India's TB programme: Low cost generics of J&J's MDR-TB drug on the anvil

Indian Patent Office's decision on J&J's bedaquiline came on the eve of World Tuberculosis Day, marked on March 24 every year, to raise public awareness & to boost efforts to end the TB epidemic

India’s tuberculosis eradication programme is set for a boost after the Indian Patent Office rejected the application of American pharma giant Johnson & Johnson to extend its monopoly on a key TB drug – bedaquiline, which is set to expire in July. The drug is considered a key medication against multi-drug resistant TB.

The decision that came on the eve of World Tuberculosis Day - marked on March 24 every year - is going to bring smiles on the faces of TB patients in the country which reported 2.14 million TB patients in 2021, 18 per cent more than the number in 2020 (WHO Global TB Report 2022). India’s TB incidence for the year 2021 is 210 per 100,000 population.

The drug is available for free now to Indian patients, said a J&J spokesperson. “In India it is available only through the government route, and not through retail pharmacies. Therefore, for the patient, it is free,” the company clarified.

Bedaquiline had received a conditional approval by the USFDA in 2012 for treatment of multi-drug resistant TB, and in 2018 the WHO MDR-TB guidelines prioritised bedaquiline (developed by J&J arm Janssen) among treatment for MDR-TB. In 2019 the drug was launched in India.

India had procured over 20,000 doses through a global four-year donation programme by J&J and the US Agency for International Development (USAID) till 2019. In July 2020 J&J slashed prices of the drug by 32 percent for 135 eligible countries including India to $340 (Rs 27,200) for a six-month regimen.

“The patent application in question – for a formulation of bedaquiline – was filed in India over a decade ago, as part of standard procedures when developing new medicines,” a J&J spokesperson said.

The company added that whether this patent was granted or not, a formulation patent would not have prevented generic manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when J&J’s API patent expired in India.

Several generic drug makers are set to start making copy-cat versions of the drug which was set to lose patent in July. As such, the industry estimates that the low cost generics would be soon available for the government to procure. “This would boost the government MDR-TB programme as there would be low cost generics, and the prices could be lower by 50-80 percent from the originator molecule. Moreover, if allowed, the India-made drugs could also be made available at a retail level,” said a pharmaceutical executive who did not wish to be named.

On Thursday, the India Patent Office delivered the judgment on a plea filed by two TB survivors, Nandita Venkatesan and Phumeza Tisile. “We remain committed to supporting India’s efforts to end TB and look forward to participating in the TB high-level summit hosted by Prime Minister Modi later this week,” J&J further said.

The move comes at a time when India is setting ambitious targets to eradicate TB from the country by 2025. Typically, TB drugs are procured by the Central government agencies in India and distributed to patients. The private market for TB drugs is relatively low, but with higher incidence of non-pulmonary and MDR-TB several people are also buying drugs on their own as recommended by the clinicians.

Médecins Sans Frontières/Doctors Without Borders (MSF), along with petitioners to this challenge, urged the Indian Patent Office in January to reject the secondary patent application filed by J&J. MSF also called on the pharmaceutical corporation to withdraw the patent application in India and other countries where equivalent patents remain, and stand by its statement that generic versions should be made available in 2023.

Earlier in January the Delhi High Court had advised the assistant patent controller to hear Hyderabad-based drugmaker Natco Pharma’s opposition to Novartis’ patent for the latter’s blockbuster heart failure drug (a combination of sacubitril and valsartan). This decision by the court opened doors for Indian pharma players to launch their generic versions of the heart failure drug Vymada (sold globally as Entresto). 

• The drug sold only through Govt program in India is currently available free of cost to TB patients
• With low cost generics entering market, govt procurement set to rise