February 12, 2010
Paris/New York, February 12, 2010—Both the European Medicines Agency (EMEA) and the U.S. Food and Drug Administration have recently approved the long-awaited heat-stable 100mg tablet version of ritonavir, the antiretroviral booster drug produced by Abbott Laboratories.
It is hoped that generic manufacturers in developing countries will move forward with the development and registration of such boosted heat-stable PIs as fixed-dose combinations. Where there are potential patent barriers that prevent them from doing so, use should be made of safeguards in patent laws to ensure these are overcome.
• Register heat-stable ritonavir tablet widely in developing countries.
• Ensure that the price is affordable to patients in all developing countries (Abbott’s discounted price of US$83 per person per year for the heat-stable and soft-gel versions of ritonavir is only available for the absolute poorest countries).
• Develop a more adapted heat-stable paediatric formulation of lopinavir/ritonavir (such as soluble granules or sprinkles) for young children who can not swallow the existing tablet.
• Facilitate access to more affordable versions of ritonavir and fixed-dose combinations containing ritonavir by putting the patents on ritonavir into the Patent Pool for HIV medicines currently being set up by UNITAID.
© 2013 Doctors Without Borders/Médecins Sans Frontières (MSF)