As tuberculosis (TB) remains the world’s deadliest infectious disease, civil society groups and members of ITPC’s Make Medicines Affordable (MMA) campaign are calling for urgent action to ensure life-saving treatment reaches those who need it. Despite a decline in the price of Bedaquiline (BDQ) — a key component of the all-oral TB treatment regimen to multi-drug resistant TB (MDR-TB) — the cost of other important MDR-TB drug – delamanid – remains a barrier for many patients due to restrictive practices by pharmaceutical companies.
“As the patent holder, Otsuka has prevented access to improved TB treatment due to its exorbitant prices. On World TB Day, our message is clear: Otsuka must end its monopoly on delamanid. As TB is the world’s top infectious killer, access to affordable TB treatment is truly a matter of life and death,” stated Sergiy Kondratyuk from the MMA campaign, led by ITPC Global.
According to the WHO, more than 10 million people continue to fall ill with TB every year. Despite it being a preventable and curable disease, an estimated 1.5 million people die from TB each year.
Otsuka’s approach to ensuring access to delamanid is the same as J & J’s approach for another important MDR-TB medicine – bedaquiline. The result is unaffordable, and inaccessible life-saving drugs, which is why communities should demand better access to delamanid.
Since its introduction on the market monopolies on BDQ, obtained at country-level, have prevented access to this ground-breaking TB treatment. Although the drug’s development was made possible due to public funding and philanthropic contributions, the patent holder J & J continued to profit from its inequitable pricing of BDQ.
Patients who used BDQ to treat TB, which is recommended by the WHO, have improved treatment times, cutting lengths from 24 months to 9 to 12 months. The treatment also causes less side effects and can be administered at-home instead of at a hospital.
As of January 2025, the price of generic BDQ is $90 USD per adult treatment course from Lupin and Macleods (Indian pharmaceutical companies which partnered with GDF to reduce the price of TB treatments), which is less than 3 times compared to the $272 price for J & J’s branded product, charged to LMICs in 2022 .
Community Groups Fought for Access using Patent Oppositions
For years, civil society groups made global demands for more affordable BDQ, which were ignored by J & J. Instead, the company established multiple, worldwide patent monopolies worldwide on BDQ. J & J is seeking to ‘evergreen’ its patent position on BDQ by filing secondary patents in various countries, which, if granted, would extend the block on competition and keep the drug out of reach.
In response, ten community-based organizations and MMA members, including ABIA in Brazil, DNP+ in India, Initiativa Pozitiva in Moldova, TNP+ in Thailand, 100% LIFE in Ukraine, and VNP+ in Vietnam filed 21 patent oppositions against secondary patent applications or patents. These patent oppositions pertain to BDQ in Belarus, Brazil, India, Indonesia, Kazakhstan, Kyrgyzstan, Moldova, Thailand, Ukraine, and Vietnam— where J & J’s secondary patents or patent applications on bedaquiline, if granted, could last at least until 2036. Several oppositions are still currently under consideration by the patent offices or courts, as J & J continues supporting those in force, contrary to its non-enforcement announcement.
In Brazil, the National Institute of Intellectual Property (INPI) accepted MMA member ABIA’s requests to reject the patent application for bedaquiline fumarate salt in June 2024 and nullified another patent for pediatric dispersible bedaquiline in August 2024, thus demonstrating the power of advocacy by civil society groups.
In Thailand, after community groups filed patent oppositions, two BDQ patent applications (for BDQ fumarate salt and pediatric formulation) were abandoned by J & J in 2024. In February 2025, the Department of Intellectual Property rejected another two BDQ patent applications (pertaining to treatment of MDR TB and treatment of latent TB), after J & J appealed the initial decisions. This is a definitive decision, signaling the absence of patent barriers on BDQ manufacturing in Thailand. This major success follows years of campaigning by MMA partner TNP+ alongside the AIDS Access Foundation (AAF).
The coordinated mobilization in response to J & J’s evergreening attempts of Bedaquiline highlighted how cross-regional collaboration can successfully confront patent abuses, even if the path to widespread access remains challenging.
Price Gouging of BDQ
In 2020, the GDF brought the price of BDQ down to $272 per treatment course, which allowed some Low- or Middle-Income Countries (LMIC) to access affordable generic versions of BDQ – but it excludes some of the countries with the most urgent need for this drug. Also, experts have estimated that generic BDQ could be profitably mass-produced for as low as $48 per treatment course.
After India’s patent office rejected the patent application on bedaquiline fumarate salt in March 2023 — which came as a result of years of Indian community groups advocacy — J & J announced with GDF a voluntary license deal allowing supply of lower priced generic versions for many LMIC and additionally J & J reduced the price of its branded version of the drug from $272 to $130 per treatment course. However, as per the terms of a deal, several countries with high burden of the disease, including Russia, China, Belarus and Ukraine, were unable to access the lowest-priced generic until the corporation’s additional patents expired.
In September 2023, under sustained pressure from civil society groups and massive public pressure, Johnson & Johnson announced that it will not enforce patents for BDQ for MDR-TB treatment in 134 Low- and Middle-Income Countries. The diverse strategies employed by many treatment activists — including patent challenges, treatment literacy initiatives, and global advocacy — clearly influenced J & J’s positioning. However, the company continues to support in force its evergreening patents or patent applications in relation to bedaquiline in LMICs.
“While 3 times price reduction on bedaquiline allows quick scale up of coverage with BPaL regimen to people in need, price of delamanid remains very high ranging between $800 to $1190 limiting access to this life-saving treatment. Otsuka must immediately withdraw all existing delamanid patents and pending patent applications to ensure legal assurance for any manufacturers willing to produce generic versions of this drug” stated Othman Mellouk, Access to Medicines & Diagnostics Lead at ITPC Global.
