Will generic supply of bedaquiline be accessible?

Source: The post is based on the article “Will generic supply of bedaquiline be accessible?”  published in The Hindu on 24th July 2023.

What is the News?

Johnson & Johnson’s patent on bedaquiline has expired recently. This long-awaited expiry will allow generic manufacturers to supply the drug, but J&J appears intent on maintaining its monopoly over the bedaquiline market.

What is Tuberculosis?

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What is the threat from Tuberculosis?

According to WHO, Tuberculosis was the world’s deadliest infectious disease before COVID-19 swept the world. 

Each year, nearly half a million people develop drug-resistant TB and nearly 10.4 million people develop drug-sensitive TB. 

One-third of the world’s population has latent TB, a version of the disease that can turn active as immunity falls. 

Nearly 2.8 million TB patients, the most in the world, live in India making it a national public health emergency.

What is Bedaquiline?

Bedaquiline is a medication used to treat active tuberculosis. Specifically, it is used to treat multidrug-resistant tuberculosis (MDR-TB) along with other medications for tuberculosis.

It was developed by Janssen Pharmaceutical (a subsidiary of J&J) around 2002. 

Several of the phase I and II clinical trials of the drug were sponsored by public and philanthropic organizations such as the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases, and the TB Alliance.

However, J&J has claimed sole ownership of it, protected by its aggressive patenting strategies.

What has Johnson & Johnson(J&J) done?

J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries.

It includes 34 countries with high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV. Over the past week, J&J has faced public outrage for seeking to extend its patent on bedaquiline.

However in India, the Indian Patent Office has rejected J&J’s secondary patent which would have extended its monopoly for four more years. Indian manufacturers will now be able to supply affordable, quality assured generic versions of bedaquiline in India as the primary patent expired.

It is estimated that, with the introduction of competition from India, the price of bedaquiline will reduce in the range of $48-$102 for a six-month treatment course.