OBJECTIVES: Access to effective, low cost antiretrovirals (ARVs) is a public health imperative. This study compared ARV approvals and prices in Saudi Arabia (SA) and the United States (US) in 2014.  METHODS: US Food and Drug Administration (FDA) ARV drug approvals data were collected from the FDA website. Likewise, ARV drug approvals and prices in SA were collected from the Saudi Food and Drug Administration (SFDA) website. ARV drug prices data were also collected from the World Health Organization (WHO) website. Descriptive analysis and paired t-test were performed. Statistical significance was set up at 0.05% RESULTS: In 2014, there were 27 ARVs and 9 fixed-dose combinations of ARVs approved by the FDA. The WHO listed 22 ARV single active ingredients and 16 combinations. Overall, 29.6% of the single active ingredients and 33.3% of the combinations approved by the FDA were marketed in SA. The FDA approved generic ARVs for 18.5% of the single active ingredients and for 22.2% of the combinations. The WHO listed generic ARVs for 31.8% of the single active ingredients and 100% of the combination drugs. No generic ARV drugs were approved by the SFDA.  Price data were available for 13 drugs. ARV drug prices in SA were in median 21.14 times higher than the ARV drug prices listed by the WHO (range 2.2 - 99.8 times) (p<0.0001). CONCLUSIONS: Less than one third of the ARV drugs approved by the US FDA were marketed in SA in 2014. Prices in SA were significantly higher than prices listed by the WHO. Lack of SFDA approved generic ARVs may explain the price difference. Approvals of low cost generic ARVs remains a public health priority in SA to improve quality of life of HIV patients in the country.