Generics of Gilead Sciences' twice-yearly HIV pre-exposure prophylaxis (PrEP) Yeztugo (lenacapavir) are on the horizon, with India's Dr. Reddy’s Laboratories and Hetero Labs striking separate agreements with global access groups to support their respective launches.
Unitaid, the Clinton Health Access Initiative (CHAI) and Wits RHI—a South African HIV research institute—are teaming up with Dr. Reddy’s to provide the PrEP drug for $40 per year in 120 low- and middle-income countries starting in 2027. The $40 price point puts the long-acting injectable on par with daily oral PrEP meds, according to CHAI.
“It’s a new model for how innovation reaches those who need it the most,” CHAI’s CEO Buddy Shah said in a press release.
Yeztugo for PrEP requires an initial oral course of lenacapavir at the start of the twice-yearly prophylactic regimen. Through the Dr. Reddy’s agreement, the price of that oral course will cost no more than $17.
The Gates Foundation, meanwhile, is helping fund Indian generics maker Hetero Labs in a separate agreement designed to bolster access to generic Yeztugo.
Dr. Reddy’s and Hetero are two of the six generics makers that are permitted to make and sell generic Yeztugo in 120 high-incidence, resource-limited countries through Gilead’s royalty-free voluntary licensing agreements. The company signed on with the manufacturers in October 2024, before the drug’s June approval, to help ensure speedy access to generics.
With the signing of the new partnership deals, the generic marketplace for Yeztugo is taking shape. Multiple suppliers create necessary competition to keep prices low and offer procurement flexibility, CHAI noted.
Besides its Hetero agreement, the Gates Foundation is taking things a step further with more than $80 million in planned “catalytic investments” to boost market readiness, scale delivery and shorten the timeline for generic entry, the organization said in a release.
Still, some activists argue that the 120-country stipulation in Gilead’s licensing agreements leaves out several key regions and could hinder broad global access.
“Any restrictions on access to an affordable generic price for this essential prevention tool is unacceptable,” Health Global Access and Prevention (GAP) Executive Director Asia Russell said in a press release issued by Public Citizen.
According to Public Citizen, more than one in four new HIV infections worldwide occur in 26 countries left out of Gilead’s licensing agreements—a group that includes Argentina, Brazil, Mexico and Peru.
However, Gilead is seemingly aware of the missing components to its existing global access plans. The company has said that it is pursuing “multiple strategies” to support access in middle-income countries with a high burden of HIV that are not covered by its voluntary licensing program or other agreements, including tiered pricing and public-private partnerships.
Other than the licensing agreements, Gilead is working on boosting further access through its partnerships with the United States President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, which agreed to provide Yeztugo access for up to 2 million people over three years in certain countries.