ECAT Urges Otsuka to Lower Delamanid Price and Remove Barriers to Access in EECA Countries

11 October 2026

In September, representatives of the Eurasian Community for Access to Treatment (ECAT) sent a letter to Otsuka calling for urgent action to expand access to delamanid, one of the key drugs used to treat drug-resistant TB. One of the main demands is to reduce the price of the medication to under US$300.

Delamanid is a critical drug for people with multidrug-resistant and rifampicin-resistant TB, particularly for patients who are not suitable for the priority BPaLM/BPaL regimens. In the 2024 WHO brief update and the 2025 treatment guidelines, delamanid-containing regimens are recognized as important alternatives, including a six-month regimen based on bedaquiline, delamanid, and linezolid combined with levofloxacin and/or clofazimine.

According to procurement monitoring data, in 2025, purchasing prices for delamanid in the Eastern Europe and Central Asia (EECA) region ranged from approximately US$1,190 in Uzbekistan and US$1,218–$1,400 in Russia to US$2,196 in Kazakhstan for a six-month treatment course. These prices impose a significant burden on national budgets: in Uzbekistan, US$1.05 million — or 34.6% of the total TB drug budget — was spent on purchasing delamanid in 2025; in Kazakhstan, the spending reached US$2.4 million, representing 23% of the total budget.

At the same time, a study by Andrew Hill and colleagues evaluating production costs inclusive of a reasonable profit margin demonstrates that with competitive, large-scale generic manufacturing, a six-month course of delamanid could be sold at a substantially lower price — ranging from US$30 to US$96.

ECAT representatives also drew attention to patent and licensing barriers. Specifically, the letter highlights Eurasian patent application EA 202590299 for a “solid dispersion containing delamanid.” According to ECAT’s assessment, because the application relates to a formulation modification rather than a new active substance, granting additional patent protection could create new obstacles to generic competition in the region. Territorial restrictions within existing licensing agreements also remain a separate challenge.

In its appeal, ECAT calls on Otsuka to:

Reduce the price of a six-month course of delamanid to under US$300;
Withdraw Eurasian patent application EA 202590299 and refrain from filing new secondary patent applications for minor modifications of delamanid;
Publicly commit not to enforce existing patents in a manner that obstructs the registration, production, import, procurement, or supply of quality-assured generic versions of the drug;
Expand the geographic scope of existing licensing agreements, including the Viatris license, to enable registration and supply of delamanid in EECA countries;
Grant necessary rights to other qualified generic delamanid manufacturers to supply the region, including through the Stop TB Partnership’s Global Drug Facility, UNDP, and national procurement systems.

ECAT representatives expressed readiness for dialogue with Otsuka and proposed discussing concrete steps to broaden timely access to delamanid for people living with drug-resistant TB across the region.

This article was translated into English using AI and reviewed by a human editor before publication. You can find the original article in Russian here.