What is Bedaquiline?
Bedaquiline is an anti-tuberculosis drug.
Bedaquiline is a crucial drug in the treatment of multidrug resistant TB patients for whom the first-line drug treatment — using Isoniazid, Rifampicin, Pyrazinamide and Ethambutol — has stopped working.
Who made bedaquiline?
The anti-tuberculosis drug Bedaquiline is manufactured by J&J.
Johnson & Johnson’s (J&J) is a U.S. pharmaceutical giant.
Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002.
The recent WHO recommendation of bedaquiline being a core drug for the treatment of drug-resistant tuberculosis (DR-TB) is largely based on the evidence produced through collective efforts.
However, J&J has claimed sole ownership of it, protected by its aggressive patenting strategies.
What has J&J done?
Johnson & Johnson’s patent on bedaquiline expired on 2023 July 18.
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.
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.
A first of its kind 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.
Researchers estimate 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 — which is three to six times lower than the current globally negotiated price paid by countries ($272) when it is procured through the GDF.
Will the drug be available in India?
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.
In India, a ‘pre-grant opposition’ was filed by a patient group and two TB survivors — both of whom had to endure the more toxic DR-TB treatments that lasted up to two years and caused excruciating side effects: they both lost their hearing.
As a result of their legal challenge, in a landmark decision, the Indian Patent Office rejected the U.S. corporation 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 on July 18.
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