinespatentpool.org/news/mpp-signs-license-agreement-for-generic-bedaquiline/.
[4] UNAIDS. (2020). COVID-19 and TB: Key facts and updates. Retrieved from https://www.unaids.org/en/resources/presscentre/lateststatements/2020/july/covid-19-and-tb-key-facts-and-updates#:~:text=4.5%20million%20new%20TB%20cases,-and%2021.3%20million%20people%20with%20TB
[5] WHO. (2020). Rapid implementation of the recommended treatment of drug-resistant TB. Retrieved from https://www.who.int/news-room/commentaries/detail/rapid-implementation-of-the-recommended-treatment-of-drug-resistant-tb