Will generic supply of bedaquiline be accessible?

Last Updated25/07/2023

Bedaquiline has now become the cornerstone to cure drug-resistant tuberculosis (DR-TB).
Recently, Johnson & Johnson’s patent on bedaquiline has expired.
This will allow generic manufacturers to supply the drug.
However, J&J appears intent on maintaining its monopoly over the bedaquiline market.

J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries.
- Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002.
It includes 34 countries with a high burden of TB, multidrug-resistant TB (MDR-TB), and TB/HIV.

Tuberculosis is an infection caused by Mycobacterium tuberculosis.
It can practically affect any organ of the body.
The most common ones are lungs, pleura (lining around the lungs), lymph nodes, intestines, spine, and brain.
Transmission: It is an airborne infection that spreads through close contact with the infected, especially in densely populated spaces with poor ventilation.
Symptoms: Cough with sputum and blood at times, chest pains, weakness, weight loss, fever and night sweats.
Treatment:
- TB is a treatable and curable disease.
- It is treated with a standard 6-month course of 4 antimicrobial drugs
- Multidrug-resistant tuberculosis (MDR-TB) is a form of TB caused by bacteria that do not respond to isoniazid and rifampicin, the 2 most powerful, first-line anti-TB drugs.
- MDR-TB is treatable and curable by using second-line drugs such as Bedaquiline.
- Extensively drug-resistant TB (XDR-TB) is a more serious form of MDR-TB caused by bacteria that do not respond to the most effective second-line anti-TB drugs, often leaving patients without any further treatment options.

As per 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 patients, the most in the world, live in India making it a national public health emergency.
Globally, DR-TB is a major contributor to antimicrobial resistance and continues to be a public health threat.

Other DR-TB drugs like linezolid have decreased in prices by over 90% with generic competition once Pfizer’s patent expired in 2015.
Therefore, national TB programmes are waiting for the generic supply of bedaquiline from Indian manufacturers to reduce prices.
However, Indian manufacturers will not be able to export the medicine to 34 of the 43 countries with a high burden of TB.

A deal between J&J and the Global Drug Facility (GDF), a non-profit distribution agency housed in the WHO, could expand access to the drug.
When procured through the GDF, it would be three to six times lower than the current globally negotiated price paid by countries.
Researchers estimate that, with the introduction of competition from India, the price of bedaquiline will reduce

The GDF deal claims to cover the majority of low-and middle-income countries
However, some of the countries hardest hit by DR-TB will not benefit.
Eastern European countries and China with a high burden of TB are believed to be out of the agreement.
Countries like South Africa are not purchasing from GDF and with the ever-greening patent inforce till 2027, it will not get access to generic Bedaquiline.