Darunavir (boosted with ritonavir) is recommended by WHO as a component of third-line antiretroviral treatment regimens, and as an alternative to second-line regimens for adults. Duranavir is also known as DRV.
There appear to be limited patents on darunavir in most low-income countries. The compound patent has expired. Secondary patents, such as those on the pseudopolymorph (a different form of the same drug) or on combinations, may potentially delay competition in certain countries, that are not covered by the commitment not to enforce patents. Patents on ritonavir (r) or cobicistat (c) would also affect the sale of DRV/r or DRV/c in certain jurisdictions.
The compound patent on darunavir expired in August 2013 in jurisdictions in which it had been granted. A method of use patent is not in force in developing countries.
Patents on the pseudopolymorph and/or on the combination with ritonavir have been granted in Albania, ARIPO member countries, China, EAPO member countries, Indonesia, Mexico, Philippines, South Africa and Turkey, and are pending in Brazil, India, OAPI member states and Viet Nam.
A commitment not to enforce patents on darunavir in sub-Saharan Africa and least-developed countries has been announced by the patent holder. The commitment was extended to 128 countries for paediatric products in 2015. In addition, a licence was granted to one manufacturer for the sale of darunavir in India.
Darunavir requires boosting with ritonavir or cobicistat. While no combination with ritonavir has yet received regulatory approval, the combination with cobicistat was registered by the European Medicines Agency in November 2014 and by the United States Food and Drug Administration in January 2015. Clinical trials are ongoing for the combination DRV/TAF/FTC/COBI.