Doravirine (DOR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adult patients with no prior antiretroviral treatment history. However, the evidence of clinical benefits over the standard of care is still unclear.

Recent phase III studies (MK-8591A-051 and MK-8591A-052) have demonstrated that doravirine, when administered as a once-daily oral treatment in combination with islatravir (DOR/ISL 100 mg/0.25 mg), is both safe and non-inferior to commonly used antiretroviral therapy (ART) regimens in virologically suppressed individuals with HIV-1. The US FDA has accepted the NDA for this investigational two-drug regimen candidate, with an expected date of decision announcement in April 2026.

Primary patents on doravirine compound and its combinations with other anti-HIV agents have been filed in many LMICs and are expected to expire in 2031. In few countries, the patent term may be extended by another five years, until 2036. While bilateral voluntary licences have been granted to generic manufacturer for 86 countries, public information on such licences is limited. The existing licence for DOR may enable access to generics of DOR+3TC in 86 LMICs; however, the development status for licensed generic DOR versions is unknown.

Patent & licence data in LMICs

Acronyms & abbreviations list