A coalition of families and patient advocates has announced the launch of a community-led buyers' club to distribute a low-cost generic version of Vertex Pharmaceuticals' lifesaving cystic fibrosis drug Trikafta, marking a significant challenge to the company's global monopoly over the breakthrough therapy.
The initiative, announced at the North American Cystic Fibrosis Conference in Seattle, will offer the generic version at $6,375 per child annually—more than $360,000 below Vertex's US list price of $370,000. The generic drug, branded "Triko," will be manufactured by Bangladesh-based Beximco Pharmaceuticals and coordinated through a buyers' club model for global distribution beginning spring 2026.
Addressing Critical Access Gaps
Cystic fibrosis, a rare inherited condition causing severe lung damage and shortened life expectancy, affects an estimated 188,000 people worldwide. However, only about 27% of patients currently receive treatment, according to campaign data from the Right to Breathe movement, which spearheaded the initiative alongside advocacy groups including Just Treatment, Third World Network, and Health Justice Initiative.
"This is a historic moment," said Gayle Pledger, who heads the Right to Breathe campaign, in a statement. "We've watched children suffer and die while a treatment sat on the shelf, priced out of reach. Today, that changes. We've proven that patient power can change what billion-dollar corporations refuse to."
The stark access disparity reflects Vertex's pricing strategy and patent protections, which have limited the drug's availability primarily to high-income countries. Only one low- or middle-income country offers reimbursement for Trikafta, compared with 35 high-income nations.
Legal Manufacturing Framework
Beximco's ability to produce the generic legally stems from Bangladesh's exemption from enforcing pharmaceutical patents as a least-developed country under World Trade Organization rules. The company, one of South Asia's largest pharmaceutical exporters, stated its goal was to make the therapy accessible and sustainable for health systems in developing markets.
The cost differential is dramatic: Beximco's product will allow 58 children to be treated for the same cost as a single patient on Vertex's formulation. For adults, Beximco plans to market Triko at $12,750 per year, alongside a generic version of ivacaftor, one of Trikafta's components, priced at $5 per tablet.
WHO Recognition and Patent Challenges
The World Health Organization recently classified Trikafta's active ingredients—elexacaftor, tezacaftor, and ivacaftor—as essential medicines, underscoring their clinical importance. This designation comes as patient advocates have mounted legal challenges to Vertex's patent strategy in multiple jurisdictions.
In India, where Beximco sources raw materials, the patent office rejected Vertex's application for a modified form of one ingredient last year, ruling that it lacked enhanced efficacy. Activists have also filed challenges in South Africa, Brazil, and other countries seeking to invalidate secondary patents that extend exclusivity through what critics call "evergreening" tactics.
Building on Previous Success
The buyers' club model recalls a similar patient-led initiative in 2019 that helped unlock access to Vertex's earlier cystic fibrosis modulators in the UK following years of price disputes. However, organizers argue this new model goes further by using legal flexibilities in global trade rules to create a parallel pathway to treatment for patients in countries without formal access programs.
Public health observers have described the move as one of the most consequential examples to date of how patient advocacy, civil society pressure, and generic manufacturing can combine to challenge pharmaceutical monopolies in rare diseases. For thousands of families in low- and middle-income countries, the initiative represents a potential shift in the global politics of drug access, with patients leading the way rather than policymakers or corporations.
