Pharmaceutical Company Signs Agreement to Produce Generic Versions of Long-Acting PrEP

ViiV Healthcare announced today that together with the Medicines Patent Pool (MPP) have signed sublicence agreements with Aurobindo, Cipla, and Viatris to manufacture generic versions of Apretude (cabotegravir extended-release injectable suspension) for HIV pre-exposure prophylaxis (PrEP). This is enabled by the signing of a voluntary licensing agreement for patents relating to cabotegravir LA for PrEP with MPP in July 2022.

The licensing agreements should enable potentially millions of people living in areas most impacted by HIV to access this PrEP.

“The signing of sublicence agreements with three generic partners is an incredibly important milestone towards enabling broad access to this medicine in countries where there is the highest burden of new HIV cases,” ViiV Healthcare CEO Deborah Waterhouse, said in a statement.

In December of 2021, FDA approved cabotegravir for PrEP for adults and adolescents to reduce the risk of HIV. It was indicated to be given first as 2 injections, 1 month apart, and then every 2 months thereafter.

Through the MPP-ViiV Healthcare agreement, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to required regulatory approvals being obtained. Aurobindo and Viatris will manufacture in India; Cipla will manufacture in India and has plans to manufacture in South Africa as well.